Product Specification - Trypsin
|Product number:||TRY-02 - TRY-07|
|Source:||Ox, Bos taurus Linné (Fam. Bovidae) or porcine pancreas|
|Systematic name:||Peptidyl peptide hydrolase|
|Molecular weight:||Trypsin: approx. 23,500, Trypsin: approx. 25,000 daltons;|
|Production:||According to current European Pharmacopoeia: The animals from which Trypsin / Trypsin is derived fulfil the requirements for the health of animals suitable for human consumption to the satisfaction of the competent authority; furthermore the tissues used do not include any specified risk material as defined by relevant international legislation. The method of production allows inactivation and removal of any contamination by viruses or other infectious agents. The method of manufacturing is validated.|
|Ph. Eur. units/mg||> 35||≈ 30||≥ 30|
|USP units/mg||3200||2500||> 2500||2400||900||1200|
|Content on Chymotrypsin
|< 50||< 50||< 50||400||150||300|
|Appearance||White to tan, odourless crystalline or amorphous, hygroscopic powder|
|Identification||Complies the specific activity|
|Bulk density (kg/Litre)
(Ph. Eur. 2.9.15)
|Solubility||An amount, equivalent to 500,000 USP Trypsin Units, is soluble in 10 ml of water and in 10 ml of saline TS|
|pH (1% Aqua): (Ph. Eur. 2.2.3)||3.0-6.0|
|Loss on drying: (Ph. Eur., 2.2.32)||< 5% at 60 °C, 4 h and 0.7 kPa|
|Residue on ignition:
(Ph. Eur., 2.4.14)
|Microbiological quality||according to current European Pharmacopoeia (5.1.4, 2.6.12 & 2.6.13)|
|Total aerobic microbial count (TAMC):||<104/g|
|Total combined yeast / moulds count (TYMC)||<102/g|
|Bile-tolerant gram-negative bacteria||<102/g|
|Added Sorbitol Ph. Eur.
as excipient: % (m/m)
|≤ 10%||≤ 30%||≤ 30%||≤ 10%||≤ 65%||≤ 55%|
Further quality requirements:
Residual Solvents: according to:
1. current Ph. Eur. 5.4. & 2.4.24. (Headspace GC / FID) 2. CPMP/QWP/450/03 corr. and EMEA/CVMP/511/03 annexes to CPMP/ICH/283/95 (International Conference on Harmonisation; Guidance on Impurities)
No Solvents from groups 1 & 2. From group 3 (Acetone) not more than 5000 mg/kg (< 0.5%)
Trypsin complies with the Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products (EMEA/410/01-Rev.1) in line with 2001/82/EC and 2001/83/EC (Ph. Eur. 5.2.8.). Trypsin has not been manufactured from a raw material of origins with TSE/BSE-Risk. It does not contain compounds manufactured from a raw material of origins with TSE/BSE-Risk.
Trypsin complies with the level of contamination for GMO according to 2003/1830/EU and 2003/1829/EU. Trypsin has not been manufactured from a raw material of genetically modified origin and does not contain compounds manufactured from other GMO products and their Derivatives.
Trypsin complies with the COMMISSION DIRECTIVE 2006/142/EC of 22 December 2006 amending Annex IIIa of Directive 2000/13/EC of the European Parliament and of the Council listing the ingredients which must under all circumstances appear on the labelling of foodstuffs. Trypsin does not contain allergens listed in Annex IIIa of EU Directive.