Certificate of Analysis and technical specification for Ethinylestradiol — CAS 57-63-6. Applies to all consignments of this product and grade.
| Product Name | Ethinylestradiol |
|---|---|
| C.A.S. Number | 57-63-6 |
| Product Category | Active Pharmaceutical Ingredients (APIs) |
| Product Group | Hormonal APIs |
| Grade / Standard | USP/EP ≥99% |
| Physical Form | White crystalline 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 | 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 99.0 % w/w | 99.23 | 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 | 6.5 | Potentiometry |
| 8 | Water Content (Karl Fischer) | Not more than 0.5 % w/w | 0.10 | Karl Fischer titration |
| 9 | Melting Range / Point | As per monograph | Complies | Capillary method |
| 10 | Particle Size (d90) | As per specification | 183 µm | Laser diffraction |
| 11 | Sulphated Ash / Residue on Ignition | Not more than 0.1 % w/w | 0.056 | 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 % | 0.013 | HPLC |
| 14 | Related Substances — total impurities | Not more than 0.50 % | 0.120 | HPLC |
| 15 | Residual Solvents | Complies with ICH Q3C limits | Complies | Headspace GC |
This document sets out the standard specification for Ethinylestradiol 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.
