Product Overview
Vitamin D3 (cholecalciferol) is a fat-soluble micronutrient synthesized via chemical conversion of lanolin-derived 7-dehydrocholesterol, used as raw material for pharmaceutical, food, and feed fortification applications.
Technical Specifications
|
Parameter Category |
Technical Parameter |
Pure Crystalline |
Vitamin D3 Oil (1,000,000 IU/g) |
Vitamin D3 Powder CWD (100,000 IU/g) |
Test Method |
|
Assay & Potency |
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|
Vitamin D3 Potency |
Vitamin D3 Potency |
97.0% – 103.0% (≈ 38.8 – 41.2 Million IU/g) |
900,000 – 1,100,000 IU/g |
90,000 – 110,000 IU/g |
HPLC |
|
Impurities & Control |
|||||
|
Pre-Vitamin D3 |
Pre-Vitamin D3 |
≤ 1.0% |
≤ 1.0% (of total, HPLC area%) |
- |
HPLC |
|
7-Dehydrocholesterol |
7-Dehydrocholesterol |
≤ 0.5% |
- |
- |
HPLC |
|
Total Impurities |
Total Impurities |
≤ 1.0% |
≤ 2.0% (HPLC total area) |
- |
HPLC |
|
Loss on Drying / Moisture |
Loss on Drying / Moisture |
≤ 0.5% |
- |
≤ 5.0% |
105°C Oven / Karl Fischer |
|
Acid Value |
Acid Value |
- |
≤ 2.0 mg KOH/g |
- |
USP/EP |
|
Peroxide Value (POV) |
Peroxide Value (POV) |
- |
≤ 5.0 meq/kg |
- |
USP/EP |
|
Residual Solvents |
Residual Solvents |
Complies ICH Q3C (Hexane ≤ 290 ppm) |
Complies ICH Q3C |
Complies ICH Q3C |
GC-MS |
|
Contaminants |
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|
Heavy Metals (Total) |
Heavy Metals (Total) |
≤ 10 ppm |
≤ 10 ppm |
≤ 10 ppm |
ICP-MS |
|
Lead (Pb) |
Lead (Pb) |
≤ 0.5 ppm |
≤ 0.5 ppm |
≤ 0.5 ppm |
ICP-MS |
|
Arsenic (As) |
Arsenic (As) |
≤ 0.5 ppm |
≤ 0.5 ppm |
≤ 0.5 ppm |
ICP-MS |
|
Cadmium (Cd) |
Cadmium (Cd) |
≤ 0.2 ppm |
≤ 0.2 ppm |
≤ 0.2 ppm |
ICP-MS |
|
Mercury (Hg) |
Mercury (Hg) |
≤ 0.1 ppm |
≤ 0.1 ppm |
≤ 0.1 ppm |
ICP-MS |
|
Microbiology |
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|
Total Aerobic Count |
Total Aerobic Count |
≤ 1,000 CFU/g |
≤ 1,000 CFU/g |
≤ 1,000 CFU/g |
USP <2021> |
|
Yeasts & Molds |
Yeasts & Molds |
≤ 100 CFU/g |
≤ 100 CFU/g |
≤ 100 CFU/g |
USP <2021> |
|
E. coli |
E. coli |
Negative / 10 g |
Negative / 10 g |
Negative / 10 g |
USP <2022> |
|
Salmonella |
Salmonella |
Negative / 25 g |
Negative / 25 g |
Negative / 25 g |
USP <2022> |
|
Physical Properties |
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|
Particle Size |
Particle Size |
- |
- |
100% through Mesh 40; ≥ 90% through Mesh 60 |
Analytical Sieves |
|
Bulk / Tapped Density |
Bulk / Tapped Density |
- |
- |
0.35 – 0.55 g/mL |
USP <616> |
|
Dispersibility |
Dispersibility |
- |
- |
Dispersible in cold water (15–25°C) within 2 min |
Visual |
Regulatory Compliance & Certifications
Facility Audit Status: FDA-registered manufacturing plant subject to regular third-party compliance inspections.
Global Quality Standards: Production site maintains cGMP, FSSC 22000, and ISO 22000 certifications with USDMF available.
Dietary Compliance: Plant operations hold validated Kosher and Halal supervisory certificates.
Batch Documentation: Every shipment includes comprehensive Certificate of Analysis (COA) and complete technical data.
Regulatory Dossiers: Standard Technical Data Sheets (TDS), MSDS, and EDMF support global regulatory filings.
Manufacturing Facility & Quality Control
Photochemical Synthesis System
UV reactor lines are used to control photoisomerization of lanolin-derived 7-dehydrocholesterol.
Microencapsulation Spray Towers
Specialized nitrogen-sealed spray-drying reduces oxidation risk during CWD microencapsulation.
Potency Protection Controls
Production processes utilize amber lighting and climate-controlled rooms to limit UV degradation exposure.
Chromatographic Purification Technology
Industrial-scale crystallization systems isolate Vitamin D3 isomers to minimize process-related impurities.
Homogeneity Blending Validation
High-precision dilution equipment guarantees Vitamin D3 homogeneity in low-dose premixes.
Dedicated High-Performance Testing
In-house HPLC systems run validated methods specifically calibrated for Cholecalciferol stability assaying.
Packaging, Storage & Logistics Options
|
Aspect |
Technical Specifications & Operations |
|
Primary Packaging |
Triple-layer light-blocking vacuum bags or amber-tinted containers for sensitive Cholecalciferol |
|
Secondary Packaging |
Fiber drums for CWD powder or steel drums for Vitamin D3 oil |
|
Standard Weights |
Concentrated 25 kg bulk drums or customized 1–5 kg high-potency canisters |
|
Atmospheric Guard |
Nitrogen blanket applied during filling to reduce oxidation exposure |
|
Thermal Controls |
Storage maintained below 15°C during warehousing stages |
|
Environmental Guard |
UV-opaque materials used to limit photodegradation risk |
|
Transit Management |
Reefer containers or insulated transport used for temperature stability |
|
Material Compliance |
Packaging selected for compatibility with lipid-based vitamin systems |
FAQ
Q: What measures prevent the isomerization of Vitamin D3 into inactive by-products during processing?
A: Production lines utilize narrow-band UV filters and amber lighting to reduce tachysterol3 and lumisterol3 formation.
Q: Can the cold-water dispersible (CWD) powder withstand mechanical shearing during customer tableting processes?
A: The specialized carbohydrate matrix is designed to protect the embedded lipid core against standard industrial compression forces.
Q: What transit protocols protect winterized lipid shipments from solidifying during cross-border winter transportation?
A: Logistics routes utilize temperature-regulated reefers maintained above crystallization thresholds to ensure constant liquid viscosity.
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