Product Specification - Papain

Product: 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
EC number:
CAS-Number: 9001-73-4
Product N° PAP-01 PAP-02 PAP-03 PAP-04 PAP-06 PAP-05 PAP-07
Parameter Specification
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)
100 140 180 200 180 190-150 150-130
Bulk density (kg/Litre):
(Ph. Eur. 2.9.15)
0.3-0.4 0.6 0.7-0.8 0.8-0.6 0.6- 0.5
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
Escherichia coli: absent/g
Staphylococcus aureus: absent/g
Salmonellae: absent/10 g
Added excipient:
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.

Storage conditions:

Shelf life:
Store at 2-8 °C in airtight and light resistant containers Papain is stable up to 2 years.
If stored at temperatures higher than 25 °C, the specific activity should be retested in 3 months intervals.

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