Description
The purified crystalline form of Vitamin D3 meeting pharmacopoeial specifications. Used directly in pharmaceutical formulations and as the starting material for pharmaceutical-grade liquid and powder products.
White to off-white crystalline powder. Highly purified by recrystallization from the resin concentrate. Potency typically 40 million IU/g, the highest commercial potency available.
We supply pharmaceutical-grade Vitamin D3 Crystal from manufacturers in China holding ISO, Halal, Kosher and other certifications relevant to the product and production.
Common market grades include USP/BP/EP/JP-compliant crystalline (the workhorse for pharmaceutical use), High-Purity Variant with tighter related-substance tolerances, and pre-blended pharmaceutical premix systems.
Bulk and reduced-MOQ shipments. Batch-level COA covering assay, related substances, specific rotation, melting point, peroxide value, heavy metals, residual solvents, and microbiology.
Introduction
This SKU is the pharmaceutical-grade crystalline form of Vitamin D3, distinct from the resin and oil formats by crystallization-mediated purification and tightened specifications for pharmaceutical use.
Production starts with Vitamin D3 resin, which is recrystallized from suitable solvent under controlled temperature and supersaturation to yield uniform crystalline material. The crystallization step removes related steroids (tachysterol, lumisterol, previtamin D3) that the resin contains, yielding 40 million IU/g pure crystalline cholecalciferol.
Regulatory status: listed in BP, USP, EP, and JP pharmacopoeias as the pharmaceutical Cholecalciferol standard. GRAS in the U.S.; approved by major regulators worldwide for pharmaceutical and food fortification use.
The crystalline format is the highest-purity Vitamin D3 commercially available. Pharmaceutical manufacturers use it directly in tablet, capsule, and injectable formulations. Dietary supplement manufacturers use it for premium-positioned products where pharmaceutical-grade specifications are part of the value proposition.
Strategic positioning serves pharmaceutical and premium supplement manufacturing specifically. Cost per IU is meaningfully higher than oil or feed-grade formats, but the pharmaceutical-grade specifications justify the premium for regulated finished-product applications.
Where it is used
- Pharmaceutical Vitamin D3 manufacturing: tablets, capsules, soft gels, oral drops, injectable preparations
- High-potency dietary supplement manufacturing
- Clinical nutrition and parenteral nutrition formulations
- Premium fortified-food and beverage Vitamin D3 systems
- Cosmetic and skincare formulations requiring pharmaceutical-grade purity
- Pharmaceutical research and clinical study supplies
- Veterinary pharmaceutical high-grade formulations
Technical data
| Item | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Assay (HPLC, dry basis) | 97.0% to 103.0% |
| Potency | 40,000,000 IU/g |
| Specific rotation | +105° to +112° |
| Melting point | 84 °C to 88 °C |
| Related substances | ≤ 1.0% |
| Heavy metals (as Pb) | ≤ 5 mg/kg |
| Residual solvent | Within ICH limits |
| Pharmacopoeial standards | USP / BP / EP / JP |
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