QUALITY Quality Excipients for Pharma and Biopharma Applications

Size: px
Start display at page:

Download "QUALITY Quality Excipients for Pharma and Biopharma Applications"

Transcription

1 QUALITY Quality Excipients for Pharma and Biopharma Applications

2 Excipients for Pharmaceutical Production This is a selection of top products, if you are interested in a specific product that is not listed, please contact us. Buffering agents Control of ph is critical to avoid degradation of drug during processing, storage and reconstitution, there by necessitating addition of buffering agents in the Injectable formulation. Wide range of buffering agents are available in order to achieve predetermined ph range for the maximum stability and solubility of the API. CI132 SO138 SO187 S1986 AM180 Citric Acid Monohydrate, Granular, USP Dibasic Sodium Phosphate, Dried, USP Monobasic Sodium Phosphate, Anhydrous, USP Sodium Citrate, Anhydrous, USP Strong Ammonia Solution, NF About us At PLANET SCIENCE, we understand our customers need and provide them, with the best suitable solution. Our customers demand the best, That s where PLANET SCIENCE is invaluable. When you need the best - we deliver. We not only provide the highest quality products but also technical support and regulatory documentation support for all our ingredients. Our in-house expertise on the end use application of our products is complemented by the technical excellence of the scientists at Spectrum Chemicals USA, Panreac Applichem Germany and Koster Keunen USA. Because of our long cherished relationship with these wizards, our customers automatically get access to the decades of scientific and technical experience from all our principals Spectrum, Panreac & Koster. PLANET SCIENCE & its principals do not cut corners, we stand behind our products to assure you, our valued customer, the highest quality excipients. We bring all our USP, EP, BP, JP, FCC grade excipients from current Good Manufacturing Practices (cgmp) per 21CFR, part 210 and 211 of the code of federal regulations, our FDA registered and inspected manufacturing, packaging and storing facilities, will support and make sure you need not receive anything less than the highest grade of excipients at the best price. Their state-of-the art manufacturing facilities are always dedicated to providing products that exceed industry standards. In order to provide timely service to our customers, we maintain inventory for our fast moving products at our central warehouse situated at Mumbai. Call PLANET SCIENCE today, and put our experience, expertise, and resources to work for you. Solvents & Co-Solvents Co- Solvents & Solvents are used in the formulation for increasing drug solubility and primary drying rate in case of lyophilized products and in certain case enhance the sterility assurance of sample solution. BE159 Benzyl Benzoate, USP Benzyl Benzoate (USP, BP, Ph. Eur.) Pharma Grade Benzyl Alcohol (USP-NF, BP, Ph. Eur.) Pharma Grade DU0462 Dibutyl Phthalate, NF (Complies BP) Dichloromethane stabilized with ~ 20 ppm of amylene (USP-NF, BP, Ph. Eur.) Pharma Grade Dimethyl Sulfoxide (USP, BP, Ph. Eur.) Pharma Grade N,N-Dimethylacetamide (BP, Ph. Eur.), Pharma Grade ET108 Ethanol 95% (190 Proof), USP Ethanol 96% v/v (Ph.Eur, BP, USP) GMP- IPEC Grade Ethanol absolute (Ph. Eur, BP, USP-NF, JP) GMP-IPEC Grade Hexylene Glycol (USP-NF), Pharma Grade Oleic Acid (Ph. Eur.) Pharma Grade O1181C Oleic Acid, NF Propanol (USP, BP, Ph. Eur.), Pharma Grade BR0294 Tert-Butyl Alcohol, ACS (Complies reag. USP ) Triethanolamine (BP, Ph. Eur., USP-NF), Pharma Grade Complexing agents Complexing agents are used to increase aqueous solubility of poorly soluble drugs and to increase their bioavailability and stability. H1235C S2400C (2-Hydroxypropyl)-beta-cyclodextrin (HPBCD), EP Sulfobutylether beta cyclodextrin sodium (SBEBCD), USP

3 Antimicrobial preservatives Antimicrobial preservatives are used to kill or prevent growth of bacteria, yeast and mould in the dosage forms, antimicrobial agents are added to multi-dose formulations to prevent microbial growth during its shelf life and also added in the diluent for reconstitution of multidose container. BE158 Benzyl Alcohol, NF Benzyl Alcohol (USP-NF, BP, Ph. Eur.) Pharma Grade Chlorocresol, (USP-NF, BP, Ph. Eur.) Pharma Grade C2773 Metacresol, USP,EP ( Inj Grade ) Methylparaben (USP-NF, BP, Ph. Eur., JP) Pharma Grade ME163 Methylparaben, NF P1077 Phenoxyethanol, ( Complies NF) P1058 Phenylethyl Alcohol, USP PO301 Potassium Sorbate, Granular, NF PO300 Potassium Sorbate, Powder, NF PR133 Propylparaben, NF, BP, EP SO215 Sorbic Acid, Powder, NF Sorbic Acid (USP-NF, BP, Ph. Eur.) Pharma Grade S1172 Sodium Bisulfite, Granular, FCC ( Complies USP) Viscosity modifier/viscosity building agents Viscosity modifiers are used in pharmaceutical formulations to provide desired thickness to achieve suspendibility. We have wide range of CMC sodium with varied viscosity for optimum sedimentation rate. CA193 Carboxymethylcellulose Sodium, Low Viscosity, Viscosity of 2 Percent Aqueous 25 DEG C: cp, USP ph modifiers / ph adjusting agents A ph modifier is an acidifying or alkalizing agent used extensively in Injectable formulations to achieve a desirable ph for drug solubility, activity, absorption, stability and most importantly patient comfort. AL226 Dried Aluminum Hydroxide Gel, Powder, USP H1235C Hydroxypropyl beta-cyclodextrin (HPBCD) EP (Inj. Grade) L1010 Lactic Acid, Racemic, USP S2690C Sulfobutylether beta cyclodextrin sodium, USP (Inj. Grade) TA105 Tartaric Acid, Granular, NF L(+)-Tartaric Acid (USP-NF, BP, Ph. Eur.) pharma grade Tonicity adjusting agents Parenteral formulations should be isotonic with human plasma so as to avoid damage to the tissues. Utmost care should be taken, when either the injection volume or the infusion rate is higher, in case of intravenous injection. DE140 DE145 Dextrose, Anhydrous, Granular, USP, EP, BP, JP Dextrose, Monohydrate, Powder, USP Thickeners/Thicking agents A thickening agent or thickener is a substance which can increase the viscosity of a liquid without substantially changing its other properties. GU117 GU115 C1888 GM331C WAX#262P Emulsifiers & Stabilizers Emulsifiers are substances which make it possible to form or maintain a homogenous mixture of two or more immiscible phases such as oil and water in a foodstuff. Stabilizers are substances which make it possible to maintain the physico-chemical state of a product. Stabilizers include substances which enable the maintenance of a homogenous dispersion of two or more immiscible substances. GM331C IS160 M1122 M1122C PO125 Glyceryl Monostearate, USP Isopropyl Palmitate, NF Meglumine, USP Meglumine, USP,BP, EP, JP Polyethylene Glycol 3350, NF P1154 Polyethylene Glycol 400 Monostearate ( DMF Grade ) S1485 Sodium Tartrate, Dihydrate, Crystal, Reagent, ACS Sodium Tartrate, Dihydrate Reag. (Ph.Eur) Analysis Sorbitan Monolaurate (USP-NF, BP, Ph. Eur.) Pharma Grade SPA63 Acacia, Milled Powder, NF Acacia, Spray-Dried Powder, NF Cetostearyl Alcohol, NF Glyceryl Monostearate, USP White Beeswax, NF Sorbitan Monostearate, NF Sorbitan Monostearate (USP-NF, BP, Ph. Eur.) Pharma Grade Antioxidants & Reducing agents An antioxidant is a molecule that inhibits the oxidation of other molecules or itself gets oxidized in place of active. AS105 Ascorbic Acid, Crystalline Powder, USP AS102 Ascorbic Acid, Granular, USP L(+)-Ascorbic Acid (USP, BP, Ph. Eur.) Pharma Grade Butylated Hydroxytoluene (BP, Ph. Eur.) Pharma Grade B1196 Butylated Hydroxytoluene, Granular, NF Butylated Hydroxyanisole Powder (USP-NF, BP, Ph. Eur.) Pharma Grade B1194 Butylated Hydroxyanisole, Flakes, NF M1177 Monothioglycerol ( Complies USP ) P1453 Propyl Gallate, NF S1349 Sodium Ascorbate, Powder, USP S1172 Sodium Bisulfite, Granular, FCC ( Complies USP)

4 Oils for Pharma & Personal Care Molecules that are non-ionisable, lipophilic, and nonpolar are challenging to formulate due to their low water solubility and no effect of ph on solubility, thus non polar oils are mostly used to solve the purpose Castor Oil (BP, Ph. Eur.) Pharma Grade CA208 MI501 MI500 PE090 SO255 Castor Oil, USP Light Mineral Oil, NF Mineral Oil, USP Peanut Oil, NF Soybean Oil, USP Taste Modifiers/ Sweeteners Taste-modifying compounds or taste modifiers are chemical substances that alter one or more of the basic taste. Many studies have discovered numerous types of taste-modifying proteins found in nature that are categorized as having sweet, antisweet, and sweetness-inducing abilities. DE140 Dextrose, Anhydrous, Granular, USP, EP, BP, JP SO200 Saccharin Sodium, Dihydrate, Powder, USP SA105 Saccharin, Powder, NF L(+)-Tartaric Acid (USP-NF, BP, Ph. Eur.) Pharma Grade TA105 Tartaric Acid, Granular, NF Our Core Strengths Strict adherence to cgmp regulations Adopted IPEC-PQG GMP guide for pharmaceutical excipients Multinational principals from US & Europe, that are renowned and respected globally Comprehensive support for regulatory documentation Excipients for Injectable / Ophthalmic dosage forms Excipients for Dermatological/Semi-solid dosage forms Excipients for Liquid dosage forms Highly evolved business processes that meet the global quality standards Single product compliance to different pharmacopoeias (Multicompendial offerings) Sourcing from world renowned manufacturers across the globe Lubricants & Glidants Lubricants prevent ingredients from clumping together and from sticking to the tablet punches or capsule filling machine. Lubricants also ensure that tablet formation and ejection can occur with low friction between the solid and die wall. Glidants are used to promote powder flow by reducing interparticle friction and cohesion. These are used in combination with lubricants as they have no ability to reduce die wall friction. D1097 Diethyl Phthalate, NF Hexylene Glycol, USP Pharma Grade Custom-made products to meet specifications, precisely Prompt sample support for initiation of critical projects Highly skilled & technically sound manpower to resolve customer queries Wide variety of pack sizes that comply with both, R & D levels and commercial batches Zero compromise on customer-centric solutions Nationwide reach to support established and growing business entities Ample warehouse space to stock all fast moving products Ingredients/Constituents Benzoyl Peroxide humidified with ~ 25% of H 2 O (USP, BP, Ph. Eur.) Pharma Grade BE156 Hydrous Benzoyl Peroxide, USP C1473 Cysteine Hydrochloride, Monohydrate, USP G1044 Guar Gum, USP HY113 Hydroquinone, USP O1236 Octisalate, USP SA130 Salicylic Acid, Powder, USP Salicylic Acid (USP, BP, Ph. Eur.) Pharma Grade Sodium chloride ASTM B ( For Aeronautical Applications ) Sodium Succinate 6-hydrate for Pharma Analysis Logistic support that ensures JIT (Just in time) delivery High-priority for meeting safety standards, right from manufacturing to delivery Provision of audit (on request) at manufacturing plants

5 Registered Office: G,A-48, Lake City Mall, Kapurbavdi Circle, Thane (W) , Mumbai, Maharashtra, INDIA T: (100 Lines) For Technical Queries : E: info@planetscience.in W: A Division of Planet Science Sales Office: 706,Lodha Supremus,Road No 22, Wagle Industrial Estate, Thane(W) Mumbai, Maharashtra, INDIA T: (7 lines) E: info@qualityexcipients.com W:

Manufacturer of High Purity Chemicals PRODUCT LIST

Manufacturer of High Purity Chemicals PRODUCT LIST Manufacturer of High Purity Chemicals PRODUCT LIST Ammonium NH4 Ammonium Jost Chemical Co. manufactures a range of high purity ammonium phosphates, sulfates and citrates. Ammonium phosphates can be used

More information

PARENTERAL PREPARATIONS

PARENTERAL PREPARATIONS PARENTERAL PREPARATIONS INTRODUCTION Parenteral (Gk, para enteron, beside the intestine) dosage forms differ from all other drug dosage forms, because they are injected directly into body tissue through

More information

MANUFACTURER OF HIGH PURITY SPECIALTY CHEMICALS

MANUFACTURER OF HIGH PURITY SPECIALTY CHEMICALS The IPEC Excipient Stability Program Guide 2010 MANUFACTURER OF HIGH PURITY SPECIALTY CHEMICALS For the, nutraceutical, pharmaceutical, food & other specialty markets 1 Jost Chemical Founded by Jerry Jost

More information

ORAL DOSAGE OVERVIEW

ORAL DOSAGE OVERVIEW ORAL DOSAGE OVERVIEW AN UNWAVERING COMMITMENT TO ENABLING LIFE-SAVING PHARMACEUTICALS The safety of your patients is your number one priority. That s why the quality and stability of your formulations

More information

Preserving Pharmaceutical Products: Patrick Crowley

Preserving Pharmaceutical Products: Patrick Crowley Preserving Pharmaceutical Products: Patrick Crowley Pharmaceutical Products Modes of administration vary Oral Injection or infusion (parenteral) Inhalation (oral Intranasal Applied to skin ( topical )

More information

CAPMUL + CAPTEX + ACCONON = SEDDS

CAPMUL + CAPTEX + ACCONON = SEDDS OUR SOLUTIONS PORTFOLIO ABITEC products are specifically designed for meeting the solubility challenges of the pharmaceutical industry. Our products can be used alone or in conjunction with one another

More information

USP Perspective on Atypical Actives November 29, 2017

USP Perspective on Atypical Actives November 29, 2017 USP Perspective on Atypical Actives November 29, 2017 USP Excipients Stakeholder Forum USP Perspective on Atypical Actives Catherine Sheehan, M.S., M.S. Senior Director, Science Excipients Outline Role

More information

PHARMACEUTICAL AID PREPARED BY B.KIRUTHIGA LECTURER DEPT OF PHARMACEUTICAL CHEMISTRY

PHARMACEUTICAL AID PREPARED BY B.KIRUTHIGA LECTURER DEPT OF PHARMACEUTICAL CHEMISTRY PHARMACEUTICAL AID PREPARED BY B.KIRUTHIGA LECTURER DEPT OF PHARMACEUTICAL CHEMISTRY Excipients are inactive ingredients used as carriers for the active ingredients in a pharmaceutical product. These may

More information

LIQUID PREPARATIONS FOR ORAL USE. Final text for addition to The International Pharmacopoeia (November 2007)

LIQUID PREPARATIONS FOR ORAL USE. Final text for addition to The International Pharmacopoeia (November 2007) November 2007 LIQUID PREPARATIONS FOR ORAL USE Final text for addition to The International Pharmacopoeia (November 2007) This monograph was adopted at the Forty-second WHO Expert Committee on Specifications

More information

Q&A for submission of applications for prequalification of Zinc Sulfate tablets and Zinc Sulfate oral liquid (solution)

Q&A for submission of applications for prequalification of Zinc Sulfate tablets and Zinc Sulfate oral liquid (solution) Q&A for submission of applications for prequalification of Zinc Sulfate tablets and Zinc Sulfate oral liquid (solution) This document should not be treated as a comprehensive guideline; it serves as a

More information

CODEX STANDARD FOR BOUILLONS AND CONSOMMÉS (CODEX STAN , Rev )

CODEX STANDARD FOR BOUILLONS AND CONSOMMÉS (CODEX STAN , Rev ) CODEX STAN 117 Page 1 of 7 1 SCOPE CODEX STANDARD FOR BOUILLONS AND CONSOMMÉS (CODEX STAN 117-1981, Rev. 2-2001) This Standard applies to bouillons, consommés (meat and poultry) and similar products named

More information

Parenteral products-definition

Parenteral products-definition Parenteral products-definition Parenteral preparations are sterile, pyrogen-free liquids (solutions, emulsions, or suspensions) or solid dosage forms packaged in either single-dose or multidose containers.

More information

Mylan Laboratories Limited F-4 & F-12, Malegaon MIDC, Sinnar Nashik Maharashtra State, India

Mylan Laboratories Limited F-4 & F-12, Malegaon MIDC, Sinnar Nashik Maharashtra State, India This part reflects the scientific knowledge and the information about this product available at the time of prequalification. Thereafter, updates may have become necessary which are included in parts 1

More information

DRY SYRUPS SWAPNA.M. Ist semester DEPARTMENT OF PHARMACEUTICS UNIVERSITY COLLEGE OF PHARMACEUTICAL SCIENCES KAKATIYA UNIVERSITY, WARANGAL SEMINAR BY

DRY SYRUPS SWAPNA.M. Ist semester DEPARTMENT OF PHARMACEUTICS UNIVERSITY COLLEGE OF PHARMACEUTICAL SCIENCES KAKATIYA UNIVERSITY, WARANGAL SEMINAR BY DRY SYRUPS SEMINAR BY SWAPNA.M M.PHARMACY Ist semester DEPARTMENT OF PHARMACEUTICS UNIVERSITY COLLEGE OF PHARMACEUTICAL SCIENCES KAKATIYA UNIVERSITY, WARANGAL CONTENTS DEFINITION CHARACTERISTICS OF SUSPENSIONS

More information

Technical brochure StarLac

Technical brochure StarLac T R TABLETING AC DIRECT COMPRESSION CO-PROCESSED LACTOSE Technical brochure MEGGLE co-processed lactose grades for direct compression: General information Direct compression (DC) tablet manufacture is

More information

(RP) Handbook of Pharmaceutical Excipients. APhA. Raymond C Rowe. Paul J Sheskey. Sian C Owen FIFTH EDITION. Edited by

(RP) Handbook of Pharmaceutical Excipients. APhA. Raymond C Rowe. Paul J Sheskey. Sian C Owen FIFTH EDITION. Edited by Handbook of Pharmaceutical Excipients FIFTH EDITION Edited by Raymond C Rowe BPharm, PhD, DSc, FRPharmS, CChem, FRSC, CPhys, MlnstP Chief Scientist Intelligensys Ltd Billingham, UK Paul J Sheskey BSc,

More information

S. V. Enterprises.

S. V. Enterprises. +91-8048762993 S. V. Enterprises https://www.sventerpriseschem.com/ Being an ISO certified company, we are engaged in exporting and providing services of a wide assortment of Pharmaceutical Ingredients.

More information

CODEX STANDARD FOR DAIRY FAT SPREADS CODEX STAN

CODEX STANDARD FOR DAIRY FAT SPREADS CODEX STAN CODEX STAN 253-2006 1 CODEX STANDARD FOR DAIRY FAT SPREADS CODEX STAN 253-2006 1. SCOPE This Standard applies to dairy fat spreads intended for use as spreads for direct consumption, or for further processing,

More information

FROM SOLVENT TO AQUEOUS COATINGS. (Out of the Frying Pan...) Ralph E. Pondell. Coating Place, Inc. P.O. Box

FROM SOLVENT TO AQUEOUS COATINGS. (Out of the Frying Pan...) Ralph E. Pondell. Coating Place, Inc. P.O. Box 84-1 FROM SOLVENT TO AQUEOUS COATINGS (Out of the Frying Pan...) Ralph E. Pondell Coating Place, Inc. P.O. Box 930310 Verona, WI 53593 A number of reasons exist for the current high level of interest in

More information

OCE TABLETING DIRECT COMPRESSION CO-PROCESSED LACTOSE. Technical brochure MicroceLac 100

OCE TABLETING DIRECT COMPRESSION CO-PROCESSED LACTOSE. Technical brochure MicroceLac 100 IC OCE TABLETING DIRECT COMPRESSION CO-PROCESSED LACTOSE AC Technical brochure MEGGLE co-processed lactose grades for direct compression: General information Direct compression (DC) tablet manufacture

More information

PHARMACEUTICS I صيدالنيات 1 UNIT 1 INTRODUCTION

PHARMACEUTICS I صيدالنيات 1 UNIT 1 INTRODUCTION PHARMACEUTICS I صيدالنيات 1 UNIT 1 INTRODUCTION 1 PHARMACEUTICS Pharmaceutics is the science of dosage form design. The general area of study concerned with the formulation, manufacture, stability, and

More information

The Soft Gel Specialist

The Soft Gel Specialist Renown PHARMACEUTICALS PVT. LTD. The Soft Gel Specialist Prestigious History Welcome to Renown Pharmaceuticals Demand for Soft Gelatin Capsules is ever increasing for Nutraceuticals, Cosmetics and Herbals.

More information

Certification and Registrations:

Certification and Registrations: Macco production of mineral salts Since being established in 1976, Macco has experienced steady growth and today is a company that enjoys state of the art production facilities. We predominantly produce,

More information

REVISION OF MONOGRAPH ON TABLETS. Tablets

REVISION OF MONOGRAPH ON TABLETS. Tablets March 2011 REVISION OF MONOGRAPH ON TABLETS Final text for addition to The International Pharmacopoeia This monograph was adopted by the Forty-fourth WHO Expert Committee on Specifications for Pharmaceutical

More information

Biopharmaceutics Dosage form factors influencing bioavailability Lec:5

Biopharmaceutics Dosage form factors influencing bioavailability Lec:5 Biopharmaceutics Dosage form factors influencing bioavailability Lec:5 Ali Y Ali BSc Pharmacy MSc Industrial Pharmaceutical Sciences Dept. of Pharmaceutics School of Pharmacy University of Sulaimani 09/01/2019

More information

LubriTose Mannitol Michael Crowley, Director of R&D, Excipients

LubriTose Mannitol Michael Crowley, Director of R&D, Excipients LubriTose Mannitol Michael Crowley, Director of R&D, Excipients Introduction Michael Crowley Director of R&D Excipients 158 St. Highway 320 Norwich, NY 13815 PH 315-802-5970 Michael.Crowley@Kerry.com 2

More information

02/09/2016. Roles of Excipients in Pharmaceuticals:

02/09/2016. Roles of Excipients in Pharmaceuticals: Definition: Any substance other than the active drug or prodrug that is included in the manufacturing process or is contained in a finished pharmaceutical dosage form. Excipients are not inactive and have

More information

GMP GMP. What is it and why do we need it? Dennis Reiswig. The FDA. USP & NF History. Regulatory Definitions. (Good Manufacturing Practices)

GMP GMP. What is it and why do we need it? Dennis Reiswig. The FDA. USP & NF History. Regulatory Definitions. (Good Manufacturing Practices) 2007 Intertanko GMP Presentation GMP What is it and why do we need it? Dennis Reiswig Sr. Quality Specialist The Dow Chemical Company Regulatory Definitions GMP CFR FDA (Good Manufacturing Practices) (Code

More information

The unlocked synergy of DFE Pharma MCC

The unlocked synergy of DFE Pharma MCC The unlocked synergy of DFE Pharma MCC We are DFE Pharma We are the global leader in excipient solutions. We develop, produce and market excipients for oral solid dose and dry powder inhalation formulations.

More information

SCIENTIFIC DISCUSSION. Lopinavir and Ritonavir 200 mg/50 mg Tablets * Name of the Finished Pharmaceutical Product:

SCIENTIFIC DISCUSSION. Lopinavir and Ritonavir 200 mg/50 mg Tablets * Name of the Finished Pharmaceutical Product: SCIENTIFIC DISCUSSION Name of the Finished Pharmaceutical Product: Manufacturer of Prequalified Product: Active Pharmaceutical Ingredients (APIs): Pharmaco-therapeutic group (ATC Code): Therapeutic indication:

More information

» Monohydrate Citric Acid contains one molecule of water of hydration. It contains not less than 99.5 percent and not more than 100.

» Monohydrate Citric Acid contains one molecule of water of hydration. It contains not less than 99.5 percent and not more than 100. BRIEFING Citric Acid, Monohydrate. The European Pharmacopoeia is the coordinating pharmacopeia for the international harmonization of the compendial standards for the Citric Acid, Monohydrate monograph,

More information

Excipient Functionality & Pharmacopoeia IPEC Europe Excipients Forum Nice, 5 February 2015

Excipient Functionality & Pharmacopoeia IPEC Europe Excipients Forum Nice, 5 February 2015 Excipient Functionality & Pharmacopoeia IPEC Europe Excipients Forum Nice, 5 February 2015 Dr. Susanne Keitel Director EDQM, Council of Europe Outline 1. The European Pharmacopoeia 2. The importance of

More information

Paper No.: 13 Paper Title: Food Additives Module 2. Functional Classification of Food Additives

Paper No.: 13 Paper Title: Food Additives Module 2. Functional Classification of Food Additives Paper No.: 13 Paper Title: Food Additives Module 2. Functional Classification of Food Additives 2.1 Introduction According to the Food Protection Committee of the Food and Nutrition Board, food additives

More information

Easy, fast and reliable!

Easy, fast and reliable! Product Overview Easy, fast and reliable! Special easy-to-use preparations for film coating, sugar-coating, colouring and tabletting. Tailormade formulated. s film coating products are one-step coating

More information

innovative products. faster to market. reliably supplied.

innovative products. faster to market. reliably supplied. innovative products. faster to market. reliably supplied. consumer health E DEVELOPMENT DELIVERY SUPPLY We create unique, tailored consumer health solutions to help your brand grow. With more differentiated

More information

BRIEFING. Nonharmonized attributes: Identification, Heavy metals, Characters, Labeling, Bacterial endotoxins, Sterility, Storage.

BRIEFING. Nonharmonized attributes: Identification, Heavy metals, Characters, Labeling, Bacterial endotoxins, Sterility, Storage. BRIEFING Citric Acid, Anhydrous, page 872 of PF 28(3) [May June 2002]. The European Pharmacopoeia is the coordinating pharmacopeia for the international harmonization of the compendial standards for the

More information

EXPANDING WHAT S POSSIBLE WITH THE RIGHT PARTNER. Life-saving pharmaceuticals start with high-quality ingredients

EXPANDING WHAT S POSSIBLE WITH THE RIGHT PARTNER. Life-saving pharmaceuticals start with high-quality ingredients EXPANDING WHAT S POSSIBLE WITH THE RIGHT PARTNER Life-saving pharmaceuticals start with high-quality ingredients CONFIDENCE STRAIGHT FROM THE SOURCE From oral dosage excipients (Rx, Gx, nutraceuticals

More information

+91-8048764645 Nikunj Chemicals http://www.nikunjchem.net/ Valued as a reliable manufacturer and exporter, we are engaged in offering the best quality of Industrial Chemicals. Their accurate composition,

More information

Medibios Laboratories Private Limited, India Nutraceutical / OTC & Cosmetics product List Product Description

Medibios Laboratories Private Limited, India Nutraceutical / OTC & Cosmetics product List Product Description Sr. No. Medibios Laboratories Private Limited, India Product Description 1 Calcium with Vitamin D3 and Mineral Tablets Each film-coated tablet contains: Calcium Carbonate BP equivalent to Elemental Calcium

More information

Nutrition Facts. Cake and Danish Nutrition and Ingredient Information. Angel Food Cake

Nutrition Facts. Cake and Danish Nutrition and Ingredient Information. Angel Food Cake Cake and Danish Nutrition and Ingredient Information Nutrition Facts Serving size (g) Calories Calories from fat Total fat (g) Saturated Fat (g) Trans Fat (g) Chol (mg) Sodium (mg) Total Carb (g) Dietary

More information

Kolliwax HCO. Technical Information. Hydrogenated castor oil powder for pharmaceutical use. = Registered trademark in many countries.

Kolliwax HCO. Technical Information. Hydrogenated castor oil powder for pharmaceutical use. = Registered trademark in many countries. Technical Information Kolliwax HCO September 2015 03_150617e_00/Page 1 of 8 WF-No. 129938 = Registered trademark in many countries Hydrogenated castor oil powder for pharmaceutical use 03_150617e_00 September

More information

Why and how does a pharmaceutical company take the risk to use novel excipients?

Why and how does a pharmaceutical company take the risk to use novel excipients? Why and how does a pharmaceutical company take the risk to use novel excipients? M. Sherry Ku, Ph.D. CSO, Anchen Pharmaceuticals Irvine, CA Excipient Fest, May 5, 2010 Puerto Rico Global Excipient Acceptability

More information

VIVAPUR MCG. Microcrystalline Cellulose (MCC) and Carboxymethylcellulose Sodium (Na-CMC), NF, Ph.Eur., E460(i)&E466. Dispersible Cellulose

VIVAPUR MCG. Microcrystalline Cellulose (MCC) and Carboxymethylcellulose Sodium (Na-CMC), NF, Ph.Eur., E460(i)&E466. Dispersible Cellulose Microcrystalline Cellulose (MCC) and Carboxymethylcellulose Sodium (Na-CMC), NF, Ph.Eur., E460(i)&E466 Dispersible Cellulose High Performance Stabilizing Agent for Suspensions, Reconstitutable Powders,

More information

040716_ANDI_VENTIS WEBSITE(new) Printout 1. HOME PAGE. Welcome to our world of Dry Powder Inhalers!

040716_ANDI_VENTIS WEBSITE(new) Printout 1. HOME PAGE. Welcome to our world of Dry Powder Inhalers! 1. HOME PAGE Welcome to our world of Dry Powder Inhalers! Andi-Ventis Ltd, established in 2001 is a joint venture between Medochemie Ltd, Cyprus and Miat SpA Italy, founded to carry out the pharmaceutical

More information

STANDARD FOR CREAM AND PREPARED CREAMS

STANDARD FOR CREAM AND PREPARED CREAMS 1 Codex Standard 288-1976 STANDARD FOR CREAM AND PREPARED CREAMS CODEX STAN 288-1976 1. SCOPE This Standard applies to cream and prepared creams for direct consumption or further processing as defined

More information

EUDRAGIT L 100 and EUDRAGIT S 100

EUDRAGIT L 100 and EUDRAGIT S 100 Technical Information EUDRAGIT L 100 and EUDRAGIT S 100 Specification and Test Methods Ph. Eur. Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)

More information

Glydant Plus Liquid (patented) Broad Spectrum Product Protection

Glydant Plus Liquid (patented) Broad Spectrum Product Protection Personal Care Consumer Care Glydant Plus Liquid (patented) Broad Spectrum Product Protection INCI Name: DMDM Hydantoin & Iodopropynyl Butylcarbanate (IPBC) Key Product Attributes: Highly cost-effective

More information

Emulsions. Purpose of emulsions and of emulsification:

Emulsions. Purpose of emulsions and of emulsification: Pharmacist Ghada Hamid Emulsions Emulsion is a dispersion in which the dispersed phase is composed of small globules of a liquid distributed throughout a vehicle in which it is immiscible. The dispersed

More information

EXCIPIENTS FOR PHARMACEUTICALS

EXCIPIENTS FOR PHARMACEUTICALS EXCIPIENTS FOR PHARMACEUTICALS SCOPE OF APPLICATION IOI Oleo GmbH PHARMA Contents Regulatory background for the IOI Oleo site in Witten: Regulatory background for the IOI Oleo site in Witten... 3 Injectables

More information

גדות תעשיות ביוכימיה בע"מ Gadot Biochemical Industries Ltd.

גדות תעשיות ביוכימיה בעמ Gadot Biochemical Industries Ltd. Description: Tri Sodium Citrate Dihydrate is a white crystalline product. General Characteristics: Formula: C 6 H 5 Na 3 O. 7 2H 2 O Molecular weight: 294.11 Appearance: White crystals Taste: Saline taste

More information

General Concepts in the European Pharmacopoeia. Anne-Sophie Bouin European Pharmacopoeia Department, EDQM, Council of Europe

General Concepts in the European Pharmacopoeia. Anne-Sophie Bouin European Pharmacopoeia Department, EDQM, Council of Europe General Concepts in the European Pharmacopoeia Anne-Sophie Bouin European Pharmacopoeia Department, EDQM, Council of Europe General notices Anne-Sophie Bouin, 28/10/09 2009 EDQM, Council of Europe, All

More information

SCIENTIFIC DISCUSSION

SCIENTIFIC DISCUSSION SCIENTIFIC DISCUSSION Name of the Finished Pharmaceutical Product: Manufacturer of Prequalified Product: Active Pharmaceutical Ingredients (APIs): Pharmaco-therapeutic group (ATC Code): Therapeutic indication:

More information

Partner with the Global Leader in Drug Delivery Systems

Partner with the Global Leader in Drug Delivery Systems 3M DRUG DELIVERY SYSTEMS Partner with the Global Leader in Drug Delivery Systems Loughborough, United Kingdom Manufacturing Facility Experts at Commercializing Innovation 3M: Transforming New Ideas into

More information

Alvizia Healthcare Private Limited

Alvizia Healthcare Private Limited +91-8048413356 Alvizia Healthcare Private Limited https://www.alviziahealthcare.net/ We are one of the leading manufacturers, wholesaler and traders of the Pharmaceutical Products. Owing to their rich

More information

Easy, fast and reliable!

Easy, fast and reliable! Product Overview Easy, fast and reliable! Special easy-to-use preparations for film coating, sugar-coating, colouring and tabletting. s film coating products are one-step coating systems for pharmaceutical

More information

Citric Acid, Monohydrate

Citric Acid, Monohydrate Citric Acid, Monohydrate Product Regulatory Data Sheet Avantor Performance Materials, Inc. Section 1 Product Information Products Covered Brand Product Code Product Description J.T.Baker 0115 Citric Acid,

More information

Boehringer Ingelheim BioXcellence. Producing Value. Global Contract Manufacturing Excellence

Boehringer Ingelheim BioXcellence. Producing Value. Global Contract Manufacturing Excellence Boehringer Ingelheim BioXcellence Producing Value Global Contract Manufacturing Excellence Your World Class Contract Manufacturer Boehringer Ingelheim BioXcellence Producing Value Boehringer Ingelheim

More information

INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LIQUID PREPARATIONS FOR ORAL USE

INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LIQUID PREPARATIONS FOR ORAL USE RESTRICTED INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LIQUID PREPARATIONS FOR ORAL USE REVISED DRAFT FOR DISCUSSION World Health Organization 2007 All rights reserved. This draft is intended for a restricted

More information

[ 11 C]Mes-IMPY FOR INJECTION: CERTIFICATES OF ANALYSIS

[ 11 C]Mes-IMPY FOR INJECTION: CERTIFICATES OF ANALYSIS Table of Contents COA # Name Page Ware 1 COA of analytical column 3 2 COA of semi-prep column 4 3 COA of Millex GV 4 mm vent filter 5 4 COA of MiIlex MP 25 mm Sterile Filter 6 5 Sterile empty vial 7-9

More information

TABLET DESIGN AND FORMULATION

TABLET DESIGN AND FORMULATION TABLET DESIGN AND FORMULATION PART 5 Industrial pharmacy 5th class 1st semester TABLET DESIGN AND FORMULATION Conventional oral tablets for ingestion usually contain the same classes of components in addition

More information

FOOD INGREDIENTS NUMBERS WITH E- CODE. E-Number Name Description Status

FOOD INGREDIENTS NUMBERS WITH E- CODE. E-Number Name Description Status E100 Curcumin/Turmeric Color E101 Riboflavin (Vitamin B2) Color E102 Tartrazine Color E104 Quinoline Yellow Color powder or granular. Mushbooh if used as liquid, the solvents has to be. Haraam if hidden

More information

Review Article ISSN: Open Access. Regulatory Aspects of Pharmaceutical Excipients in India and their Qualification to Use in Pharmaceuticals

Review Article ISSN: Open Access. Regulatory Aspects of Pharmaceutical Excipients in India and their Qualification to Use in Pharmaceuticals Review Article ISSN: 2581-4559 Open Access UPI JOURNAL OF BUSINESS MANAGEMENT AND COMPUTER APPLICATIONS Journal Home Page: https://uniquepubinternational.com/upi-journals/upi-journal-ofbusiness-management-and-computer-applications-upi-jbmca/

More information

FLORITER. New Technology for Innovative Formulation Design.

FLORITER. New Technology for Innovative Formulation Design. FLORITER New Technology for Innovative Formulation Design www.tomitaph.co.jp FLORITE Dramatically Change Your Formulation FLORITE is synthetic Calcium Silicate with exceptional liquid absorbency and excellent

More information

DEVELOPMENT AND EVALUATION OF ORAL RECONSTITUTABLE SYSTEMS OF CEPHALEXIN

DEVELOPMENT AND EVALUATION OF ORAL RECONSTITUTABLE SYSTEMS OF CEPHALEXIN International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.2, No.1, pp 502-506, Jan-Mar 2010 DEVELOPMENT AND EVALUATION OF ORAL RECONSTITUTABLE SYSTEMS OF CEPHALEXIN Pradnya Palekar

More information

Leader in custom manufacturing. for the pharmaceutical and nutraceutical industries.

Leader in custom manufacturing. for the pharmaceutical and nutraceutical industries. Leader in custom manufacturing for the pharmaceutical and nutraceutical industries. Since its inception in April 1994, Viva Pharmaceutical Inc. has built a reputation as a leading manufacturer committed

More information

CODEX STANDARD FOR CREAM AND PREPARED CREAMS

CODEX STANDARD FOR CREAM AND PREPARED CREAMS CODEX STANDARD FOR CREAM AND PREPARED CREAMS CODEX STAN 288-1976 1. SCOPE This Standard applies to cream and prepared creams for direct consumption or further processing as defined in Section 2 of this

More information

SCIENTIFIC DISCUSSION. Antimycobacterial (J04AC01).

SCIENTIFIC DISCUSSION. Antimycobacterial (J04AC01). SCIENTIFIC DISCUSSION Name of the Finished Pharmaceutical Product: Manufacturer of Prequalified Product: Active Pharmaceutical Ingredients (APIs): International Nonproprietary Name: Pharmaco-therapeutic

More information

T1-1 Table 1. Target compounds and individual food additives.

T1-1 Table 1. Target compounds and individual food additives. T1-1 Table 1. Target compounds and individual food additives. No. 1 Aspartame Sweetener Aspartame D 1 1 2 Xylitol Sweetener Xylitol D 2 2 3 Glycyrrhizine Sweetener Disodium glycyrrhizinate D 3 3 Licorice

More information

S p e c i a l S a l t s Functional Minerals

S p e c i a l S a l t s Functional Minerals S p e c i a l S a l t s Functional Minerals Special Salts A unique range of high-purity organic mineral sources Jungbunzlauer is the global market leader for Special Salts which are functional minerals

More information

Food supplement manufacture

Food supplement manufacture Food supplement manufacture Nick Bennett BSc. RNutr April 2018 1 Introduction There are many different product formats available Liquids, powders, tablets, capsules etc Many different types of machine

More information

SCIENTIFIC DISCUSSION

SCIENTIFIC DISCUSSION This part reflects the scientific knowledge and the information about this product available at the time of prequalification. Thereafter, updates may have become necessary which are included in parts 1

More information

Pharma Ingredients & Services. Kolliphor HS 15. Macrogol 15 Hydroxystearate Ph. Eur. Polyoxyl 15 Hydroxystearate USP. Technical Information

Pharma Ingredients & Services. Kolliphor HS 15. Macrogol 15 Hydroxystearate Ph. Eur. Polyoxyl 15 Hydroxystearate USP. Technical Information Technical Information March 2012 Supersedes issue dated December 2011 03_111149e-02/Page 1 of 8 WF-No. 118491 Kolliphor HS 15 Macrogol 15 Hydroxystearate Ph. Eur. Polyoxyl 15 Hydroxystearate USP = Trademark

More information

The Chemistry and Use of 1,2-Alkanediols and Anti-oxidants for Product Protection

The Chemistry and Use of 1,2-Alkanediols and Anti-oxidants for Product Protection The Chemistry and Use of 1,2-Alkanediols and Anti-oxidants for Product Protection Ravi Pillai PAGE 1 1,2-ALKANEDIOLS CHEMISTRY Straight chain with two vicinal hydroxy groups CH 2 - CH - (CH 2 ) n - CH

More information

COLLEGE OF PHARMACY STERILE PRODUCTS PHT 434. Dr. Mohammad Javed Ansari Ph.D Contact info:

COLLEGE OF PHARMACY STERILE PRODUCTS PHT 434. Dr. Mohammad Javed Ansari Ph.D Contact info: COLLEGE OF PHARMACY STERILE PRODUCTS PHT 434 Dr. Mohammad Javed Ansari Ph.D Contact info: javedpharma@gmail.com OBJECTIVES OF THE LECTURE At the end of this lecture, you will be aware of: What are factors

More information

PRODUCT LIST. Human Nutrition

PRODUCT LIST. Human Nutrition PRODUCT LIST Human BAKERY AND COOKIES Powder rasing mixes. Stabilizer mixes and other bread improvers. Liquid and solid preservative blends. Humectants Anticaking agents Glycerine (E 422) Dioxide silicon

More information

SPS Pharma: Who we are?

SPS Pharma: Who we are? Applications in area of drug release using the flow through cell Society of Pharmaceutical Dissolution Science 26-27th July 2016 Ahmedabad (India) Samir Haddouchi samir.haddouchi@sps-pharma.com www.sps-pharma.com

More information

FORMULATION AND DEVELOPMENT OF ER METOPROLAOL SUCCINATE TABLETS

FORMULATION AND DEVELOPMENT OF ER METOPROLAOL SUCCINATE TABLETS International Journal of PharmTech Research CODEN( USA): IJPRIF ISSN : 0974-4304 Vol.1, No.3, pp 634-638, July-Sept 2009 FORMULATION AND DEVELOPMENT OF ER METOPROLAOL SUCCINATE TABLETS K. Reeta Vijaya

More information

Dow Wolff Cellulosics. Using ingenuity and savvy. TM Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow

Dow Wolff Cellulosics. Using ingenuity and savvy. TM Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow Dow Wolff Cellulosics Pharmaceutical Excipients Using ingenuity and savvy to help design healthcare solutions TM Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow Enhancing

More information

AAPS Annual Meeting, San Diego, CA November 12, 2017 Short Course. Pharmaceutical Excipients: Biopharmaceutical, QC and Regulatory Considerations

AAPS Annual Meeting, San Diego, CA November 12, 2017 Short Course. Pharmaceutical Excipients: Biopharmaceutical, QC and Regulatory Considerations AAPS Annual Meeting, San Diego, CA November 12, 2017 Short Course Pharmaceutical Excipients: Biopharmaceutical, QC and Regulatory Considerations Updating USP-NF Excipient Monographs: Challenges and Opportunities

More information

TENOFOVIR TABLETS: Final text for addition to The International Pharmacopoeia (June 2010)

TENOFOVIR TABLETS: Final text for addition to The International Pharmacopoeia (June 2010) June 2010 TENOFOVIR TABLETS: Final text for addition to The International Pharmacopoeia (June 2010) This monograph was adopted at the Forty-fourth WHO Expert Committee on Specifications for Pharmaceutical

More information

Ph. D Synopsis. Mr. Mehul Pravinchandra Patel Page 1

Ph. D Synopsis. Mr. Mehul Pravinchandra Patel Page 1 1. INTRODUCTION 1.1. Sustained Drug delivey: 1-6 It is defined as any drug or dosage form modification that prolongs the therapeutic activity of the drug. The amount of drug in the body decrease slowly

More information

Steven Schnittger Executive Director, Microbiology The Estēe Lauder Companies, Inc

Steven Schnittger Executive Director, Microbiology The Estēe Lauder Companies, Inc How to Preserve a Product in an Ever Changing Marketplace: The Shift from Conventional to Natural! Steven Schnittger Executive Director, Microbiology The Estēe Lauder Companies, Inc Overview The number

More information

SCIENTIFIC DISCUSSION

SCIENTIFIC DISCUSSION SCIENTIFIC DISCUSSION Name of the Finished Pharmaceutical Product: Manufacturer of Prequalified Product: Active Pharmaceutical Ingredients (APIs): Rifampicin/Isoniazid 150mg/75mg filmcoated Tablets Svizera

More information

هيئة التقييس لدول مجلس التعاون لدول الخليج العربية

هيئة التقييس لدول مجلس التعاون لدول الخليج العربية هيئة التقييس لدول مجلس التعاون لدول الخليج العربية G.C.C STANDARDIZATION ORGANIZATION (GSO) Final Draft GSO/FDS /2012 Frozen Prawn Coated with Bread Crump Prepared by: Gulf technical committee for sector

More information

Public Assessment Report Scientific discussion. Ciprofloxacin Accord (ciprofloxacin hydrochloride) SE/H/1026/01-03/DC

Public Assessment Report Scientific discussion. Ciprofloxacin Accord (ciprofloxacin hydrochloride) SE/H/1026/01-03/DC Public Assessment Report Scientific discussion Ciprofloxacin Accord (ciprofloxacin hydrochloride) SE/H/1026/01-03/DC This module reflects the scientific discussion for the approval of Ciprofloxacin Accord.

More information

REGIONAL STANDARD FOR CHILLI SAUCE CODEX STAN 306R-2011

REGIONAL STANDARD FOR CHILLI SAUCE CODEX STAN 306R-2011 REGIONAL STANDARD FOR CHILLI SAUCE CODEX STAN 306R-2011 Adopted in 2011. Amended in 2013, 2017. CODEX STAN 306R-2011 2 1. SCOPE This standard applies to chili sauce, as defined in Section 2 below, and

More information

CONCEPT ALLIED. Allied became reality when Industrial Experts thought of coming together to fructify business ideas!!!

CONCEPT ALLIED. Allied became reality when Industrial Experts thought of coming together to fructify business ideas!!! Redefining Quality CONCEPT ALLIED Allied became reality when Industrial Experts thought of coming together to fructify business ideas!!! Vision- To provide best quality soy & sunflower products globally

More information

My Perfect Pet Clean Label List

My Perfect Pet Clean Label List My Perfect Pet Clean Label List My Perfect Pet has always provided clean labels to our customers because transparency, sustainability, pet health, and the protection of our environment have always been

More information

SENSE THE DIFFERENCE. Product Overview Brenntag Food & Nutrition UK & Ireland.

SENSE THE DIFFERENCE. Product Overview Brenntag Food & Nutrition UK & Ireland. SENSE THE DIFFERENCE Product Overview UK & Ireland www.brenntag.com/food-nutrition 2 SENSE THE DIFFERENCE BRENNTAG FOOD & NUTRITION WE UNDERSTAND THE IMPORTANCE OF STRIKING THE RIGHT BALANCE, FROM A PRODUCT

More information

Product Information Sheet SODA-LO EXTRA FINE IODIZED

Product Information Sheet SODA-LO EXTRA FINE IODIZED Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide

More information

A Modern Approach to Excipient Quality Assurance

A Modern Approach to Excipient Quality Assurance A Modern Approach to Excipient Quality Assurance Steven Wolfgang, Ph.D. (Acting) Associate Director for Risk Science, Intelligence and Prioritization FDA/CDER/Office of Compliance/ Office of Drug Security,

More information

ERT 430 PHARMACEUTICAL PROCESS ENGINEERING PARENTERAL FORMULATION

ERT 430 PHARMACEUTICAL PROCESS ENGINEERING PARENTERAL FORMULATION ERT 430 PHARMACEUTICAL PROCESS ENGINEERING PARENTERAL FORMULATION OUTLINE Introduction Parenteral Product Requirement Parenteral Product Formulation: Solution Emulsion Suspension Evaluation of Parenteral

More information

A matter of timing. ensure optimal delivery for acid-sensitive products. capsugel.com

A matter of timing. ensure optimal delivery for acid-sensitive products. capsugel.com A matter of timing ensure optimal delivery for acid-sensitive products capsugel.com The preferred choice for you and your customers Capsugel DRcaps capsules offer nutritional supplement makers a dosage

More information

IPEC Europe Suggested Alternative (if none then original text is clear and needs no alteration) Purpose and Scope

IPEC Europe Suggested Alternative (if none then original text is clear and needs no alteration) Purpose and Scope IPEC Europe Observations and Recommendations on Guidelines On The Formalised Risk Assessment For Ascertaining The Appropriate Good Manufacturing Practice For Excipients Of Medicinal Products For Human

More information

This revision also necessitates a change in the table numbering in the test for Organic Impurities.

This revision also necessitates a change in the table numbering in the test for Organic Impurities. Methylphenidate Hydrochloride Extended-Release Tablets Type of Posting Notice of Intent to Revise Posting Date 27 Jul 2018 Targeted Official Date To Be Determined, Revision Bulletin Expert Committee Chemical

More information

Excipients. USP and NF Excipients, Listed by Category. Accessed from by newp0rt1 on Thu Dec 01 21:23:02 EST NF 30 Excipients 1673

Excipients. USP and NF Excipients, Listed by Category. Accessed from by newp0rt1 on Thu Dec 01 21:23:02 EST NF 30 Excipients 1673 NF 30 Excipients 1673 Excipients USP and NF Excipients, Listed by Category In the following reference table, the grouping of excipients by functional category is intended to summarize the most typically

More information

A New USP Tool The Class Monograph

A New USP Tool The Class Monograph CHPA Regulatory, Scientific & Quality Conference Washington DC, May 13, 2014 Quality Session 4 A New USP Tool The Class Monograph Alan R. Potts, Ph.D. Principal Scientific Liaison-Chemical Medicines The

More information

>>> Oral Formulation Optimization. Introduction. A Tiered Approach for Identifying Enabling Formulations

>>> Oral Formulation Optimization. Introduction. A Tiered Approach for Identifying Enabling Formulations Application Note #28-DMPK-3 >>> Oral Formulation Optimization Introduction Among the criteria required of compounds advancing from drug discovery programs, adequate systemic exposure (plasma concentrations

More information

NUTRILO YOUR COMPETENT PARTNER IN DIETARY SUPPLEMENTS

NUTRILO YOUR COMPETENT PARTNER IN DIETARY SUPPLEMENTS NUTRILO YOUR COMPETENT PARTNER IN DIETARY SUPPLEMENTS Growing expertise in healthy dietary supplements At the mouth of the River Elbe, at the edge of the Lower Saxony Wadden Sea National Park, Nutrilo

More information

DEKAs in Cystic Fibrosis

DEKAs in Cystic Fibrosis DEKAs in Cystic Fibrosis All-in-one Multivitamin & Mineral Dietary Supplement with Enhanced Absorption Roberto Jongejan, MD, PhD Gus Papas, MD, MPH Vitamin Malabsorption in Cystic Fibrosis In cystic fibrosis,

More information