Colecalciferol, also known as Cholecalciferol or Vitamin D3, is a fat-soluble vitamin and pharmaceutical active ingredient used in vitamin D supplementation and pharmaceutical formulations. It is a secosteroid compound with the molecular formula C₂₇H₄₄O and molecular weight 384.64 g/mol.
Colecalciferol is an important pharmaceutical ingredient used in formulations designed to provide Vitamin D3. It is available in different pharmaceutical and nutritional preparations, including formulations where controlled Vitamin D3 content is required.
Colecalciferol API is supplied for pharmaceutical formulation, manufacturing and development applications. The material can be evaluated for identity, assay, purity and other relevant pharmaceutical quality characteristics using appropriate analytical procedures.
Colecalciferol is used as a source of Vitamin D3 in pharmaceutical and nutritional formulations. It is incorporated into formulations where Vitamin D supplementation is required.
Colecalciferol quality testing may include identification, assay, specific optical rotation, related substances, residual solvents and other applicable quality parameters. USP provides dedicated analytical procedures for Vitamin D and recognizes USP Cholecalciferol Reference Standard for testing.
Colecalciferol should be protected from light and air and stored in a tightly closed container under the conditions specified by the applicable product specification. Its sensitivity to light and air makes appropriate packaging and handling important.
Colecalciferol API can be supplied to qualified pharmaceutical manufacturers, formulation companies, distributors and other approved customers. Product specifications, CoA, SDS and technical documentation can be provided according to applicable requirements.
| Parameter | Specification |
|---|---|
| Identification | Conforms by IR/UV and chromatographic identification |
| Assay (HPLC) | 97.0% – 103.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Melting Point | Approximately 84–85°C |