The
United States Pharmacopeia (USP) mandates an animal based assay in rabbits in its Chapter "<121> Insulin Assays" (USP, 2015) for the potency evaluation (biological activity) of insulin and insulin analogs to be imported to the US.
Silpuran 6760/50 meets selected test requirements of ISO 10993 and
United States Pharmacopeia (USP) Class VI.
In:
United States Pharmacopeia 39--National Formulary 34.
Dr Tyle's experience includes service as executive vice president and chief science officer for the
United States Pharmacopeia; senior vice president and global head of research and development & business development and licensing at Novartis OTC; corporate senior vice president of global research and development and chief scientific officer at Bausch + Lomb; and vice president and global head of pharmaceutical sciences at Pharmacia until its acquisition by Pfizer.
Muscat, Dec 20 (ONA) The Ministry of Health, represented by the Directorate General of Medical Supply, organized at the City Seasons Hotel today a workshop on the implementation of the international standards and guidelines for compounding Sterile Preparations according to chapter 797 of the
United States Pharmacopeia (USP).
"This is demonstrated by the fact that Pharmavite was the first vitamin and supplement manufacture to obtain the
United States Pharmacopeia (USP) Dietary Supplement Verification Mark for many of its Nature Made brand products, certifying that the products meet stringent quality criteria set forth by USP."
The company's Marathon diaphragms (which are used in pumps) were certified as
United States Pharmacopeia (USP) Class VI compliant, which means the plastic resin material passed Class VI certification for particular use in medical devices and expected to produce favorable biocompatibility results.
Pure Encapsulations manufactures its own products in an FDA-inspected facility that is NSF-GMP registered in the US and GMP certified in Canada, and exceeds the standards of the
United States Pharmacopeia (USP) for supplement manufacturing.
This move toward greater control of all "temperature-sensitive" drugs is also evident by changes and revisions to existing regulations, guidance and best-practice documents, led by the World Health Organization, the
United States Pharmacopeia, and the Parenteral Drug Association, and in regulations proposed by Health Canada and the International Air Transport Association.
Because of changes in the
United States Pharmacopeia (USP) monograph for heparin products, the potency of heparin will decrease by about 10%, which may require a dose increase and more frequent monitoring.