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
Cyclosporine
CAS 59865-13-3 · ≥98% Pure USP/BP
1. Product identity
| Product name | Cyclosporine |
|---|---|
| C.A.S. number | 59865-13-3 |
| Grade / standard | ≥98% Pure USP/BP |
| Description | White crystalline powder |
| Product group | Immunosuppressants |
| Category | Active Pharmaceutical Ingredients (APIs) |
| 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 crystalline 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 | Not less than 98.0 % w/w | 98.29 | HPLC / Titrimetry (Monograph) |
| 6 | Clarity & Colour of Solution | Clear; not more intensely coloured than reference | Complies | Visual (Monograph) |
| 7 | pH (1 % w/v aqueous solution) | As per monograph | 5.4 | Potentiometry |
| 8 | Water Content (Karl Fischer) | Not more than 0.5 % w/w | 0.16 | Karl Fischer titration |
| 9 | Melting Range / Point | As per monograph | Complies | Capillary method |
| 10 | Particle Size (d90) | As per specification | 115 µm | Laser diffraction |
| 11 | Sulphated Ash / Residue on Ignition | Not more than 0.1 % w/w | 0.047 | Gravimetry (Monograph) |
| 12 | Heavy Metals | Not more than 20 ppm | Less than 10 ppm | ICP-OES / Limit test |
| 13 | Related Substances — any individual impurity | Not more than 0.10 % | 0.012 | HPLC |
| 14 | Related Substances — total impurities | Not more than 0.50 % | 0.123 | HPLC |
| 15 | Residual Solvents | Complies with ICH Q3C limits | Complies | Headspace GC |
3. Declaration
This document sets out the standard specification for Cyclosporine 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.
SCAPEXQUALITY ASSURED