Certificate of Analysis and technical specification for Papain Enzyme — CAS 9001-73-4. Applies to all consignments of this product and grade.
| Product Name | Papain Enzyme |
|---|---|
| C.A.S. Number | 9001-73-4 |
| Product Category | Nutraceuticals & Herbal Extracts |
| Product Group | Digestive Enzyme Actives |
| Grade / Standard | 2000 USP U/mg Nutra Grade |
| Physical Form | Off-white to light tan powder |
| Country of Origin | India |
| Packing | Standard export packing — bags, drums, carboys, IBC or ISO tank as applicable |
| Storage | Cool, dry, well-ventilated place in tightly closed original packing |
| S. No. | Test Parameter | Specification | Typical Result | Method |
|---|---|---|---|---|
| 1 | Description | Off-white to light tan powder | Complies | Visual |
| 2 | Identification (A) — Infrared absorption | Concordant with reference spectrum | Complies | IR Spectrophotometry |
| 3 | Identification (B) — Chemical / chromatographic | Positive for the substance | Complies | As per monograph |
| 4 | Solubility | As per specification | Complies | Visual / Monograph |
| 5 | Assay (on dried basis) | 98.0 – 102.0 % w/w | 99.02 | HPLC / Titrimetry (Monograph) |
| 6 | Loss on Drying | Not more than 5.0 % w/w | 1.69 | Gravimetry |
| 7 | Total Ash | Not more than 5.0 % w/w | 1.86 | Gravimetry |
| 8 | Bulk Density | As per specification | 0.38 g/mL | Tapped density |
| 9 | Particle Size — through 80 mesh | Not less than 95 % | 96.0 | Sieve analysis |
| 10 | Pesticide Residues | Complies with USP <561> | Complies | GC-MS / LC-MS |
| 11 | Aflatoxins (B1, B2, G1, G2) | Not more than 20 ppb | Less than 2 ppb | HPLC-FLD |
| 12 | Residual Solvents | Complies with ICH Q3C | Complies | Headspace GC |
| 13 | Lead (Pb) | Not more than 3.0 ppm | Less than 0.5 ppm | ICP-MS |
| 14 | Sulphated Ash / Residue on Ignition | Not more than 0.1 % w/w | 0.050 | Gravimetry (Monograph) |
| 15 | Heavy Metals | Not more than 20 ppm | Less than 10 ppm | ICP-OES / Limit test |
| 16 | Related Substances — any individual impurity | Not more than 0.10 % | 0.052 | HPLC |
| 17 | Related Substances — total impurities | Not more than 0.50 % | 0.229 | HPLC |
| 18 | Total Aerobic Microbial Count | Not more than 1000 cfu/g | 108 cfu/g | IP / USP <61> |
| 19 | Total Yeast & Mould Count | Not more than 100 cfu/g | 8 cfu/g | IP / USP <61> |
| 20 | Escherichia coli | Absent in 1 g | Absent | IP / USP <62> |
| 21 | Salmonella species | Absent in 10 g | Absent | IP / USP <62> |
This document sets out the standard specification for Papain Enzyme and applies to all consignments of this grade. It is not a lot-specific release document; a lot-specific certificate carrying the analysis of the material actually shipped is issued with each consignment. Scapex Exports supplies against customer-specified assay limits and pharmacopoeial standards — send your specification sheet and we will confirm compliance before order.
Send the specification you work to — we confirm the grade, packing, documentation set and CIF/FOB price within one business day.
