Pfanstiehl has announced the launch of the first cGMP Sodium Succinate Hexahydrate (NF) to the market, which is compliant with the new USP Monograph established in 2017. Pfanstiehl previously launched the first cGMP Sodium Succinate Anhydrous (NF) to the market in March 2018.
This is the only available cGMP grade Sodium Succinate Hexahydrate (#D-161) product available on the market. It is highly pure, has low endotoxin and is manufactured in the US under strict ICH Q7 compliant conditions.
Sodium Succinate Hexahydrate is generally used as a Biopharmaceutical ingredient for pH buffering and final product formulation e.g. ADCs, liposomal drug delivery systems etc. Alternative chemical names are Disodium succinate hexahydrate, Disodium butanedioate hexahydrate, Butanedioic acid disodium salt hexahydrate, Succinic acid disodium salt hexahydrate, Sodium succinate dibasic hexahydrate.
As part of Pfanstiehl’s continual commitment to producing the industry’s highest purity, lowest endotoxin and lowest metals for bioprocessing components, the Sodium Succinate Hexahydrate specification includes ICH Q3D Elemental Impurity Data which is backed by extensive product characterization data.
Pfanstiehl’s market-leading specifications for the new Sodium Succinate Hexahydrate help to provide product quality and consistency for better support with biopharmaceutical processing requirements.
Commercial material and samples from Pfanstiehl’s cGMP manufactured batches of Sodium Succinate Hexahydrate are available now for customer qualification and production, along with a Product Profile.
Pfanstiehl is the market leader of high purity, low endotoxin-low metal carbohydrates for biologics, biosimilars, vaccines, cell culture media and injectable (liquid and lyophilized) formulations and supplies its products to nearly all of the leading global biopharmaceutical companies. Pfanstiehl has manufactured parenteral grade excipients for more than 50 years, and Pfanstiehl’s excipients are critical formulation components in the majority of the top ten global blockbuster biopharmaceutical drugs which have been administered to thousands of patients around the world. Pfanstiehl’s high purity, low endotoxin-low metal Excipient products are known as “best in class” due to their high purity, performance, consistency and quality attributes.
Known for nearly a century for its first-in-class carbohydrate chemistry expertise, Pfanstiehl has built a market leading reputation for supplying high quality, cGMP-produced excipients from its US headquarters north of Chicago.