| Customization: | Available |
|---|---|
| CAS No.: | 8049-47-6 |
| EINECS: | 232-468-9 |
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| Product Name: | Pancreatin | ||||
| Testing Standard: | According to Current USP and Customer Standard | ||||
| Source: | Pancreas of Healthy Mammals | ||||
| Packaging : | 25kgs/Drum | Country of Origin: | China | ||
| ITEMS | SPECIFICATIONS | TEST RESULTS | |||
| Appearance | Slightly Brown to Cream Colored Amorphous Powder | Complies | |||
| Solubility | Partly Soluble in Water and Insoluble in Ethanol and Other | Complies | |||
| Fat Content | <6.0% Extraction by Ether | 2.2% | |||
| Loss on Drying | <5.0% in Vacuum at 60ºC 4h | 3.3% | |||
| Specific Activity |
Protease | ≥250 USP.U/mg | 277 USP.U/mg | ||
| Amylase | ≥250 USP.U/mg | 278 USP.U/mg | |||
| Lipase | ≥20 USP.U/mg | 23.2 USP.U/mg | |||
| Microbiological Quality According to Current USP Pharmacopoeia | |||||
| Total Aerobic Microbial Count | <10000cfu/g | 1100cfu/g | |||
| Total Combined Yeast/Moulds Count | <100cfu/g | <10cfu/g | |||
| Bile-Tolerant Gram-Negative Bacteria | <100cfu/g | <10cfu/g | |||
| Escherichia Coli | Absent/g | Absence | |||
| Staphylococcus Aureus | Absent/g | Absence | |||
| Salmonellae | Absent/10g | Absence | |||
| Shelf Life: Stored not exceeding 30ºC in Airtight and light resistant containers, in a Dry place the product is stable for 2 years | |||||
| Re-Test: If stored at temperature higher than 30ºC, the specific activity should be retested in 3 months intervals. | |||||
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