ASSAYS TODAY FORMULATIONS IMPROVE YOUR PHARMACEUTICAL SCIENCES ANALYTICAL DEVELOPMENT. PHARMACEUTICAL ANALYSIS GUIDE VOL.

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1 PHARMACEUTICAL ANALYSIS GUIDE VOL. Look inside to see how you can easily achieve Resolution Ruggedness Reproducibility IMPROVE YOUR FORMULATIONS ASSAYS TODAY PHARMACEUTICAL SCIENCES ANALYTICAL DEVELOPMENT

2 If Phenomenex products in this brochure do not provide at least an equivalent separation as compared to other products of the same phase and dimensions, return the product with comparative data within 45 days for a FULL REFUND. Trust Phenomenex for reliable products that are proudly manufactured at Phenomenex headquarters in Torrance, CA USA

3 Designing Safer, More Effective Drugs Pharmaceutical formulations has a growing need for better analytical performance as the excipients (or nonactive ingredients) along with the active ingredients are becoming more scrutinized by regulatory agencies. Scientists are now looking for ways to more easily qualify and quantitate a large variety of ingredients. Take a quick look at our solutions for ways you can improve your formulations analysis, today. What and Why? Binders What are excipients?...p. 4 Pharmacopoeia Classifications (USP & Ph. Eur.)... pp. 5-6 Allowable Adjustments...p. 7 Polyethylene Glycol (PEG)... p. 8 Polyvinylpyrrolidone (PVP, povidone)... p. 8 Coatings Cellulose Acetate... p. 9 Fillers/Sweeteners Sugar Alcohols... pp. 0- Solubilizers/Surfactants Polysorbate 80 (TWEEN 80)... p. Residual Solvents USP <467> Class,, & 3... pp. 3-4 Ordering Information GC Solutions...p. 5 LC Solutions... pp Phenomenex, Inc. All rights reserved. 3

4 WHAT AND WHY? What are excipients? Excipients are the inactive ingredients within a pharmaceutical formulation that hold the active pharmaceutical ingredient (API) and ensure the conveniently sized dose is delivered efficiently and effectively to the targeted area. Excipients are typically inert substances, but sometimes they can result in adverse side effects. Modern pharmaceutical regulations require formulation analysis for all ingredients within a pharmaceutical drug to identify all excipient components and guarantee safety of the end product. Formulation analysis can be achieved through several modes of chromatography including reversed phase, ion-exclusion, size exclusion chromatography (SEC), which includes gel permeation chromatography (GPC) and gel filtration chromatography (GFC), and gas chromatography (GPC). Phenomenex offers a wide breadth of products for reliable and reproducible excipient analysis. Recommended Chromatography Technique by Excipient Category Excipient Binders Coatings Fillers / Sweeteners Solubilizers / Surfactants Residual Solvents Technique Size Exclusion Chromatography (SEC) Reversed Phase Ion-Exchange Gas Chromatography (GC) Size Exclusion Chromatography (SEC) Reversed Phase Ion-Exclusion/Ligand Exchange Reversed Phase Size Exclusion Chromatography (SEC) Gas Chromatography (GC) Gas Chromatography (GC) Phenomenex Premier Solutions by Technique HPLC/UHPLC Size Exclusion Chromatography (SEC) Gel Permeation Chromatography (GPC) Polymer-Based Non-Aqueous GPC/SEC Gel Filtration Chromatography (GFC) Silica-Based Aqueous GFC/SEC Polymer-Based Aqueous GFC/SEC Ion-Exclusion/Ligand Exchange Reversed Phase Ion-Exchange Recommended Phenogel Yarra (.8 µm, 3 µm), BioSep (5 µm) PolySep Rezex Kinetex (.3 µm,.7 µm,.6 µm, 3.5 µm, 5 µm) Luna (.6 µm,.5 µm, 3 µm, 5 µm) Luna SCX GC Gas Chromatography Recommended Zebron ZB-ms, ZB-5ms, ZB-5MSplus, ZB-35, ZB-50, ZB-64, ZB-WAXplus, ZB-FFAP 4 Phenomenex l WEB:

5 Pharmacopoeia Classifications Ph. Eur. Recommendations Column recommendations provided by the European Pharmacopoeia (Ph. Eur.) are generally given as a description of the media along with the column dimensions. For instance, a monograph may call for a stainless steel column 0.3 m long and 7.8 mm in internal diameter packed with strong cation-exchange resin (calcium form) R (9 µm) and maintained at a temperature of 85 ± C. This would be the precise description of our Rezex RCM-Monosaccharide 300 x 7. 8 mm column (P/N 00H-030-K0). WHAT AND WHY? Description According to Pharm. Eur Reagents 06 Number Recommended Phenomenex Column Silica gel for chromatography Kinetex HILIC Luna Silica() Silica gel for chromatography, alkyl bonded for use with highly aqueous mobile phases. Silica gel for chromatography, alkyl bonded for use with highly aqueous mobile phases, endcapped. Silica gel for chromatography, butylsilyl. Spheroidal 300 Å; pore volume: 0.6 cm3/g; area: 80 m/g Synergi Hydro-RP Synergi Fusion-RP Gemini C8 Gemini NX-C8 Kinetex C8 Kinetex EVO C8 Kinetex XB-C Synergi Hydro-RP Synergi Fusion-RP Gemini C8 Gemini NX-C8 Kinetex C8 Kinetex EVO C8 Kinetex XB-C8 Indicated Particle Size (µm) 3 to Aeris WIDEPORE C4 3 to 0 Silica gel for chromatography, butylsilyl, endcapped Aeris WIDEPORE C4 Jupiter 300 C4 Silica gel for chromatography, cyanosilyl Luna CN (Cyano) 3 to 0 Silica gel for chromatography, di-isobutyloctadecylsilyl Kinetex XB-C8 Silica gel for chromatography, diol dihydroxypropyl, 00 Å Luna HILIC 5 Silica gel for chromatography, dodecylsilyl, endcapped Synergi Max-RP 3 to 0 See More 5

6 WHAT AND WHY? Pharmacopoeia Classifications Description According to Pharm. Eur Reagents 06 Number Silica gel for chromatography, hydrophilic surface has been modified to provide hydrophilic characteristics. Recommended Phenomenex Column Indicated Particle Size (µm) Luna HILIC 3 to 0 Silica gel for chromatography, nitrile cyanopropylsilyl Luna CN (Cyano) 3 to 0 Silica gel for chromatography, nitrile R chemically bonded nitrile groups Luna CN (Cyano) 3 to 0 Silica gel for chromatography, nitrile R ultrapure silica (<0 ppm metal) with cyanopropylsilyl groups Luna CN (Cyano) 3 to 0 Silica gel for chromatography, nitrile, endcapped with cyanopropylsilyl groups Luna CN (Cyano) 3 to 0 Silica gel for chromatography, octadecylsilyl Luna C8() Synergi Hydro-RP Synergi Fusion-RP Gemini C8 Gemini NX-C8 Kinetex C8 Kinetex EVO C8 Kinetex XB-C8 Silica gel for chromatography, octadecylsilyl R ultrapure silica (<0 ppm metals), pore size and C-load are indicated in the method. Silica gel for chromatography, octadecylsilyl, base-deactivated pretreated before the bonding by careful washing and hydrolyzing most of the superficial siloxane bridges to minimize the interaction with basic components. Silica gel for chromatography, octadecylsilyl, endcapped. To minimize any interaction with basic compounds it s carefully endcapped to cover most of the remaining silanol groups. Silica gel for chromatography, octadecylsilyl, endcapped R ultrapure silica (<0 ppm metal), 9 % C-load. To minimize any interaction with basic compounds it s carefully endcapped to cover most of the remaining silanol groups. Silica gel for chromatography, octadecylsilyl, endcapped, base-deactivated; pore size 00 Å, C-load:6 %, pretreated before the bonding by careful washing and hydrolyzing most of the superficial siloxane bridges. To further minimize any interaction with basic compounds it s carefully endcapped to cover most of the remaining silanol groups. Silica gel for chromatography, octadecylsilyl, endcapped, base-deactivated R; pretreated before the bonding by careful washing and hydrolyzing most of the superficial siloxane bridges. To further minimize any interaction with basic compounds it s carefully endcapped to cover most of the remaining silanol groups. 000 Luna C8() Synergi Hydro-RP Synergi Fusion-RP Gemini C8 Gemini NX-C8 Jupiter C8 Kinetex C8 Kinetex EVO C8 Kinetex XB-C Luna C8() Gemini C8 Gemini NX-C8 Kinetex C8 Kinetex EVO C8 Kinetex XB-C Luna C8() Gemini C8 Gemini NX-C8 Kinetex C8 Kinetex EVO C8 Kinetex XB-C8 540 Luna C8 Synergi Hydro-RP Luna C8() Gemini C8 Gemini NX-C Luna C8() Gemini C8 Gemini NX-C8 Kinetex C8 Kinetex EVO C8 Kinetex XB-C8 3 to 0 3 to 0 3 to 0 3 to 0 3 to 0 3 to 0 6 Phenomenex l WEB:

7 Pharmacopoeia Classifications Description According to Pharm. Eur Reagents 06 Number Silica gel for chromatography, octadecylsilyl, monolithic Onyx C8 Silica gel for chromatography, octadecylsilyl, with polar embedded groups, endcapped; the particles are based on a mixture of silica chemically modified at the surface by the bonding of octadecylsilyl groups and silica chemically modified with a reagent providing a surface with chains having embedded polar groups. Silica gel for chromatography, octadecylsilyl, with polar incorporated groups, endcapped; the particles are based on silica, chemically modified with a reagent providing a surface with chains having polar incorporated groups and terminating octadecyl groups. Silica gel for chromatography, octadecylsilyl, ethylene-bridged (hybrid material). Synthetic, spherical ethylene-bridged particles, containing both organic and inorganic (silica) components. Silica gel for chromatography compatible with 00 % aqueous mobile phase, octadecylsilyl, endcapped. Silica gel for chromatography, octadecylsilyl, extra-dense bonded, endcapped. Silica gel for chromatography, octadecylsilyl, solid core, endcapped with spherical silica particles containing a non-porous solid silica core surrounded by a thin outer porous silica coating with octadecylsilyl groups. To minimize any interaction with basic compounds it is carefully endcapped to cover most of the remaining silanol groups. Recommended Phenomenex Column Indicated Particle Size (µm) Synergi Fusion-RP 3 to Synergi Fusion-RP 3 to Kinetex EVO C8 Gemini NX-C Kinetex EVO C8 Synergi Hydro-RP Synergi Fusion-RP Luna C8() Gemini C8 Gemini NX-C8 Kinetex C8 Kinetex EVO C8 Kinetex XB-C Kinetex C8 Kinetex XB-C8 Kinetex EVO C8 Aeris PEPTIDE XB-C8 Aeris WIDEPORE XB-C8 Silica gel for chromatography, octylsilyl Kinetex C8 Luna C8() Silica gel for chromatography, octylsilyl R. Bonding of octylsilyl and methyl groups (double bonded phase). Silica gel for chromatography, octylsilyl, base-deactivated pretreated before the bonding by careful washing and hydrolyzing most of the superficial siloxane bridges to minimize the interaction with basic components. Silica gel for chromatography, octylsilyl, endcapped. To minimize any interaction with basic compounds it s carefully endcapped to cover most of the remaining silanol groups. Silica gel for chromatography, octylsilyl, endcapped, base-deactivated pretreated before the bonding by careful washing and hydrolyzing most of the superficial siloxane bridges to minimize the interaction with basic components. To further minimize any interaction with basic compounds it s carefully endcapped to cover most of the remaining silanols Kinetex C8 Luna C8() 3600 Kinetex C8 Luna C8() 9600 Kinetex C8 Luna C8() Kinetex C8 Luna C8() Silica gel for chromatography, phenylhexylsilyl Kinetex Phenyl-Hexyl Luna Phenyl-Hexyl Gemini C6-Phenyl Silica gel for chromatography, phenylhexylsilyl, endcapped 3 µm. To minimize any interaction with basic compounds it s carefully endcapped to cover most of the remaining silanol groups Kinetex Phenyl-Hexyl Luna Phenyl-Hexyl Gemini C6-Phenyl Silica gel for chromatography, phenylsilyl. 000 Synergi Polar-RP Luna Phenyl-Hexyl Gemini C6-Phenyl Kinetex Biphenyl Kinetex Phenyl-Hexyl 3 to 0 3 to 0 3 to 0 3 to 0 3 to 0 3 to to 0 WHAT AND WHY? See More 7

8 WHAT AND WHY? Pharmacopoeia Classifications Description According to Pharm. Eur Reagents 06 Number Silica gel for chromatography, phenylsilyl, endcapped. To minimize any interaction with basic compounds it s carefully endcapped to cover most of the remaining silanol groups. Recommended Phenomenex Column Synergi Polar-RP Luna Phenyl-Hexyl Gemini C6-Phenyl Kinetex Biphenyl Kinetex Phenyl-Hexyl Indicated Particle Size (µm) Silica gel for chromatography, propoxybenzene, endcapped Synergi Polar-RP 3 to 0 Silica gel for chromatography, strong cation-exchange bonding of sulfonic acid groups. Silica for size-exclusion chromatography. 0 µm silica with a very hydrophilic surface. Pore size average: 30 nm; ph stability to 8; exclusion range for proteins: x 0 3 to 3 x 0 5. Organosilica polymer, amorphous, octadecylsilyl. Synthetic, spherical hybrid particles containing both inorganic (silica) and organic (organosiloxanes) components, chemically modified at the surface by trifunctionally bonded octadecylsilyl groups. Organosilica polymer, amorphous, octadecylsilyl, endcapped. Synthetic, spherical hybrid particles containing both inorganic (silica) and organic (organosiloxanes) components, chemically modified at the surface by trifunctionally bonded octadecylsilyl groups. To minimize any interaction with basic compounds, it is carefully endcapped to cover most of the remaining silanol groups. Organosilica polymer for mass spectrometry, amorphous, octadecylsilyl, endcapped. Synthetic, spherical hybrid particles containing both inorganic (silica) and organic (organosiloxanes) components. To minimize any interaction with basic compounds, it is carefully endcapped to cover most of the remaining silanol groups. Ion-exclusion resin for chromatography. A resin with sulfonic acid groups attached to a polymer lattice consisting of polystyrene cross-linked with divinylbenzene. Cation-exchange resin, strong. Strong cation-exchange resin in protonated form with sulfonic acid groups attached to a polymer lattice consisting of polysterene cross-linked with divinylbenzene. Cation-exchange resin (Calcium form), strong. Resin in calcium form with sulfonic acid groups attached to a polymer lattice consisting of polystyrene cross-linked with 8 % divinylbenzene Cation-exchange resin (Sodium form), strong. Resin in sodium form with sulfonic acid groups attached to a polymer lattice consisting of polystyrene cross-linked with divinylbenzene. 5 to Luna SCX 5 to BioSep -SEC-S Kinetex EVO C8 Gemini C8 Gemini NX-C Kinetex EVO C8 Gemini C8 Gemini NX-C Kinetex EVO C8 Gemini C8 Gemini NX-C Rezex ROA-Organic Acid Rezex RHM-Monosaccharide Rezex ROA-Organic Acid Rezex RHM-Monosaccharide Rezex RCM-Monosaccharide Rezex RCU-USP Sugar Alcohols 7600 Rezex RNM-Carbohydrate 8 Phenomenex l WEB:

9 Pharmacopoeia Classifications USP Packings (L classifications) USP Column Classification L Octadecyl silane chemically bonded to porous or non-porous silica or ceramic microparticles,.5 to 0 μm in diameter, or a monolithic rod. Recommended Phenomenex Column Gemini NX-C8 Kinetex C8 Kinetex EVO C8 Kinetex XB-C8 Luna C8() Gemini C8 Synergi Hydro-RP Synergi Fusion-RP L3 Porous silica particles,.5 to 0 μm in diameter, or a monolithic silica rod. Kinetex HILIC Luna Silica() Onyx Silica L7 Octyl silane chemically bonded to totally or superficially porous silica particles,.5 to 0 μm in diameter, or a monolithic silica rod. Kinetex C8 Luna C8() Onyx C8 Particle Shape Core-Shell Core-Shell Core-Shell Core-Shell Monolith Core-Shell Monolith WHAT AND WHY? L8 L9 L0 L L7 An essentially monomolecular layer of aminopropyl-silane chemically bonded to totally porous silica gel support,.5 to 0 μm in diameter, or a monolithic silica rod. Irregular or spherical, totally porous silica gel having a chemically bonded, strongly acidic cation-exchange coating, 3 to 0 µm in diameter. Nitrile groups chemically bonded to porous silica particles,.5 to 0 μm in diameter, or a monolithic silica rod. Phenyl groups chemically bonded to porous silica particles,.5 to 0 μm in diameter, or a monolithic silica rod. Strong cation-exchange resin consisting of sulfonated cross-linked styrene-divinylbenzene copolymer in the hydrogen form, 6 to μm in diameter. Luna NH Luna SCX Aeris WIDEPORE XB-C8 Luna CN 00 Å Kinetex Biphenyl Kinetex Phenyl-Hexyl Synergi Polar-RP Luna Phenyl-Hexyl Gemini C6-Phenyl Prodigy PH-3 Rezex RHM-Monosaccharide Rezex ROA-Organic Acid Core-Shell Core-Shell Core-Shell L9 L0 Strong cation-exchange resin consisting of sulfonated cross-linked styrene-divinylbenzene copolymer in the calcium form, 5 to 5 μm in diameter. Dihydroxypropane groups chemically bonded to porous silica or hybrid particles,.5 to 0 μm in diameter, or a monolithic silica rod. Rezex RCM-Monosaccharide Rezex RCU-Sugar Alcohols Luna HILIC BioSep -SEC-S L A rigid, spherical styrene-divinylbenzene copolymer, 3 to 30 μm in diameter. L A cation-exchange resin made of porous polystyrene gel with sulfonic acid groups, 5 to 5 μm in diameter. PolymerX RP- Phenogel 00 Å Rezex ROA-Organic Acid Yarra SEC L6 Butyl silane chemically bonded to totally porous silica particles,.5 to 0 μm in diameter. Jupiter 300 C4 Aeris WIDEPORE C4 Core-Shell 9

10 WHAT AND WHY? Pharmacopoeia Classifications USP Packings (L classifications cont d) USP Column Classification L33 L34 L35 L37 Recommended Phenomenex Column Yarra SEC-000 Packing having the capacity to separate dextrans by molecular size over a range of 4,000 to 500,000 daltons. It is spherical, silica-based and processed to provide ph stability. BioSep -SEC-S000 Yarra SEC-3000 BioSep-SEC-S3000 Strong cation-exchange resin consisting of sulfonated cross-linked styrene-divinylbenzene copolymer in the lead form, 7 to 9 μm in diameter. A zirconium-stabilized spherical silica packing with a hydrophilic (diol-type) molecular monolayer bonded phase having a pore size of 50 Å. Polymethacrylate gel packing having the capacity to separate proteins by molecular size over a range of,000 to 40,000 daltons. Rezex RPM-Monosaccharide (BioSep-SEC-S000 or Yarra SEC-000 may be used) PolySep -GFC-P3000 Particle Shape L38 Methacrylate-based size-exclusion packing for water-soluble samples. PolySep-GFC-P series L39 Hydrophilic polyhydroxymethacrylate gel of totally porous spherical resin. PolySep-GFC-P series L43 Pentafluorophenyl groups chemically bonded to silica particles by a propyl spacer,.5 to 0 μm in diameter. Kinetex F5 Luna PFP() Core-Shell L58 Strong cation-exchange resin consisting of sulfonated cross-linked styrene-divinylbenzene copolymer in the sodium form, about 6 to 30 μm in diameter. Rezex RNM-Carbohydrate L59 Size-exclusion separations of proteins (separation by molecular weight) over the range of 5 to 7000 kda. (.5 to 0 μm), silica or hybrid packing with a hydrophilic coating. Yarra SEC-000 BioSep-SEC-S000 Yarra SEC-3000 BioSep-SEC-S3000 USP Phase Designation (G classifications) Phase Type Phase Description Recommended Zebron GC Columns G Dimethylpolysiloxane Oil ZB-, ZB-ms, ZB-HT Inferno G Dimethylpolysiloxane Gum ZB-, ZB-ms, ZB-HT G3 50 % Phenyl 50 % Methylpolysiloxane ZB-50 G9 Methylvinylpolysiloxane ZB-ms, ZB-HT Inferno, ZB- G4 Polyethylene Glycol (Average MW 950 -,050) ZB-WAX, ZB-WAXplus G5 Polyethylene Glycol (Average MW 3,000-3,700) ZB-WAX, ZB-WAXplus G6 Polyethylene Glycol (Average MW 5,000) ZB-WAX, ZB-WAXplus G7 75 % Phenyl 5 % Methylpolysiloxane ZB-50 G0 Polyethylene Glycol (Average MW ) ZB-WAX, ZB-WAXplus G5 Polyethylene Glycol TPA (Carbowax 0M Terepthalic Acid) ZB-FFAP G7 5 % Phenyl 95 % Methylpolysiloxane ZB-5, ZB-5MSi, ZB-5HT Inferno 5 % Phenyl-Arylene 95 % Methylpolysiloxane ZB-5ms, ZB-5MSplus, ZB-SemiVolatiles G8 5 % Phenyl 75 % Methylpolysiloxane ZB-35, ZB-35HT Inferno G3 0 % Phenylmethyl 80 % Dimethylpolysiloxane ZB-35, ZB-35HT Inferno G35 Polyethylene Glycol / Diepoxide Esterified with Nitroterepthalic Acid ZB-FFAP G36 % Vinyl 5 % Phenylmethylpolysiloxane ZB-5, ZB-5MSi, ZB-5HT Inferno G38 Phase G / Small % Tailing Inhibitor ZB-, ZB-ms, ZB-HT Inferno G39 Polyethylene Glycol (Average MW,500) ZB-WAX, ZB-WAXplus G4 Phenylmethyldimethylsilicone (0 % Phenyl Substituted) ZB-5, ZB-5MSi, ZB-5HT Inferno G4 35 % Phenyl 65 % Dimethylpolysiloxane ZB-35, ZB-35HT Inferno G43 6 % Cyanopropylphenyl 94 % Dimethylpolysiloxane ZB-64 G46 4 % Cyanopropylphenyl 86 % Methylpolysiloxane ZB-70, ZB-70P G47 Polyethylene Glycol (Average MW 8,000) ZB-WAXplus, ZB-WAX 0 Phenomenex l WEB:

11 Allowable Adjustments Recent revisions of both the USP and Ph. Eur. have better defined the allowable adjustments one can make to an existing monograph without requiring revalidation. Below are the isocratic and gradient summaries for the ranges of these parameter changes, or prohibition thereof. Allowable Adjustments to Pharmacopoeia Methods for Isocratic Separations Component United States Pharmacopoeia (USP) European Pharmacopoeia (Ph. Eur.) Mobile phase minor component ( 50 %) ± 30 % Relative; Cannot exceed ± 0 % Absolute change; Cannot be reduced to zero ± 30 % Relative or ± % absolute, whichever is the larger; Cannot exceed ± 0 % Absolute change Mobile phase ph ± 0. ph units ± 0. ph units; ±.0 for non-ionizable substances Buffer concentration ± 0 % ± 0 % Column temperature ± 0 C ± 0 C Injection volume Can be adjusted as much as needed; must be consistent with linearity, precision, and detection reqs. Can be reduced so long as precision and detection limits are met Detector wavelength Cannot be modified Cannot be modified Flow rate ± 50 % (at given ID) ± 50 % (at given ID; flow rates may be adjusted more when changing inner diameter) Column inner Can be adjusted so long as linear velocity is maintained ± 5 % diameter Column length Column length (L) to particle size diameter (dp) ratio can be Column length may be adjusted ± 70 % adjusted between -5 % and +50 % * Particle size Column length (L) to particle size diameter (dp) ratio can be Particle diameter may be reduced as much as 50 % adjusted between -5 % and +50 % * Stationary phase No change of the identity of the substituent permitted No change of the identity of the substituent permitted Guards Same stationary phase as column; guard ID column ID; guard length 5 % column length There is no statement not allowing guard columns as long as it has same material as the column * Alternatively (as for the application of particle size adjustment to superficially porous particles), other L/dp combinations can be used provided that the number of theoretical plates (N) is within -5% to +50 % WHAT AND WHY? Allowable Adjustments to Pharmacopoeia Methods for Gradient Separations Component United States Pharmacopoeia (USP) European Pharmacopoeia (Ph. Eur.) Mobile phase minor component ( 50 %) Changes to gradient composition are not recommended Minor adjustments of the composition of the mobile phase and the gradient are acceptable, if the system suitability requirements are met, the principle peak(s) elute(s) within ± 5 % of the indicated retention time(s) and the final elution power of the mobile phase is not weaker. Mobile phase ph ± 0. ph units No adjustment permitted Buffer concentration ± 0 % No adjustment permitted Column temperature ± 0 C ± 5 C Injection volume Can be adjusted as much as needed; must be consistent with linearity, precision, and detection reqs. Can be reduced so long as precision and detection limits are met Detector wavelength Cannot be modified Cannot be modified Flow rate Changes to flow rate are not allowed Adjustment is permitted to maintain linear velocity when changing column dimensions Column inner Changes to column length, particle size, ± 5 % diameter or inner diameter are not allowed Column length Changes to column length, particle size, ± 70 % or inner diameter are not allowed Particle size Changes to column length, particle size, No change permitted or inner diameter are not allowed Stationary phase No change of the identity of the substituent permitted No change of the identity of the substituent permitted Guards Same stationary phase as column; guard ID column ID; guard length 5 % column length There is no statement not allowing guard columns as long as it has same material as the column To view the latest updates, please visit:

12 BINDERS Binders Binders are the most extensively used excipient and are typically polymers that hold all of the ingredients together. A major benefit of binders is the addition of mechanical strength to the tablet to ensure rigid shape, high stability, and long storage lifetimes. Binders can also be considered fillers when adding bulk to a tablet. Polyethylene Glycol (PEG) GPC separation of a polyethylene glycol (PEG) standard using 3 fixed pore size Phenogel columns (50 Å, 00 Å, and 500 Å) and THF mobile phase at ml/ min. Fixed pore size columns can provide increased resolution of narrower MW ranges compared to the mixed bed linear phases. Note that discrete MW species can be resolved. Column: Phenogel 5 µm 50 Å, 00 Å, 500 Å Dimensions: 300 x 7.8 mm Mobile Phase: THF Flow Rate: ml/min Detection: Refractive Index (RI) Temperature: 40 C Sample:. PEG 300 nriu min App ID 506 GPC separation of an Advil Cold & Sinus LIQUI-GELS sample. Note the corresponding peaks to API as peak 3, PEG as peak, and a larger disperse polymer (i.e., gelatin) as peak. The combination of the 3 fixed pore size Phenogel columns (50 Å, 00 Å, and 500 Å) in series can give a slightly wider range than one specific fixed pore size column. Column: Phenogel 5 µm 50 Å, 00 Å, 500 Å Dimensions: 300 x 7.8 mm Mobile Phase: THF Flow Rate: ml/min Detection: Refractive Index (RI) Temperature: 40 C Sample:. API Unknown Peak A. PEG API Unknown Peak B nriu Polyvinylpyrrolidone (PVP, Povidone) Separation of polyvinylpyrrolidone (povidone) on x Phenogel Linear() column using DMF as mobile phase. Povidone is a common binder and filler agent used in tablet formulations. Note the wide MW distribution on a GPC column. Column: Phenogel 5 µm Linear() x Dimensions: 300 x 7.8 mm Part No.: 00H-359-K0-DF Mobile Phase: 0 mm Lithium Bromide in DMF Flow Rate: ml/min Detection: Refractive Index (RI) Temperature: 40 C Sample:. Polyvinylpyrrolidone (PVP) nriu min min App ID 505 App ID 507 Phenomenex l WEB:

13 Coatings Polymer coatings on pharmaceuticals help seal the drug, prevent dissolution, and enable drug targeting. Some coatings can also facilitate a delayed dosage for an accurately timed release of the active ingredient. COATINGS Cellulose Acetate GPC separation of cellulose acetate using x Phenogel Linear() columns. Cellulose acetate is also used as a binder for tablets and is very polydisperse leading to a very broad peak. Mixed bed linear phases are well suited for wide MW distribution separations. nriu App ID min Column: Phenogel 5 µm Linear() x Dimensions: 300 x 7.8 mm Part No.: 00H-359-K0-DF Mobile Phase: 0 mm Lithium Bromide in DMF Flow Rate: ml/min Detection: Refractive Index (RI) Temperature: 40 C Sample:. Cellulose acetate 3

14 FILLERS/SWEETENERS Fillers/Sweeteners As the name implies, fillers bulk up a tablet or capsule in order to make it a suitable size for manufacturing, packaging, and ingestion. Many fillers are coupled as sweeteners to combat the bitter taste of other active and non-active ingredients. Sugar Alcohols Optimizing Pharmacopoeia (Ph. Eur. & USP) Monographs of Sugar Alcohol Excipients Using Rezex Ion-Exclusion HPLC Columns Rezex ion-exclusion HPLC columns are the solution for several published European Pharmacopoeia (Ph. Eur.) and United States Pharmacopoeia (USP) methodologies, particularly for excipients like sugar alcohols such as sorbitol, mannitol, isomalt, maltilol, lactitol, xylitol, trehalose, erythritol, etc. The Rezex RCM/RCU phases contain the strong cationexchange resin (calcium form), or L9 USP packing, that is recommended by most pharmacopoeia monographs for sugar alcohols, while the Rezex RPM (lead form), or L34 USP packing, will provide stronger separation power. In this example, we study a mixture of 7 sugar alcohols whose monographs typically call for a column with calcium form, or L9 packing. A Bio- Rad Aminex HPX-87C is commonly recommended, however, the direct replacement, Rezex RCM, provides sharper peak shape and higher resolution as shown by the comparison below. As an excellent alternative, Rezex RPM provides stronger retention and higher resolution of the more closely eluting peaks compared to Rezex RCM. Rezex RCM vs. Aminex HPX-87C mau mau mau Rezex RCM Aminex HPX-87C Rezex RPM App ID 3468 min App ID 347 min App ID 3470 min Column Cross Reference Chart Phenomenex Rezex Bio-Rad Aminex RCM-Monosaccharide HPX-87C RHM-Monosaccharide HPX-87H RPM-Monosaccharide HPX-87P RNM-Carbohydrate HPX-87N RSO-Oligosaccharide HPX-4A ROA-Organic Acid HPX-87H RFQ-Fast Acid Fast Acid RKP-Potassium HPX-87K 5-04 RCU-USP Sugar Alcohols Sugar Alcohols Conditions for all columns: Dimensions: 300 x 7.8 mm Mobile Phase: Water Flow Rate: 0.6 ml/min Detection: ELSD Temperature: 85 C Sample:. Trehalose. Isomalt 3. Maltilol 4. Isomaltilol 5. Mannitol 6. Xylitol 7. Sorbitol Comparative separations may not be representative of all applications. 4 Phenomenex l WEB:

15 Separation of a Complex Mixture of Sugar Alcohols on Rezex RPM-Monosaccharide A mixture of sugars and sugar alcohols run on a Rezex RPM 300 x 7.8 mm column. Note the wide separation between Mannitol (8), Xylitol (0) and Sorbitol () App ID 5508 Reduce Analysis Times Using Shorter Rezex RPM-Monosaccharide A mixture of mannitol () and sorbitol () run on a Rezex RPM- Monosaccharide 00 x 7.8 mm column using similar conditions to the USP method. Note the reduced run time of 5 minutes for separating the two excipients. App ID 550 FILLERS/SWEETENERS min min Column: Rezex RPM-Monosaccharide Dimensions: 300 x 7.8 mm Part No.: 00H-035-K0 Mobile Phase: Water Flow Rate: 0.6 ml/min Detection: RI (Ambient) Column Temperature: 75 C Sample:. Stachyose. Maltose 3. Glucose 4. Xylose 5. Galactose 6. Fructose 7. Meso-Erythritol 8. Mannitol 9. Salicin 0. Xylitol. Sorbitol Column: Rezex RPM-Monosaccharide Dimensions: 00 x 7.8 mm Part No.: 00D-035-K0 Mobile Phase: Water Flow Rate: 0.6 ml/min Detection: ELSD (Ambient) Column Temperature: 80 C Sample:. Mannitol. Sorbitol Alternative Selectivity of Rezex RCM-Monosaccharide Phase Offers A mixture of sugars and sugar alcohols run on a Rezex RCM- Monosaccharide 300 x 7.8 mm column. Note the different retention times for compounds, despite using similar column dimensions and flow rates. Rezex RCM offers different selectivity versus the Rezex RPM column. Rezex RCU-USP Sugar Alcohols: Well Suited for Published USP Methodologies A mixture of () mannitol and () sorbitol run on a Rezex RCU-USP Sugar Alcohols 50 x 4.0 mm column using a method similar to the published USP method. The Rezex RCU offers a different option for the Mannitol and Sorbitol application App ID 4977 App ID min 0 4 min Column: Rezex RCM-Monosaccharide Dimensions: 300 x 7.8 mm Part No.: 00H-030-K0 Mobile Phase: Water Flow Rate: 0.6 ml/min Detection: ELSD (Ambient) Column Temperature: 80 C Sample:. Sucrose. Glucose 3. Galactose 4. Fructose 5. Sorbitol Column: Rezex RCU-USP Sugar Alcohols Dimensions: 50 x 4.0 mm Part No.: 00G-030-D0 Mobile Phase: Water Flow Rate: 0. ml/min Detection: RI (Ambient) Column Temperature: 85 C Sample:. Mannitol. Sorbitol 5

16 SOLUBILIZERS/SURFACTANTS Solubilizers/Surfactants In order to ensure solubility of an API in various forms such as tablets, vaccines, and intravenous preparations, solubilizers are added to the excipient formulation. They can also be helpful for the dissolution of a tablet after ingestion. Polysorbate 80 (Tween 80) HPLC-UV Analysis on a Yarra.8 µm SEC-X50 Aqueous GFC/SEC Column Polysorbate 80, also known as TWEEN 80, is very popular in the pharmaceutical, food, and cosmetic industries as an excipient, or inactive ingredient, in products such as tablets, vaccines, intravenous preparations, lotions, and soaps. The primary role of this pharmaceutical excipient is a solubilizing agent acting as a surfactant to assist with the solubility of all other pharmaceutical ingredients and also dissolution of the tablet. In this application, TWEEN 80 is analyzed by HPLC-UV using a Yarra.8 µm SEC-X50 50 x 4.6 mm aqueous size exclusion (SEC), or gel filtration chromatography (GFC), column in under minutes. mau 4 App ID min LC/UV Conditions Column: Yarra.8 µm SEC-X50 Dimensions: 50 x 4.6 mm Part No.: 00F-463-E0 Mobile Phase: Water/Acetonitrile (65:35) Flow Rate: 0.4 ml/min Temperature: Ambient Detection: 45 nm Sample: TWEEN 80 6 Phenomenex l WEB:

17 Residual Solvents Residual solvents are trace-level chemical residues in drug substances and drug products that are byproducts of manufacturing, or that form during packaging and storage. It is the responsibility of the drug manufacturers to ensure that these residues are removed, or are present only in limited concentrations. USP Monograph <467> In 008, the United States Pharmacopoeia (USP) revised the general chapter on residual solvent analysis, USP <467>, to reflect the International European Pharmacopoeia (Ph. Eur.) guidelines for the identification, control and quantification of residual solvents. This revision significantly increased the requirements a pharmaceutical company must meet in order to demonstrate that all drug products (not just new) are compliant with Chapter <467> limits. RESIDUAL SOLVENTS Procedure A Class Procedure A Class Mix A App ID App ID min GC/FID Conditions Column: Zebron ZB-64 Dimensions: 30 meter x 0.3 mm x.80 µm Part No.: 7HM-G005-3 Injection: Headspace 40 C, ml Carrier Gas: 35 cm/sec (constant flow) Oven Program: 40 C for 0 min to 40 0 C/min for 0 min Detector: 50 C Sample: Sample prepared as per USP guidelines.,-dichloroethene.,,-trichloroethane 3. Carbon tetrachloride Procedure A Class Mix B 4. Benzene 5.,-Dichloroethane min GC/FID Conditions Column: Zebron ZB-64 Dimensions: 30 meter x 0.3 mm x.80 µm Part No.: 7HM-G005-3 Injection: Headspace 40 C, ml Carrier Gas: 35 cm/sec (constant flow) Oven Program: 40 C for 0 min to 40 0 C/min for 0 min Detector: 50 C Sample: Sample prepared as per USP guidelines.methanol. Acetonitrile 3. Dichloromethane 4. cis-,-dichloroethene 5. THF 6. Cyclohexane 7. Methylcyclohexane 8.,4-Dioxane 9. Toluene 0. Chlorobenzene. Ethylbenzene. m-xylene 3. p-xylene 4. o-xylene App ID min GC/FID Conditions Column: Zebron ZB-64 Dimensions: 30 meter x 0.3 mm x.80 µm Part No.: 7HM-G005-3 Injection: Headspace 40 C, ml Carrier Gas: 35 cm/sec (constant flow) Oven Program: 40 C for 0 min to 40 0 C/min for 0 min Detector: 50 C Sample: Sample prepared as per USP guidelines. Hexane. Nitromethane 3. Chloroform 4.,-Dimethoxyethane 5. Trichloroethylene 6. Pyridine 7. Methylbutylketone 8. Tetralin 7

18 RESIDUAL SOLVENTS Residual Solvents USP Monograph <467> Procedure B Class 4, 3 5 App ID 635 Procedure B Class Mix A App ID min GC/FID Conditions Column: Zebron ZB-WAXPLUS Dimensions: 30 meter x 0.3 mm x 0.5 µm Part No.: 7HM-G03- Injection: Headspace 40 ºC, ml Carrier Gas: 35 cm/sec (constant flow) Oven Program: 50 ºC hold 0 min to 65 6 ºC/min hold 0 min Detector: 50 C Sample: Sample prepared as per USP method.,-dichloroethene. Carbon tetrachloride 3.,,-Trichloroethane 4. Benzene 5.,-Dichloroethane min GC/FID Conditions Column: Zebron ZB-WAXPLUS Dimensions: 30 meter x 0.3 mm x 0.5 µm Part No.: 7HM-G03- Injection: Headspace 40 ºC, ml Carrier Gas: 35 cm/sec (constant flow) Oven Program: 50 ºC hold 0 min to 65 6 ºC/min hold 0 min Detector: 50 C Sample: Sample prepared as per USP method. Cyclohexane. Methylcyclohexane 3. THF 4. Methanol 5. Dichloromethane 6. cis-,-dichloroethene 7. Acetonitrile 8. Toluene 9.,4-Dioxane 0. Ethylbenzene. p-xylene. m-xylene 3. o-xylene 4. Chlorobenzene Procedure B Class Mix B Procedure B Class Mix C App ID 6354 App ID min GC/FID Conditions Column: Zebron ZB-WAXPLUS Dimensions: 30 meter x 0.3 mm x 0.5 µm Part No.: 7HM-G03- Injection: Headspace 40 ºC, ml Carrier Gas: 35 cm/sec (constant flow) Oven Program: 50 ºC hold 0 min to 65 6 ºC/min hold 0 min Detector: 50 C Sample: Sample prepared as per USP method. Hexane.,-Dimethoxyethane 3. Trichloroethylene 4. Chloroform 5. Methylbutylketone 6. Nitromethane 7. Pyridine 8. Tetralin min GC/FID Conditions Column: Zebron ZB-WAXPLUS Dimensions: 30 meter x 0.3 mm x 0.5 µm Part No.: 7HM-G03- Injection: Headspace 40 ºC, ml Carrier Gas: 35 cm/sec (constant flow) Oven Program: 50 ºC hold 0 min to 65 6 ºC/min hold 0 min Detector: 50 C Sample: Sample prepared as per USP method. N,N-Dimethylformamide. N,N-Dimethylacetamide 8 Phenomenex l WEB:

19 GC (Gas Chromatography) GC Columns Zebron Phase ID (mm) df (μm) 0 meter 5 meter 30 meter 60 meter ZB-ms CB-G0-0 Very low bleed for GC/MS analyses; recommended CD-G0-08 for active compounds and boiling point separations HG-G EG-G0-7HG-G0-7KG-G HG-G HG-G0-7KG-G EM-G0-7HM-G HM-G0-7KM-G HK-G0- ZB-5ms CB-G00-0 Stable, low bleed 5 % phenyl-arylene phase for GC and GC/MS; CD-G00-08 recommended for a variety of pharmaceutical applications EG-G00-7HG-G00-7KG-G HG-G HG-G HM-G00-7KM-G HM-G HM-G00- ZB-5MSplus EG-G030-7HG-G030-7KG-G030- Highly inert 5 % phenyl-arylene phase for chemical, biological, HG-G030-7 and other pharmaceutical testing HG-G HM-G HM-G030- ZB EG-G003-7HG-G003-7KG-G003- Rugged, inert, intermediate polarity phase for versatile EG-G HG-G003-7 separations HM-G003-7KM-G HK-G EK-G003-7HK-G003- ZB EG-G Recommended for phenolic antioxidants and amino acids EG-G004-7HG-G004-7KG-G HG-G KG-G EM-G004-7HM-G EM-G HM-G EK-G004-7HK-G004- ZB HG-G KG-G005-7 Specifically designed for VOC separations, including OVIs and HM-G KM-G005-3 residual solvents HK-G KK-G ZB-WAXplus CB-G % aqueous stable with high retention of alcohols and EG-G03-7HG-G03-7KG-G03- chlorinated solvents; recommended for alcohols, flavors, and HM-G03-7KM-G03- residual solvent applications HM-G03-7 7KM-G EK-G03-7HK-G03-7KK-G03- ZB-FFAP EG-G009-7HG-G009-7KG-G009- High polarity nitroterephthalic acid modified PEG phase with EM-G009-7HM-G009- good peak shape for underivatized acids; especially suited for EM-G HM-G009-7 organic acids, free fatty acids, and alcohols HM-G EK-G009-7HK-G009- ORDERING INFORMATION Explore Tips and Tools Online: 9

20 ORDERING INFORMATION Gel Filtration (GFC) Yarra Column Specifications SEC-X50 SEC-000 SEC-3000 SEC-4000 Resin Type Silica Silica Silica Silica Particle Size (µm) Pore Size (Å) MW Range (Da) K-450K K-300K 5K-700K 5K-500K ph Range Typical Backpressure (psi) Max Backpressure (psi) Typical Efficiency Max. Flow Rate (ml/min) 3,50,300,300,000 7,000 3,000 3,000,700 > 30,000 (50 x 4.6 mm) 48,000 (300 x 7.8 mm) 48,000 (300 x 7.8 mm) 38,000 (300 x 7.8 mm) Ultra-High Efficiency GFC/SEC Yarra.8 µm SEC Column (mm) Analytical Phase 50 x µm SEC-X50 00F-463-E0 Yarra 3 µm SEC Columns (mm) Narrow Bore Analytical Analytical SecurityGuard Cartridges (mm) Phases 300 x x x x 3.0 * /0pk Yarra 3 µm SEC H-45-E0 00F-45-K0 00H-45-K0 AJ Yarra 3 µm SEC H-453-E0 00F-453-K0 00H-453-K0 AJ Yarra 3 µm SEC H-454-E0 00H-454-K0 AJ * SecurityGuard Analytical cartridges require holder, Part No.: KJ0-48 for ID mm Polymeric Gel Filtration (GFC) PolySep Technical Data and Specifications Phase Linear Exclusion Limits in Daltons: PEG Pullulans x x x 0 3 x x 0 4 x 0 5 x x 0 5 x x 0 6 x 0 7 x 0 7 x 0 7 x 0 7 Separation Range (Da) 0-3 K 00-0 K K 3 K K 50 K - M 00 K - 5 M K - 0 M Typical Efficiency Plates/meter,000 50,000 3,000 3,000 3,000 3,000 3,000 Maximum Organic Modifier: Methanol Acetonitrile 0 % 0 % 95 % 70 % 70 % 70 % 70 % 70 % ph Range 3.0 to.0 Maximum Flow Rate Column Hardware Temperature 4 to 60 C Maximum Salt Storage General 70 % 70 % Depends on backpressure, do not exceed 000 psi Stainless steel or PEEK (Biocompatible hardware available upon request) 70 % 70 % Maximum allowed 0.5 M with a flow rate not to exceed 0.5 ml/min For overnight, pump water at 0. ml/min, for longer storage use 0.05 % NaN 3 in water or 0 % methanol in water A guard column is recommended to improve column life 70 % 70 % PolySep Columns (mm) Analytical Guards Phases 300 x x CH0-96 CH CH0-97 CH CH0-98 CH CH0-99 CH CH0-930 CH CH0-93 CH0-95 Linear CH0-93 CH Phenomenex l WEB:

21 Ion-Exclusion/Ligand Exchange Rezex Columns Guards Part No. Gel Permeation (GPC) Phenogel Description Size (mm) Cross Linkage Ionic Form Organic GPC/SEC SecurityGuard Cartridges (mm) USP Packing Price Part No. Size (mm) Price 4 x 3.0 * (0pk) Price 00H-030-K0 RCM-Monosaccharide 300 x % Calcium L9 03B-030-K0 50 x 7.8 AJ F-030-K0 RCM-Monosaccharide 50 x % Calcium L9 03B-030-K0 50 x 7.8 AJ G-030-D0 RCU-USP Sugar Alcohols 50 x % Calcium L9 03A-030-D0 30 x 4.0 AJ H-035-K0 RPM-Monosaccharide 300 x % Lead L34 03B-035-K0 50 x 7.8 AJ D-035-K0 RPM-Monosaccharide 00 X % Lead L34 03B-035-K0 50 x 7.8 AJ0-449 for ID: mm * SecurityGuard Analytical Cartridges require universal holder Part No. KJ0-48 Ion Exclusion LC ORDERING INFORMATION Shipping Solvent SecurityGuard 5 μm Analytical Columns (mm) THF Chloroform DMF Cartridges (mm) Pore Size MW Range 300 x x x x 3.0 * /3pk 50 Å 00-3 K 00H-044-K0 00H-044-K0-CL 00H-044-K0-DF AJ Å K 00H-044-K0 00H-044-K0-CL 00H-044-K0-DF AJ Å K-5 K 00H-0443-K0 00H-0443-K0-CL 00H-0443-K0-DF AJ Å K-75 K 00H-0444-K0 00H-0444-K0-CL 00H-0444-K0-DF AJ Å 5 K-500 K 00H-0445-K0 00H-0445-K0-CL 00H-0445-K0-DF AJ Å 0 K-,000 K 00H-0446-K0 00H-0446-K0-CL 00H-0446-K0-DF AJ Å 60 K-0,000 K 00H-0447-K0 00H-0447-K0-CL 00H-0447-K0-DF AJ x x x x 3.0 * Mixed Beds /3pk Linear() 00-0,000 K 00H-359-K0 00H-359-K0-CL 00H-359-K0-DF AJ0-99 for mm ID SecurityGuard 5 μm Narrow Bore (NB) Columns (mm) Cartridges (mm) Pore Size MW Range 300 x x 3.0 * /3pk 50 Å 00-3 K 00H-044-E0 AJ Å K 00H-044-E0 AJ Å K-5 K 00H-0443-E0 AJ Å K-75 K 00H-0444-E0 AJ Å 5 K-500 K 00H-0445-E0 AJ Å 0 K-,000 K 00H-0446-E0 AJ Å 60 K-0,000 K 00H-0447-E0 AJ x x 3.0 * Mixed Beds /3pk Linear() 00-0,000 K 00H-359-E0 AJ0-99 for mm ID SecurityGuard 0 μm Analytical Columns (mm) Cartridges (mm) Pore Size MW Range 300 x x 3.0 * /3pk 50 Å 00-3 K 00H-064-K0 AJ Å K 00H-064-K0 AJ Å K-5 K 00H-0643-K0 AJ Å K-75 K 00H-0644-K0 AJ Å 5 K-500 K 00H-0645-K0 AJ Å 0 K-,000 K 00H-0646-K0 AJ Å 60 K-0,000 K 00H-0647-K0 AJ x x 3.0 * Mixed Beds /3pk Linear() 00-0,000 K 00H-360-K0 AJ0-99 for mm ID * SecurityGuard Analytical Cartridges require holder, Part No.: KJ0-48 Guard Cartridge Holder Part No. Description Price KJ0-48 Reusable Holder (SecurityGuard Kit) Column Union Part No. Description Unit Price AQ Zero Dead Union, SS, with 0-3 fittings ea Note: Additional union (AQ0-8507) may be necessary for SecurityGuard to fit in column oven with less than 30 cm length capacity. Phenogel columns are routinely shipped in THF. However, columns are also available in commonly used solvents, Chloroform and DMF, for an additional charge. Please specify shipping solvent when ordering.

22 ORDERING INFORMATION UHPLC/HPLC: Core-Shell Kinetex 5 μm Analytical Columns (mm) SecurityGuard ULTRA Cartridges Phases 50 x x x x 4.6 3/pk EVO C8 00B-4633-E0 00D-4633-E0 00F-4633-E0 00G-4633-E0 AJ0-996 Biphenyl 00B-467-E0 00D-467-E0 00F-467-E0 00G-467-E0 AJ0-907 XB-C8 00B-4605-E0 00D-4605-E0 00F-4605-E0 00G-4605-E0 AJ C8 00B-460-E0 00D-460-E0 00F-460-E0 00G-460-E0 AJ C8 00B-4608-E0 00D-4608-E0 00F-4608-E0 00G-4608-E0 AJ Phenyl-Hexyl 00B-4603-E0 00D-4603-E0 00F-4603-E0 00G-4603-E0 AJ μm Analytical Columns (mm) SecurityGuard ULTRA Cartridges Phases 00 x x 4.6 3/pk for 4.6 mm ID Core-Shell Technology Protect your UHPLC/HPLC columns from contaminants and extend their lifetime. guardit XB-C8 00D-4744-E0 00F-4744-E0 AJ for 4.6 mm ID.6 μm Analytical Columns (mm) SecurityGuard ULTRA Cartridges Phases 30 x x x x x 4.6 3/pk EVO C8 00B-475-E0 00D-475-E0 00F-475-E0 AJ0-996 F5 00B-473-E0 00D-473-E0 00F-473-E0 AJ0-930 Biphenyl 00B-46-E0 00D-46-E0 00F-46-E0 AJ0-907 XB-C8 00B-4496-E0 00C-4496-E0 00D-4496-E0 00F-4496-E0 AJ C8 00A-446-E0 00B-446-E0 00C-446-E0 00D-446-E0 00F-446-E0 AJ C8 00B-4497-E0 00C-4497-E0 00D-4497-E0 00F-4497-E0 AJ HILIC 00B-446-E0 00C-446-E0 00D-446-E0 00F-446-E0 AJ0-877 Phenyl-Hexyl 00B-4495-E0 00C-4495-E0 00D-4495-E0 00F-4495-E0 AJ μm Minibore Columns (mm) SecurityGuard ULTRA Cartridges Phases 30 x. 50 x. 00 x. 50 x. 3/pk EVO C8 00B-476-AN 00D-476-AN 00F-476-AN AJ0-998 for 4.6 mm ID F5 00B-47-AN 00D-47-AN 00F-47-AN AJ0-93 Biphenyl 00A-468-AN 00B-468-AN 00D-468-AN 00F-468-AN AJ0-909 XB-C8 00A-4498-AN 00B-4498-AN 00D-4498-AN 00F-4498-AN AJ0-878 C8 00A-4475-AN 00B-4475-AN 00D-4475-AN 00F-4475-AN AJ0-878 C8 00A-4499-AN 00B-4499-AN 00D-4499-AN 00F-4499-AN AJ HILIC 00A-4474-AN 00B-4474-AN 00D-4474-AN AJ Phenyl-Hexyl 00B-4500-AN 00D-4500-AN 00F-4500-AN AJ for. mm ID SecurityGuard ULTRA Cartridges require holder, Part No.: AJ μm Minibore Columns (mm) Phases 30 x. 50 x. C8 00A-455-AN 00B-455-AN To view the latest updates, please visit: Phenomenex l WEB:

23 UHPLC/HPLC: Fully Porous Luna Omega.6 μm Minibore Columns (mm) SecurityGuard ULTRA Cartridges 50 x. 00 x. 50 x. 3/pk C8 00B-474-AN 00D-474-AN 00F-474-AN AJ0-950 Polar C8 00B-4748-AN 00D-4748-AN 00F-4748-AN AJ for. mm ID SecurityGuard ULTRA Cartridges require holder, Part No.: AJ μm High Speed Technology (HST) Columns (mm) 50 x.0 30 x.0 50 x.0 00 x.0 50 x x 3.0 C8 00B-4446-A0 00A-4446-B0 00B-4446-B0 00D-4446-B0 00B-4446-Y0 00D-4446-Y0 Convenient and inexpensive way to remove particulates from HPLC samples Phenex ORDERING INFORMATION 3 μm Analytical Columns (mm) SecurityGuard Cartridges (mm) Phases 30 x x x x x x 3.0 * /0pk Silica() 00A-46-E0 00B-46-E0 00C-46-E0 00D-46-E0 00F-46-E0 AJ C8() 00A-448-E0 00B-448-E0 00C-448-E0 00D-448-E0 00F-448-E0 AJ0-490 C8() 00A-45-E0 00B-45-E0 00C-45-E0 00D-45-E0 00F-45-E0 AJ0-487 CN 00A-454-E0 00B-454-E0 00C-454-E0 00D-454-E0 00F-454-E0 AJ Phenyl-Hexyl 00A-456-E0 00B-456-E0 00C-456-E0 00D-456-E0 00F-456-E0 AJ0-435 NH 00B-4377-E0 00D-4377-E0 00F-4377-E0 AJ0-430 HILIC 00D-4449-E0 00F-4449-E0 AJ0-839 PFP() 00B-4447-E0 00D-4447-E0 00F-4447-E0 AJ0-837 for ID: mm 5 μm Analytical Columns (mm) SecurityGuard Cartridges (mm) Phases 30 x x x x x x x 3.0 * Silica() 00B-474-E0 00D-474-E0 00F-474-E0 00G-474-E0 AJ C5 00B-4043-E0 00D-4043-E0 00F-4043-E0 00G-4043-E0 AJ0-493 C8() 00A-449-E0 00B-449-E0 00C-449-E0 00D-449-E0 00F-449-E0 00G-449-E0 AJ0-490 C8() 00A-45-E0 00B-45-E0 00C-45-E0 00D-45-E0 00F-45-E0 00G-45-E0 AJ0-487 CN 00A-455-E0 00B-455-E0 00C-455-E0 00D-455-E0 00F-455-E0 00G-455-E0 AJ Phenyl-Hexyl 00A-457-E0 00B-457-E0 00D-457-E0 00F-457-E0 00G-457-E0 AJ0-435 NH 00A-4378-E0 00B-4378-E0 00D-4378-E0 00F-4378-E0 00G-4378-E0 AJ0-430 SCX 00B-4398-E0 00D-4398-E0 00F-4398-E0 00G-4398-E0 AJ HILIC 00D-4450-E0 00F-4450-E0 00G-4450-E0 AJ0-839 PFP() 00B-4448-E0 00D-4448-E0 00F-4448-E0 00G-4448-E0 AJ0-837 SecurityGuard Analytical Cartridges require universal holder, Part No.: KJ0-48 /0pk mm If Phenomenex products in this brochure do not provide at least an equivalent separation as compared to other products of the same phase and dimensions, return the product with comparative data within 45 days for a FULL REFUND To view the latest updates, please visit: 3

24 VOL. PHARMACEUTICAL ANALYSIS GUIDE IMPROVE YOUR FORMULATIONS ASSAYS TODAY PHARMACEUTICAL SCIENCES ANALYTICAL DEVELOPMENT Australia t: +6 (0) f: +6 (0) Luxembourg t: +3 (0) f: +3 (0) Austria t: +43 (0) f: +43 (0) Belgium t: +3 (0) (French) t: +3 (0) (Dutch) f: +3 (0) beinfo@phenomenex.com Canada t: + (800) f: + (30) info@phenomenex.com China t: +86 (0) f: +86 (0) chinainfo@phenomenex.com Denmark t: f: nordicinfo@phenomenex.com Finland t: +358 (0) f: nordicinfo@phenomenex.com France t: +33 (0) f: +33 (0) franceinfo@phenomenex.com Germany t: +49 (0) f: +49 (0) anfrage@phenomenex.com India t: +9 (0) f: +9 (0) indiainfo@phenomenex.com Ireland t: +353 (0) f: eireinfo@phenomenex.com Mexico t: f: tecnicomx@phenomenex.com The Netherlands t: +3 (0) f: +3 (0) nlinfo@phenomenex.com New Zealand t: +64 (0) f: +64 (0) nzinfo@phenomenex.com Norway t: f: nordicinfo@phenomenex.com Puerto Rico t: + (800) 54-HPLC f: + (30) info@phenomenex.com Spain t: f: espinfo@phenomenex.com Sweden t: +46 (0) f: nordicinfo@phenomenex.com United Kingdom t: +44 (0) f: +44 (0) ukinfo@phenomenex.com USA t: + (30) f: + (30) info@phenomenex.com All other countries Corporate Office USA t: + (30) f: + (30) info@phenomenex.com Italy t: f: italiainfo@phenomenex.com Phenomenex products are available worldwide. For the distributor in your country, contact Phenomenex USA, International Department at international@phenomenex.com BR403036_W Terms and Conditions Offer on front cover of this brochure is valid only for addressee and cannot be combined with any other discount or promotional item. Subject to Phenomenex Standard Terms & Conditions, which may be viewed at Trademarks Phenomenex, Luna, Kinetex, Yarra, Gemini, Aeris, and Jupiter, are registered trademarks of Phenomenex. Zebron, Onyx, Synergi, BioSep, Prodigy, PolymerX, PolySep, Phenogel, Rezex, ZB-WAXPLUS, 5MSPLUS, Inferno, and SecurityGuard are trademarks of Phenomenex. Aminex is a trademark of Bio-Rad Laboratories, Inc. TWEEN is a registered trademark of Croda International PLC. Advil is registered trademark of Wyeth Consumer Healthcare. LIQUI-GELS is a registered trademark of Catalent Pharma Solutions, Inc. Disclaimer Phenomenex is not affiliated with Advanced Materials Technology, Agilent Technologies, BioRad, or Waters Corporation. Comparative separations may not be representative of all applications. Kinetex EVO is patented by Phenomenex. U.S. Patent No. 7,563,367 and 8,658,038 and foreign counterparts. SecurityGuard is patented by Phenomenex U.S. Patent No. 6, 6, 36. CAUTION: this patent only applies to the analytical-sized guard cartridgs holder, and dose not apply to SemiPrep, PREP or ULTRA holders, or to any cartridges. 06 Phenomenex, Inc. All rights reserved.