The Dow Chemical Company announced today that the Plaquemine, Louisiana and Freeport, Texas North American manufacturing operations of its newly branded propylene glycol (PG) USP/EP product – DOW PuraGuard™ Propylene Glycol USP/EP – has passed key independent quality audits and earned third-party certification from the International Pharmaceutical Excipients Auditing, Inc. (IPEA) for adherence to Good Manufacturing Practices (GMP) based on the Joint International Pharmaceutical Excipients Council (IPEC) and Pharmaceutical Quality Group (PQG) GMP Guide for Pharmaceutical Excipients. DOW PuraGuard PG USP/EP, which provides among the highest purity PG USP/EP on the market today, is the only PG USP/EP to have received this third-party IPEA GMP certification. IPEA is the ANSI accredited Product Certification Body that implements and promotes global use of appropriate IPEC standards for pharmaceutical excipients. 

 

DOW PuraGuard PG USP/EP is a clear, colorless, water-soluble and hygroscopic liquid with low vapor pressure that has 99.8 percent or greater specified purity (assay), non-detectable MEG/DEG and a two-year shelf life when stored according to Dow’s recommendations.  In addition to pharmaceuticals, the purity and versatility of DOW PuraGuard PG USP/EP allow it to be used as an ingredient in a variety of other products subject to very stringent quality standards including foods, beverages, cosmetics, personal care products and animal feed.  The product is also backed by Purity Plus, Dow’s commitment to quality and regulatory compliance at all levels of our global manufacturing and supply chain. This “security for purity” helps provide confidence to pharmaceutical manufacturers that the excipient product will be acceptable in their formulations, and also may save a step for manufacturers so they do not have to perform individual quality audits of Dow’s PG production facilities.

 

“The IPEA certification demonstrates Dow’s quality excellence with DOW PuraGuard PG USP/EP throughout the manufacturing process, in keeping with the industry’s rigorous quality-control practices,” says Paul Simons, Dow PG global product director and strategic marketing.  “With excellent purity and the backing of our Purity Plus program, Dow’s commitment to optimal quality throughout the entire supply chain helps assure that the product will meet or exceed stringent ingredient and excipient requirements.”

 

“Both North American DOW PuraGuard PG USP/EP manufacturing facilities have passed the GMP audit and have received certification to excipient GMPs from IPEA,” says Irwin Silverstein, Ph.D., IPEA VP and COO.  “IPEA’s independent third-party evaluation process helps ensure that excipients and related components in finished pharmaceutical products meet only the highest appropriate IPEC GMP standards throughout their manufacturing process.”

 

With the largest global production capacity for propylene glycol, Dow is the only company to have propylene glycol plants in two U.S. states in addition to manufacturing sites in Brazil, Germany and Australia.

 

Backed by 60 years of PG expertise and excellent product stewardship, DOW PuraGuard PG USP/EP is produced and handled around the world according to the industry’s most rigorous standards with outstanding quality, supply chain and exceptional solutions in technology and customer service.  More information can be found online by visiting www.dowpg.com.

 

Source: pharmoutsourcing