Product Specification - Pepsin

Product: Pepsin
Product number: PEP-01 - PEP-06
Source: gastric mucosa of pigs
Systematic name: Peptidyl peptide hydrolase
Molecular weight: 34,500 Daltons
EC number: 3.4.23.1
CAS-Number: 9001-75-6
Product N° PEP-01 PEP-02 PEP-03 PEP-04 PEP-05 PEP-06
Parameter Specification
Ph. Eur. units/mg 2.5 1.6 0.5 1.3 0.4 0.5-3.5
≈ NF 1:15000 1:10000 1:3000      
≈ BP       1:10000 1:3000  
Appearance: White or slightly yellow, crystalline or amorphous, hygroscopic powder
Identification: Complies the Haemoglobin-digestive characteristic
Particle Size (mesh):
Sieve test (Ph. Eur. 2.9.12)
70 80 90 85 95 90-60
Bulk density   (kg/Litre):
(Ph. Eur. 2.9.15)
0.70 0.60 0.65 0.60 0.6-0.8
Solubility (1% Aqua):
(Ph. Eur. 2.2.1)
Partly Soluble in water; insoluble in organic solvent
Appearance of Solution: Slightly opalescent with a weak acidic reaction
pH (1% Aqua):
(Ph. Eur. 2.2.3)
3.0-5.0
Loss on drying:
(Ph. Eur., 2.2.32)
< 5% at 60 °C, 4 h and 670 Pa
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:
Maltodextrin Ph. Eur. (GMO-free)
% (m/m)
≤ 35% ≤ 60% ≤ 87% ≤ 66% ≤ 90% ≤ 90-0%

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%)

BSE/TSE:
Pepsin 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.). Pepsin 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.

GMO:
Pepsin complies with the level of contamination for GMO according to 2003/1830/EU and 2003/1829/EU. Pepsin 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.

Allergens:
Pepsin complies 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. Pepsin 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.Pepsin is stable up to 2 years.
Re-Test:
If stored at temperatures higher than 25 °C, the specific activity should be retested in 3 months intervals

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