Vitamin D3 Crystal Pharma Grade
Vitamin D3 Crystal Pharma Grade is high-purity cholecalciferol sold as white to pale-yellow needle crystals with assay above 99 percent, meeting USP and European Pharmacopoeia monographs.
This is the form used when downstream chemistry, dosing precision, or label positioning will not tolerate a carrier matrix. It is the starting material for pharmaceutical drug products, infant-nutrition fortification mixes, sterile injectables, and premium dietary supplements that quote a refined-active spec.
We source bulk Vitamin D3 Crystal Pharma Grade from top China manufacturers for our partners, working with several of them. The manufacturers are in Zhejiang and Jiangxi. A smaller requirement can ship in a combined container with other ingredients.
Please send the grade you need, the volume and your destination port, and we will come back with a solution and a price.
or call +86-21-6858 0751
- Packaging
- 25 kg kraft paper bag with PE inner liner
- ISO 9001
- HACCP
- Halal
- Kosher
Specifications
Grades / Types Available: Pharmaceutical Grade
| Item | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Assay (HPLC) | 97.0% - 103.0% (40,000,000 IU/g) |
| Specific Rotation [α]D20 | +105° to +112° |
| Melting Point | 84°C - 88°C |
| Loss on Drying | ≤ 0.5% |
| Heavy Metals (as Pb) | ≤ 10 ppm |
| Arsenic (As) | ≤ 1 ppm |
| Residue on Ignition | ≤ 0.1% |
| Pre-Vitamin D3 | ≤ 2.0% |
| Purity/Assay | ≥ 98% |
| Moisture/Loss on Drying | ≤ 5% |
| pH | 6.0 - 7.5 |
| Lead | ≤ 2 ppm |
| Total Plate Count | ≤ 1000 cfu/g |
| Yeast & Mold | ≤ 100 cfu/g |
Common Markets Grades
Pharma-grade crystal is produced against pharmacopoeial assays, typically 99.0 to 101.0 percent of label as cholecalciferol on the dried basis.
Related-substance limits, specific optical rotation, melting range, and absorbance ratios are all controlled per monograph. Lot-to-lot reproducibility against a USP or Ph. Eur. reference standard is what distinguishes pharma grade from food-grade or feed-grade crystalline material.
Material is packed in amber glass or HDPE bottles under nitrogen, with desiccant, and held under refrigeration. Subdivision into single-use ampoules is produced for analytical and reference-standard applications.
Applications
- Prescription and over-the-counter vitamin D drug products in capsule, tablet, and oral-drop form
- Sterile injectable D3 preparations for hospital and veterinary use
- Infant formula and follow-on nutrition where pharmacopoeial identity is required
- Medical nutrition for malabsorption, renal, and post-bariatric patient populations
- High-dose D3 single-pearl softgels (50,000 IU and above)
- Combination osteoporosis therapies pairing D3 with calcium salts or bisphosphonates
- Premium dietary supplements positioned around USP or Ph. Eur. compliance
- Analytical reference and quality-control standards for assay validation
- Custom syntheses of D3 metabolites such as calcifediol and calcitriol
- Sterile compounding pharmacy preparations
Brands Using Vitamin D3 Crystal Pharma Grade
Widely-distributed consumer products that list Vitamin D3 Crystal Pharma Grade on the ingredient label.
- Empower PharmacyCompounded Cholecalciferol (Vitamin D3) Capsules ↗Empower Pharmacy, an accredited 503A / FDA-registered 503B compounding pharmacy, compounds prescription cholecalciferol capsules from high-purity pharma-grade D3 active ingredient.Label verified 2026-05-24
- Empower PharmacyCompounded Cholecalciferol (Vitamin D3) Injection ↗Empower Pharmacy's compounded cholecalciferol intramuscular injection is a prescription pharma application requiring high-purity crystalline D3 as the API source.Label verified 2026-05-24
Brand names, product names and logos are the property of their owners. They appear here as published evidence that the ingredient is used, taken from the brand's own label or website. Their appearance is not an endorsement, and it does not mean the brand buys from us or from any manufacturer listed on this site.
China Manufacturers of Vitamin D3 Crystal Pharma Grade
Top Vitamin D3 Crystal Pharma Grade manufacturers in China.
Jiangxi Tianxin Pharmaceutical Co., Ltd.16 ingredients in the directory
Zhejiang NHU Company Ltd.25 ingredients in the directory
Zhejiang Tianhecheng Bio-technology Shares Co., Ltd.17 ingredients in the directory
Zhejiang Wedin Biological Technology Co., Ltd.18 ingredients in the directory
Zhejiang Weishi Biotechnology Co.,;Ltd.5 ingredients in the directory
Company names and logos are the property of the manufacturers themselves. They are listed here because our own directory records them as producing this ingredient. A listing is not an endorsement by them, and we do not represent them or speak on their behalf.
How We Help Source Vitamin D3 Crystal Pharma Grade
Direct Factory Sourcing
We run the whole process: selecting the manufacturer from the top Chinese food ingredient producers, negotiating the price, verifying quality, and coordinating the logistics. You deal with us instead of with several factories at once.
Original Packaging and Documents from the Manufacturer
The manufacturer sends your Vitamin D3 Crystal Pharma Grade out of its own factory in the original packing, through to your destination port. The COA, COO, MSDS, TDS and any certifications reach you from the manufacturer as well.
Free Samples and Lead Time
We send 100 to 500 g free for your own laboratory to test and you cover only the courier, usually within 2 to 3 working days. ETD is usually within 7 to 15 days once the order is confirmed, and we check that date against the factory's own manufacturing schedule before we give it to you.
Combined Shipment
We can load Vitamin D3 Crystal Pharma Grade together with other ingredients such as Vitamin C, Vitamin D3 and Vitamin E into one 20' FCL. If your quantity is small, we can also ship LCL.
Regulatory Status
Cholecalciferol monographs are published in USP, Ph. Eur., Japanese Pharmacopoeia, and BP, and the four texts are closely harmonised on identity and assay.
For pharmaceutical use the material must originate from a facility holding ICH Q7 GMP certification, with a current Drug Master File or Certificate of Suitability filed with the relevant regulator. EDQM CEPs are routinely held by the major producers.
For infant nutrition the additional layer is Codex Alimentarius Standard 72-1981 plus the EU infant-formula regulation, both of which call for pharmacopoeial-quality D3. Documentation typically extends to TSE/BSE statements covering the lanolin source.
Manufacturing Process
Pharma-grade crystal is the most refined output of the cholecalciferol value chain. Crude resin from the UV irradiation of 7-dehydrocholesterol is taken through molecular distillation to strip pre-vitamin D, lumisterol, tachysterol, and other photoisomers.
The purified concentrate is crystallised from a methanol or methyl formate solvent system under controlled cooling. Recrystallisation is repeated until the related-substance profile meets monograph limits, then the cake is washed cold, vacuum-dried, and packed under inert atmosphere.
Release testing covers HPLC assay, specific rotation, IR identity, residual solvents, heavy metals, and microbiology. Reference-standard material is additionally cross-checked against a pharmacopoeial primary standard.
