CP Kelco Announces a Family of Products
Compliant to New Pharmacopoeias Specifications
Atlanta, Georgia, USA, May 4, 2011 – In anticipation of customer requirements for products that comply to upgraded and harmonized test methods, CP Kelco has developed a set of products that are compliant to the regulatory requirements specified in the recent initiative to align international pharmacopoeias. In addition to harmonization, the new USP <61> and <62> methods are now more inclusive for more organisms.
CP Kelco’s family of compliant products includes special grades of xanthan gum, pectin and cellulose gum that are tested under the new and expanded microbial requirements.
In order to reduce duplication and the time taken for products to become available in different markets, the Pharmacopoeial Discussion Group (PDG) and the International Conference on the Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) have sought to harmonize the differing regional standards and specifications.
“Considerable time can be saved by selecting products that have already been validated according to the recommended methods in the European and United States Pharmacopoeias, which have been designed to help manufacturers comply with changing regulatory requirements,” states Jane Schulenburg, Global Marketing Director, CP Kelco.
# # #
