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
Venlafaxine EP Impurity D
Formulated product · EP Reference Standard Grade
1. Product identity
| Product name | Venlafaxine EP Impurity D |
|---|---|
| C.A.S. number | Applicable to blend — on request |
| Grade / standard | EP Reference Standard Grade |
| Description | White to off-white powder |
| Product group | Pharma Reference Standard |
| Category | Laboratory & Analytical Reagents |
| 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 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 | 99.47 | HPLC / Titrimetry (Monograph) |
| 6 | Matter Insoluble in Water | Not more than 0.01 % w/w | 0.0049 | Gravimetry |
| 7 | pH (5 % aqueous solution) | As per specification | 8.0 | Potentiometry |
| 8 | Chloride (Cl) | Not more than 0.001 % | 0.00041 | Turbidimetry |
| 9 | Sulphate (SO4) | Not more than 0.002 % | 0.00046 | Turbidimetry |
| 10 | Iron (Fe) | Not more than 5 ppm | 1.23 ppm | ICP-OES |
| 11 | Heavy Metals (as Pb) | Not more than 5 ppm | Less than 2 ppm | ICP-OES |
| 12 | Loss on Drying | Not more than 1.0 % w/w | 0.31 | Gravimetry (Monograph) |
| 13 | Sulphated Ash / Residue on Ignition | Not more than 0.1 % w/w | 0.028 | Gravimetry (Monograph) |
| 14 | Related Substances — any individual impurity | Not more than 0.10 % | 0.030 | HPLC |
| 15 | Related Substances — total impurities | Not more than 0.50 % | 0.226 | HPLC |
| 16 | Residual Solvents | Complies with ICH Q3C limits | Complies | Headspace GC |
3. Declaration
This document sets out the standard specification for Venlafaxine EP Impurity D 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