Scapex Exports Pvt. Ltd.
830, 8th Floor, Sun Gravitas, Times of India Road,
Shyamal, Ahmedabad 380015, Gujarat, India
+91 9925522674 · info@scapexexports.com
CIN U46909GJ2025PTC164345
Shyamal, Ahmedabad 380015, Gujarat, India
+91 9925522674 · info@scapexexports.com
CIN U46909GJ2025PTC164345
Certificate of AnalysisStandard product specification
Chitosan (Nutraceutical Grade)
CAS 9012-76-4 · 90%/95% Deacetylation Nutra Grade
1. Product identity
| Product name | Chitosan (Nutraceutical Grade) |
|---|---|
| C.A.S. number | 9012-76-4 |
| Grade / standard | 90%/95% Deacetylation Nutra Grade |
| Description | White to off-white fine powder |
| Product group | Weight Management Actives |
| Category | Nutraceuticals & Herbal Extracts |
| Country of origin | India |
| Packing | Bags, drums, carboys, IBC or ISO tank as applicable — customer-specified packing available |
| Storage | Cool, dry, well-ventilated place in tightly closed original packing |
2. Analytical specification
| S. No. | Test parameter | Specification | Typical result | Method |
|---|---|---|---|---|
| 1 | Description | White to off-white fine powder | Complies | Visual |
| 2 | Identification | Conforms to the structure of the substance | Complies | FTIR / Chemical test |
| 3 | Solubility | As per specification | Complies | Visual / Monograph |
| 4 | Assay | Not less than 90.0 % w/w | 91.06 | Titrimetry / Instrumental |
| 5 | Loss on Drying | Not more than 5.0 % w/w | 3.07 | Gravimetry |
| 6 | Total Ash | Not more than 5.0 % w/w | 2.55 | Gravimetry |
| 7 | Bulk Density | As per specification | 0.54 g/mL | Tapped density |
| 8 | Particle Size — through 80 mesh | Not less than 95 % | 96.9 | Sieve analysis |
| 9 | Pesticide Residues | Complies with USP <561> | Complies | GC-MS / LC-MS |
| 10 | Aflatoxins (B1, B2, G1, G2) | Not more than 20 ppb | Less than 2 ppb | HPLC-FLD |
| 11 | Residual Solvents | Complies with ICH Q3C | Complies | Headspace GC |
| 12 | Lead (Pb) | Not more than 3.0 ppm | Less than 0.5 ppm | ICP-MS |
| 13 | Heavy Metals (as Pb) | Not more than 10 ppm | Less than 5 ppm | ICP-OES |
| 14 | Total Aerobic Microbial Count | Not more than 1000 cfu/g | 24 cfu/g | IP / USP <61> |
| 15 | Total Yeast & Mould Count | Not more than 100 cfu/g | 19 cfu/g | IP / USP <61> |
| 16 | Escherichia coli | Absent in 1 g | Absent | IP / USP <62> |
| 17 | Salmonella species | Absent in 10 g | Absent | IP / USP <62> |
3. Declaration
This document sets out the standard specification for Chitosan (Nutraceutical Grade) and applies to all consignments of this product and grade supplied by Scapex Exports Pvt. Ltd. It is not a lot-specific release document; a lot-specific certificate carrying the analysis of the material actually shipped is issued with, and travels with, each consignment. Scapex Exports supplies against customer-specified assay limits and pharmacopoeial standards — send your specification sheet and we confirm compliance in writing before the order is accepted.
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