1) Pancreatin IP
2) Pancreatin IP granules
3)Pancreatin 4NF
4) Pancreatin 4NF granules
5)Pancreatin 8NF
1) Pancreatin IP2) Pancreatin IP granules3)Pancreatin 4NF4) Pancreatin 4NF granules5)Pancreatin 8NF
ertificate of Analysis
Name of Product | Pancreatin |
Batch No | 110944 | Date of test | Oct 28, 2011 |
Quantity | 100kg |
Manufactured Date | Oct 28, 2011 | Expiry Date | Sptember, 2013 |
Test Items | Specifications EU 7.1 | Results | Identification | A: Protelytic activity test: should comply B: Amylolytic activity test: should comply | Complies | Partical size | NMT 80 mesh | Complies | Appearance | A slightly brown of off white powder | complies | Activity | Protease > 3.8 PH Eur.u /mg Amylase > 58.0 PH Eur.u /mg Lipase > 60.0 PH Eur.u /mg | 3.9 PH Eur.u /mg 58.6PH Eur.u /mg 60.5 PH Eur.u /mg | Fat content | ≤5.0% | 1.0% | Loss on drying | ≤5.0% | 4.0% | Identification | conforms | conforms | Solubility | Partly soluble in water, insoluble in ethanol and other | Complies | Total bacteria count | 10000/g | 10/g | Yeast and Moulds | 100/g | 10/g | E.Coli | Negative | Negative | Salmonellae | Negative | Negative |
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Pancreatin IP granules, 4NF granules, 8NF granules, 6NF