Product Specification - Pancreatin

Product: Pancreas Powder European Pharmacopoeia (Current USP)
Product number:

PAN-01 - PAN-013

Source: pancreas of healthy animals
Production: The animals from which pancreas powder 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.
Product N° PAN-01 PAN-02 PAN-03 PAN-04 PAN-05 PAN-06 PAN-07 PAN-08 PAN-09 PAN-13
Definition 8 x USP 7 x USP 6x USP 5 x USP 4 x USP 3 x USP BP 1 x USP/JP > 8 x USP > 8 x USP Granules
Parameter Specification
Ph. Eur. units/mg:
Lipase
Amylase
Protease
45
42
3.0
39
37
2.6
34
32
2.3
28
26
1.9
22.5
21
1.5
17
15
1.13
20
24
1.4
5.6
5.3
0.4
≥ 55
≥ 50
≥ 3.5
≥ 55
≥ 50
≥ 3.5
≈ USP units/mg:
Lipase
Amylase
Protease
33.0
200
200
28.6
175
175
24.9
150
150
20.5
125
125
16.8
100
100
12.4
75
75
14.6
87.5
93
4.1
25
25
≥ 40
≥ 250
≥ 250
≥ 40
≥ 250
≥ 250
Appearance: a cream-colored, amorphous powder
Identification’s Test according to current European Pharmacopoeia
Particle Size       (mesh):
Sieve test (Ph. Eur. 2.9.12)
100 110 125 140 150 165 150 185 60 30
Bulk density  (kg/Litre):
(Ph. Eur. 2.9.15)
0.67 0.66 0.65 0.64 0.63 0.62 0.64 0.61 0.7 0.3
Solubility (1% Aqua):
(Ph. Eur. 2.2.1)
soluble or partly soluble in water forming a slightly turbid solution; insoluble in organic solvents
Loss on drying:
(Ph. Eur., 2.2.32)
< 5%, at 60 °C, 4 h and 670 Pa
Residue on ignition:
(Ph. Eur., 2.4.14)
< 10%
Fat content (Ph. Eur.) < 5%
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)
≤ 30 ≤ 38 ≤ 45 ≤ 55 ≤ 65 ≤ 75 ≤ 60 ≤ 95 ≤ 16 0

Further quality requirements:

Residual Solvents: according to:
1. current Ph. Eur. 2.4.24., 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%) & Mesityloxid not more than 1000 ppm (< 0.1%)

BSE/TSE:
Pancreas powder 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.). Pancreas powder 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:
Pancreas powder complies with the level of contamination for GMO according to 2003/1830/EU and 2003/1829/EU. Pancreas powder 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:
Pancreas powder 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. Pancreas powder 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 containersPancreas powder 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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