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
Ergocalciferol (Vitamin D2)
CAS 50-14-6 · USP/EP Oily/Powder Grade
1. Product identity
| Product name | Ergocalciferol (Vitamin D2) |
|---|---|
| C.A.S. number | 50-14-6 |
| Grade / standard | USP/EP Oily/Powder Grade |
| Description | White crystalline powder/oily liquid |
| Product group | Fat-Soluble Vitamins |
| Category | Vitamins, Minerals & Amino Acids |
| 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/oily liquid | 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 | Assay (on dried basis) | 98.0 – 102.0 % w/w | 100.35 | HPLC / Titrimetry (Monograph) |
| 5 | Specific Optical Rotation | As per monograph | Conforms | Polarimetry |
| 6 | Loss on Drying | Not more than 0.5 % w/w | 0.26 | Gravimetry |
| 7 | Residue on Ignition | Not more than 0.1 % w/w | 0.042 | Gravimetry |
| 8 | Chloride | Not more than 0.05 % | 0.0128 | Turbidimetry |
| 9 | Lead (Pb) | Not more than 3 ppm | Less than 0.5 ppm | ICP-MS |
| 10 | Heavy Metals | Not more than 20 ppm | Less than 10 ppm | ICP-OES / Limit test |
| 11 | Related Substances — any individual impurity | Not more than 0.10 % | 0.022 | HPLC |
| 12 | Related Substances — total impurities | Not more than 0.50 % | 0.094 | HPLC |
| 13 | Residual Solvents | Complies with ICH Q3C limits | Complies | Headspace GC |
| 14 | Total Aerobic Microbial Count | Not more than 1000 cfu/g | 125 cfu/g | IP / USP <61> |
| 15 | Total Yeast & Mould Count | Not more than 100 cfu/g | 11 cfu/g | IP / USP <61> |
| 16 | Escherichia coli | Absent in 1 g | Absent | IP / USP <62> |
| 17 | Salmonella species | Absent in 10 g | Absent | IP / USP <62> |
3. Declaration
This document sets out the standard specification for Ergocalciferol (Vitamin D2) 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