Pure Health. Dow Propylene Glycol USP/EP for the Pharmaceutical Industry

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1 Animal Feed Cosmetics Pharmaceuticals Foods Pure Health Dow Propylene Glycol USP/EP for the Pharmaceutical Industry

2 Purity is essential in pharmaceutical applications. Dow Propylene Glycol USP/EP 1 offers one of the highest purity propylene glycols available in the marketplace with a specified purity of 99.8 percent or greater, non-detectable MEG/DEG 2 contents, adherence to IPEC-PQG 3 Good Manufacturing Practices for pharmaceutical excipients, and a two-year shelf life when stored according to Dow s recommendations. 4 Think of it as your security for purity. Dow PG USP/EP offers excellent versatility and functionality in pharmaceutical applications 5 : Solvent and extractant for a wide range of active ingredients, such as corticosteroids, phenol derivatives, barbiturates, vitamins A and D, most alkaloids and many local anesthetics 6 Emollient for softening and smoothing Humectant for promoting moisture retention in skin-care products Coupling agent Plasticizer in aqueous film coating formulations Emulsion stabilizer Dispersant Viscosity modifier In addition to consistent purity and excellent quality, Dow PG USP/EP is backed by comprehensive technical support and customer service, as well as global manufacturing and supply chain capabilities. 1 Dow PG USP/EP is tested against and complies with the specific requirements of current USP, EP and JP. It also meets, but is not tested against, Brazilian Pharmacopeia requirements. Dow s stringent PG USP/EP global manufacturing standards offer the availability of the same consistently pure, high-quality PG USP/EP product around the world. 2 Monoethylene Glycol/Diethylene Glycol. 3 International Pharmaceutical Excipients Council/Pharmaceutical Quality Group. 4 When stored below 104 ºF (40 ºC) in closed containers, protected from UV light. 5 An overview of typical uses of propylene glycol in pharmaceutical formulations is published in the Handbook of Pharmaceutical Excipients, fourth edition, edited by Raymond C. Rowe, Paul J. Sheskey and Paul J. Weller, Pharmaceutical Press and American Pharmaceutical Association, Inactive Ingredient Guide, U.S. Food and Drug Administration, 2008 lists various different dosage forms, routes of administration and maximum potency (concentration) of propylene glycol in approved drug products. (

3 Excellent Quality for Pure Confidence Dow Propylene Glycol USP/EP offers high quality and consistency, according to the industry s most stringent qualitycontrol processes, including adherence to Good Manufacturing Practices (GMP) from The Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients. Dow s commitment to GMP throughout the supply chain enables Dow PG USP/EP to be handled according to stringent requirements for consistent purity. Dow PG USP/EP is tested against and certified according to the requirements for the following standards: Food Chemicals Codex (FCC) United States Pharmacopeia (USP) European Pharmacopeia (PhEur or EP) Japanese Pharmacopeia (JP) All requirements of these monographs are included on Dow s globally applied Sales Specification and Certificate of Analysis (CoA) for Dow PG USP/EP, including, as of February 1, 2010, specific testing for MEG/DEG contents, which are both non-detectable in this product. For compendia items that are in statistical control and show limited analytical variation, tests are carried out on a statistical, quarterly basis as noted on the CoA. Dow PG USP/EP meets the requirements and standards of the U.S. Food and Drug Administration (FDA) and is approved for use in many other jurisdictions around the world as a non-active ingredient in pharmaceuticals. It is Generally Recognized As Safe (GRAS), due to its extremely low toxicity and long history of safe use, and is included in the Inactive Ingredient Guide in a variety of different dosage forms and routes of administration. Dow PG USP/EP also complies with the requirements for Residual Solvents per the U.S. Pharmacopeia/National Formulary (USP/NF) General Chapter <467> and the International Committee on Harmonization (ICH) Guideline Q3C Impurities: Guideline for Residual Solvents. It is manufactured from hydrocarbon raw materials without the use of any solvents or additives. There are no Class 1, Class 2, Class 3 or any other solvents used or produced in making Dow PG USP/EP.

4 Robust Supply Chain for Global Reach With nearly 60 years of experience as a leading propylene glycol (PG) manufacturer and supplier, Dow has built a robust supply chain network that provides: Reliable Global Supply from strategically located manufacturing sites in the U.S., Brazil, Germany and Australia. The Largest Production Capacity in North America, including plants in two different states. One of the World s Largest PG Production facilities in Stade, Germany. Presence in South America as the only domestic supplier to produce PG in this growing region. Inventory Management Solutions from strategically located terminals around the world to help meet changing customer needs. Quality, Storage, Packaging and Transportation according to the world s most stringent standards and documentation requirements for PG, including marine transport capabilities.

5 Exceptional Solutions for Pure Innovation Dow Propylene Glycol USP/EP is backed by excellent service and innovation: Hydrogen Peroxide to Propylene Oxide (HPPO) Technology, developed in a joint venture partnership with BASF, is one example of how Dow creates technologies that advance quality, reliability and sustainability. This innovative, low energy, high-yield process produces propylene oxide in a more environmentally friendly manner by reducing wastewater by approximately percent and energy use by approximately 35 percent compared with conventional propylene oxide manufacturing technology. This technological advance was recognized with the Institution of Chemical Engineers Innovation and Excellence Award in Core Engineering in 2009 and the U.S. Presidential Green Chemistry Challenge Award in TS&D Support for technical and EH&S experience to support customer application needs. In addition, customers can contact Dow for assistance in proper handling, storage and use of Dow PG USP/EP, in keeping with Dow s commitment to Responsible Care. In-Region Customer Service Representatives (CSRs) who are dedicated to helping customers use Dow PG USP/EP effectively, and providing support according to the customer s region. Sales Professionals who are committed to serving customers and championing their needs throughout the sales process. Education and Training, Including an Online Answer Center, available to customers 24 hours a day, seven days a week at

6 Ingredient Solubility Material % Solubility Material % Solubility Drugs and Medicinals Antiseptics Acetanilide 2.09 Camphor 9.80 Acetarsone 0.52 Calcium Sulfocarbolate > 30.00* Acethophenitidine 2.10 Chlorothymol Alion 4.37 Hexylesorcinol > 80.00* Antipyrine > Menthol > Caffeine 0.77 Merthiolate > Chloral Hydrate > Metaphen < 0.27 Ethyl Carbamate > Salol Glycine < 0.45 Thymol > Hexamethylenetetramine Trichloro-tert-butanol > o-hydroxybenzyl Alcohol Zinc Sulfocarbolate > Paraldehyde x Pepsin < 0.08 Vitamins and Hormones Phenobarbital > Estradiol (mg per cc) 0.50 (Luminal Sodium) Ascorbic Acid 8.16 Resorcinol Calcium Pantothenate 2.04 Sodium Bismuth Thioglycolate 9.40 Nicotinic Acid 0.88 Sodium Iodobismuthite 6.00 Pyridoxine Hydrochloride 2.73 Sulfadiazine 0.30 Riboflavin < Sulfanilamide 7.25 Thiamine Hydrochloride 5.14 Sulfapyridine 0.50 Vitamin A (12% in oil) insol. Sulfathiazole 1.71 Terpin Hydrate Organic Substances Urea Acacia Gum < 0.16 Calcium Glycerosphosphate < 0.07 Local Anesthetics Cetyle Alcohol 0.23 Benzocaine Pectin insol. Benzyl Alcohol x Phenothiazine (Purified) < 1.15 Diothane 5.00 Sodium Citrate 0.23 Salicyl Alcohol (Saligenin) 4.00 Tannic Acid > Inorganic Substances Cupric Oxide Ferric Oxide insol. insol. *Viscosity of solutions prevented further additions of solid > = greater than insol. = not soluble x = miscible or soluble in all proportions < = less than

7 Purity Plus A very high dedication to consistent quality and purity governs the entire product supply process for Dow Propylene Glycol USP/EP. Purity Plus describes Dow s dedication to pure excellence in propylene glycol: Purity means producing and handling Dow PG USP/EP according to the industry s most stringent standards. Plus refers to the support and confidence our customers have in Dow with nearly 60 years of PG experience, global customer and technical support, excellent product stewardship, and environment, health and safety practices.

8 Want to Know More? You can learn more about Dow Propylene Glycol USP/EP and Dow s other propylene glycol products at Or contact a Dow representative to discuss your specific application needs. North America Toll free: DOW (4369) Toll call: Asia Pacifc Toll free: * Toll call: Latin America Toll call: Europe, India, Middle East and Africa Toll free: ** Toll call: Italy toll free national: South Africa toll free national: * International toll free from Pacific countries Korea, Japan, China, Taiwan, Hong Kong, Thailand, Malaysia, Singapore, Philippines, Australia, New Zealand. Toll free service may not function from certain cell phones, hotel phones and some office PBX equipment. ** International toll free from Austria, Belgium, Denmark, Finland (prefix 990), France, Germany, Hungary, Ireland, The Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. NOTICE: No freedom from any patent owned by Dow or others is to be inferred. Because use conditions and applicable laws may differ from one location to another and may change with time, Customer is responsible for determining whether products and the information in this document are appropriate for Customer s use and for ensuring that Customer s workplace and disposal practices are in compliance with applicable laws and other government enactments. The product shown in this literature may not be available for sale and/or available in all geographies where Dow is represented. The claims made may not have been approved for use in all countries or regions. Dow assumes no obligation or liability for the information in this document. References to Dow or the Company mean the Dow legal entity selling the products to Customer unless otherwise expressly noted. NO EXPRESS WARRANTIES ARE GIVEN EXCEPT FOR ANY APPLICABLE WRITTEN WARRANTIES SPECIFICALLY PROVIDED BY DOW. ALL IMPLIED WARRANTIES INCLUDING THOSE OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE EXPRESSLY EXCLUDED. NOTICE: Any photographs of end-use applications in this document represent potential end-use applications but do not necessarily represent current commercial applications, nor do they represent an endorsement by Dow of the actual products. Further, these photographs are for illustration purposes only and do not reflect either an endorsement or sponsorship of any other manufacturer for a specific potential end-use product or application, or for Dow, or for specific products manufactured by Dow. References to Dow or the Company mean The Dow Chemical Company and its consolidated subsidiaries unless otherwise expressly noted. Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow Printed in U.S.A. February 2011 Responsible Care is a registered service mark of the American Chemistry Council in the United States Form No X-0211BBI