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
Risperidone, European Pharmacopoeia (Ep)
CAS 106266-06-2 · USP/EP
1. Product identity
| Product name | Risperidone, European Pharmacopoeia (Ep) |
|---|---|
| C.A.S. number | 106266-06-2 |
| Grade / standard | USP/EP |
| Description | White to off-white crystalline powder |
| Product group | CNS & Psychiatry |
| 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 to off-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 (on dried basis) | 98.0 – 102.0 % w/w | 99.37 | 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 | 6.9 | Potentiometry |
| 8 | Water Content (Karl Fischer) | Not more than 0.5 % w/w | 0.20 | Karl Fischer titration |
| 9 | Melting Range / Point | As per monograph | Complies | Capillary method |
| 10 | Particle Size (d90) | As per specification | 88 µm | Laser diffraction |
| 11 | Sulphated Ash / Residue on Ignition | Not more than 0.1 % w/w | 0.019 | 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 % | 0.041 | HPLC |
| 14 | Related Substances — total impurities | Not more than 0.50 % | 0.195 | HPLC |
| 15 | Residual Solvents | Complies with ICH Q3C limits | Complies | Headspace GC |
3. Declaration
This document sets out the standard specification for Risperidone, European Pharmacopoeia (Ep) 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