Pepsin Powder & Pepsin Liquid
Pepsin Powder GMP and Non-GMP
THE OPTIMAL ENZYME FOR PRODUCTION AT LOW PH AND TRICHINELLA DETECTION
For technical applications, pepsin is used in detection assays for Trichinella larvae in meat as required per Regulation (EC) 2015/1375, and is thereby the prescribed test for international trade (1; 2;3;4). Pepsin has multiple purposes in production due to its proteolytic, endopeptidase effects at low pH. In addition, pepsin is used for pharmaceutical and nutraceutical digestive finished formulations, e.g., for treating digestive disorders (1).
BIOFAC’S PEPSIN POWDER
By taking advantages of our 75 years of expertise in the pharmaceutical and nutraceutical industries, BIOFAC produces both GMP and non-GMP certified Pepsin Powder for your research and manufacturing needs:
Pepsin Liquid Non-GMP
THE ENZYME FOR TRICHINELLA DETECTION
For technical applications, liquid pepsin is used in detection assays for Trichinella larvae in meat as required per Regulation (EC) 2015/1375, and is thereby the prescribed test for international trade (1;2;3).
BIOFAC’S PEPSIN LIQUID
By taking advantages of our 75 years of expertise in the pharmaceutical and nutraceutical industries, BIOFAC produces Pepsin Liquid for your research and manufacturing needs:
BIOFAC’S PEPSIN PRODUCTS
BIOFAC Pepsin is available in several grades, complying with all mayor Pharmacopeias:
GMP Pepsin (EU-biological)
- Ph. Eur (undiluted)
- 1:10.000 NF (interim product)
- Ph. Eur (undiluted)
- 1:3000 NF, 1:10.000 NF, 1:20.000 NF (standardized) or customized
- BP or other mayor pharmacopeias
BIOFAC Pepsin Liquid: non-GMP pepsin with activity >660 u/ml
STORAGE AND STABILITY
BIOFAC Pepsin Powder & Pepsin Liiquid should be stored in original and tightly closed containers at room temperature (not exceeding 25°C). Retest date is 2 years from date of production if stored as advised. All products are primarily packed in approved light- and airtight aluminum bags followed by fiber drums.
- BIOFAC Pepsin is cGMP – certified by Danish Health and Medicines Authorities.
- BIOFAC holds a Manufacturer`s Authorisation regarding Human Medicinal Products for Pepsin powder mixed with lactose by Danish Health and Medicines Authorities.
- Danish Environmental Protection Agency (Danish EPA) has made a categorization of BIOFAC as to an instruction No. 6 of 2004 on Differential Environmental Review and assessed that BIOFAC is placed in Category 1 (the best category) because of the high level of systematism and high level of regulatory compliance.
- Danish Working Environment Authority has given BIOFAC a green Smiley, indication that BIOFAC has no issues with the Working Environment Authority, providing a high level of health and safety.
Sources: (1) Sweeney & Walker (1993): Proteolytic Enzymes for Peptide Production, Methods in Molecular Biology: Enzymes of Molecular Biology, Vol. 16, pp. 277-303. (2) Kliegman, M.R. (2020): Trichinellosis (Trichinella spiralis). Nelson Textbook of Pediatrics. Science Direct. (3) Food & Agriculture Organization of the United Nations (2023): Commission Regulation (EC) No. 2075/2005 laying down specific rules on official controls for Trichinella in meat. (4) THE EUROPEAN COMMISION (2015): Commission implementing regulation (EU) 2015/1375 of 10 August 2015 laying down specific rules on official controls for Trichinella in meat. Official Journal of the European Union. L 212/7