Acquired two CEPs for Sodium Hyaluronate

2011.12.13

Acquired two CEPs for Sodium Hyaluronate

Sodium hyaluronate(code name: HA-EP1.8 and HA-EP3.0) has respectively acquired the Certificate of Suitability to Monographs of the European Pharmacopoeia(for short as CEP or COS)issued by EDQM in November 2011 (for HA-EP3.0) and December 2011 (for HA-EP 1.8), the certificate type is chemistry, and the certificate number is R0-CEP 2010-289-Rev00 and R0-CEP 2010-290-Rev00. This product is from fermentation, and is intended for themanufacture of intra-ocular preparations or intra-articular preparations, for example ophthalmic viscosurgical device (OVD) and osteoarthritis (OA) injection.

About CEP:

The procedure for ‘Certification of Suitability to the monographs of the European Pharmacopoeia'  was established in 1994 and was in the beginning restricted to controlling the chemical purity of pharmaceutical substances. In 1999, the procedure was extended to include products with a risk of transmissible spongiform encephalopathy (TSE). The procedure was further revised to allow for the control of herbal drugs and herbal drug preparations.