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: