Product Specification - Chymotrypsin
|Product number:||CHY-01 - CHY-04|
|Systematic name:||Peptidyl peptide hydrolase|
|Molecular weight:||Chymotrypsin: approx. 25,000 daltons; Trypsin: approx. 23,500|
|Production:||According to current European Pharmacopoeia: The animals from which chymotrypsin / 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||≥ 300||280||200|
|Content on Trpysin
|< 25||< 25||< 25||1000|
|Appearance||White to tan, odourless crystalline or amorphous, hygroscopic powder|
|Identification||Complies the specific activity|
|Bulk density (kg/Litre)||0.3||0.4-0.5|
|Solubility||An amount, equivalent to 100,000 USP Chymotrypsin units, is soluble in 10 ml of water and in 10 ml of saline TS.|
|pH (1% Aqua):||3.0-5.0|
|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)
|≤ 15%||≤ 20%||≤ 45%||≤ 50%|
Further quality requirements:
Residual Solvents: according to:
current Ph. Eur. 5.4. & 2.4.24., (By GC), 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%)
Chymotrypsin 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. Chymotrypsin 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.
Chymotrypsin complies with the level of contamination for GMO according to 2003/1830/EU and 2003/1829/EU. Chymotrypsin 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.
Chymotrypsin complies with the EU Directive 2003/89/EC of the European Parliament and the European Council dated 10 November 2003 concerning the Amendment of the Directive 2000/13/EC (directive on labelling). Chymotrypsin does not contain allergens listed in Annex IIIa of EU Directive.