date:Feb 12, 2014
onal performance of a product or the manufacturing process. Customer feed-back was positive, but despite regulatory support for USP 23 parts 87, 88 and ISO10993 it was felt that additional documentation for European Pharmacopeia (EP) was needed. EP monograph 3.1 is restrictive in that only a few substances such as stabilizers are listed. In addition, the test protocols are very different from the above USP and ISO standards. To address this, Clariant recently successfully completed external test