Certificate of Analysis and technical specification for Safinamide — CAS 133865-89-1. Applies to all consignments of this product and grade.
| Product Name | Safinamide |
|---|---|
| C.A.S. Number | 133865-89-1 |
| Product Category | Active Pharmaceutical Ingredients (APIs) |
| Product Group | CNS Drugs |
| Grade / Standard | ≥99% Pharma Grade |
| Physical Form | White to off-white 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 to off-white 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 99.0 % w/w | 99.14 | Titrimetry / Instrumental |
| 5 | Clarity & Colour of Solution | Clear; not more intensely coloured than reference | Complies | Visual (Monograph) |
| 6 | pH (1 % w/v aqueous solution) | As per monograph | 5.8 | Potentiometry |
| 7 | Water Content (Karl Fischer) | Not more than 0.5 % w/w | 0.19 | Karl Fischer titration |
| 8 | Melting Range / Point | As per monograph | Complies | Capillary method |
| 9 | Particle Size (d90) | As per specification | 108 µm | Laser diffraction |
This document sets out the standard specification for Safinamide 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.
