Product Specification - Papain
|Product number:||PAP-01 - PAP-07|
|Source:||Latex from the fruit of Cairia papaya Linné.|
|Systematic name:||Peptidyl peptide hydrolase|
|Molecular weight:||23,400 daltons|
|USP units/mg||≥ 45,000||30,000||6000||3000-4000||≥ 8000|
|≈ FIP units/mg||3.7||2.5||0.5-2.5||2.5-3.5|
|Appearance:||White amorphous, hygroscopic powder|
|Identification’s Test||Skim milk reaction|
|Particle Size (mesh):
Sieve test (Ph. Eur. 2.9.12)
|Bulk density (kg/Litre):
(Ph. Eur. 2.9.15)
|Solubility (2% Aqua):
(Ph. Eur. 2.2.1)
|Soluble in water, the solution being colourless to light yellow and more or less opalescent; practically insoluble in organic solvent|
|pH (2 % Aqua):
(Ph. Eur. 2.2.3)
|Loss on drying:
(Ph. Eur., 2.2.32)
|< 5% at 60 °C, 4 h and 0.7 kPa|
|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|
Lactose Ph. Eur.% (m/m)
|25||≤ 50||≤ 90||≤ 95||≤ 85||95 - 65||65 - 45|
Further quality requirements:
Residual Solvents: according to:
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 and 3.
Papain 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.). Papain 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.
Papain complies with the level of contamination for GMO according to 2003/1830/EU and 2003/1829/EU. Papain 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.
Papain 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. Papain does not contain allergens listed in Annex IIIa of EU Directive.