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Vitamin D3

Vitamin D3 Manufacturer | High Stability Cholecalciferol (CAS: 67-97-0) Headline: Vitamin D3 (Cholecalciferol) Manufacturer | 100,000 IU/g - 40,000,000 IU/g (CAS: 67-97-0) Sub-info: USP/EP/FCC Grades | Available in Powder (CWS), Oil, and Crystal forms | Non-GMO & Vegetarian Options. USP: • Microencapsulation Tech: Superior stability against light, oxygen, and moisture. • High Potency: Assays ranging from 100,000 IU/g (Food) to 40 MIU/g (Pure Crystal). • Global Compliance: Ready Stock in CN | ISO/GMP/Halal/Kosher Certified.

Introduction


P&K

Vitamin D3 (Cholecalciferol) is the biologically active form of Vitamin D, naturally synthesized in the skin upon sunlight exposure. It is crucial for calcium absorption, bone mineralization, and immune system modulation.

We offer a comprehensive range of Vitamin D3 raw materials to suit various B2B applications:

• Pure Crystal (40 MIU/g): For pharmaceutical R&D and high-potency premixes.

• Vitamin D3 Oil (1 MIU - 4 MIU/g): For softgels and liquid drops.

• CWS Powder (100,000 IU/g - 500,000 IU/g): Cold Water Soluble microencapsulated powder, ideal for functional foods, beverages, and tablets.

Category:

Keywords:

vitamin

manufacturer

cholecalciferol

Functions


1.Bone Health & Calcium Homeostasis

Vitamin D3 facilitates the intestinal absorption of calcium and phosphorus. It is the primary preventive agent against rickets in children and osteomalacia/osteoporosis in adults.

2.Immune System Modulation

Emerging research highlights D3's role in activating T-cells and macrophages, enhancing the body's defense against pathogens and modulating inflammatory responses.

3.Muscle Function

Adequate Vitamin D levels are linked to improved muscle strength and reduced risk of falls in the elderly, making it a key ingredient in senior nutrition formulations.

Applications


1.Dietary Supplements

• Format: Tablets, Hard Capsules, Gummies.

• Solution: Our CWS Beadlets are pressure-resistant, ensuring potency is maintained during the tableting process.

2.Functional Foods & Beverages

• Format: Fortified Milk, Juices, Infant Formula.

• Solution: The Cold Water Soluble (CWS) powder dissolves clearly in liquids without an oily ring or off-taste.

3.Pharmaceuticals & Softgels

• Format: Oil-based Softgels.

• Solution: Our Vitamin D3 Oil (MCT or Corn Oil base) provides excellent bioavailability and precise dosing for softgel manufacturing.

Flow Chart


Ensuring Stability of the Sensitive Active Ingredient

1.Preparation: Dissolving Pure Vitamin D3 Crystal (from Lanolin) in oil carrier.

2.Emulsification: Mixing with hydrocolloids (Starch/Gum Arabic) and antioxidants (dl-alpha-tocopherol).

3.Homogenization: Creating a uniform emulsion.

4.Spray Drying / Spray Cooling: Forming micro-beadlets.

5.Drying: Fluidized bed drying to remove moisture.

6.Sieving: Particle size control (Standard 40-100 Mesh).

7.Quality Control: HPLC Potency Testing & Microbiology.

8.Packaging: Nitrogen-flushed Aluminum bags.

Quality Standard of Lactoferrin


Product: Vitamin D3 Powder 100,000 IU/g CWS (Food Grade)

ItemSpecificationResult
AppearanceWhite to off-white free-flowing powderConforms
Assay (HPLC)90.0% ~ 110.0% of label claim105.0% (Over-age included)
Vitamin D3 Content≥ 100,000 IU/g105,200 IU/g
Loss on Drying≤ 5.0%3.5%
Particle Size100% pass 40 meshConforms
Heavy Metals (Pb)≤ 2.0 ppm0.4 ppm
Arsenic (As)≤ 1.0 ppmConforms
MicrobiologyTotal Plate Count < 1000 cfu/g< 100 cfu/g
Salmonella / E.ColiNegativeNegative

Method of Analysis of Lactoferrin


HPLC (High-Performance Liquid Chromatography)

• Why: We utilize the USP/EP Monograph method (Normal Phase or Reversed Phase HPLC) to accurately quantify Cholecalciferol content. This ensures you are paying for active international units (IU), not just carrier weight.

Reference Chromatogram of Lactoferrin Reference Substance


The chromatogram exhibits a distinct Cholecalciferol peak at the expected retention time, separated from Pre-vitamin D3 and other isomers, confirming the purity and potency of the raw material.

Stability and Safety


Stability Studies

• Challenge: Vitamin D3 is highly sensitive to oxygen and light.

• Our Solution: Double-shell microencapsulation.

• Data:

  ◯ 24 Months Shelf Life: Stored at 25°C in original packaging, potency remains >90%.

  ◯ Stress Test: Retains >80% potency even after 6 months at 40°C (Accelerated conditions), demonstrating excellent stability for global shipping.

Safety & Handling (MSDS Summary)

• Classification: Pure D3 Crystal is Toxic; Diluted Powders (e.g., 100,000 IU/g) are generally safe but require standard PPE.

• Handling: Avoid dust inhalation. Use in well-ventilated areas.

• Storage: Store in a cool, dry place (<25°C). Protect from light. Keep containers strictly sealed.

Long-term stability data of vitamin D3

Vitamin D3 MSDS

Customer Comments


R&D Manager, Functional Beverage Co. (USA)

R&D Manager, Functional Beverage Co. (USA)

2026.02.24

★★★★☆

"Your CWS Vitamin D3 powder has solved our stability issues in beverage applications. The water dispersion is instant and clear."
Procurement Lead, Pharma Manufacturer (Germany)

Procurement Lead, Pharma Manufacturer (Germany)

2026.02.24

★★★★☆

"We source the 40 MIU/g Crystal for our premixes. The assay is consistently high, and the heavy metal control meets our strict EU standards."

Our Certificates


CERTIFICATE

CERTIFICATE

CERTIFICATE

CERTIFICATE

FDA

FDA

ISO

ISO

HALAL

HALAL

HACCP

HACCP

Our Clients


Abbott
Big Bear Pharmaceuticals
Spring season
HIEIDO
Oil and Fat Corporation
Dalian University
China Pharmaceutical University
Shenyang Pharmaceutical University
SIOC
SIMM
KANS
Renhe Pharmaceutical
JNJ
HANHOO
Korea University
Kyeonggi University
LG
Samyang Foods
AJINOMOTO
PipingRock‌
DSM-Firmenich
Beijing Tongrentang
Nestlé
BIOHIGH
Evonik Industries
Herbalife Nutrition
L'ORÉAL
STARFIELD
Unilever
MERCK

Exhibitions


• Vitafoods Europe (Geneva)

• SupplySide West (Las Vegas)

• CPHI Worldwide (Frankfurt/Barcelona)

FIC Shanghai

FIC Shanghai

FIC2024

FIC2024

CPHI Korea

CPHI Korea

SupplySideWEST Las Vegas

SupplySideWEST Las Vegas

SupplySideWEST 2023

SupplySideWEST 2023

Vitafoods Europe Switzerland

Vitafoods Europe Switzerland

Wagri Guangzhou

Wagri Guangzhou

In-Cosmetics Global

In-Cosmetics Global

SupplySide West (Las Vegas)

SupplySide West (Las Vegas)

SupplySide West (Las Vegas)

SupplySide West (Las Vegas)

CPHI & PMEC China 2025

CPHI & PMEC China 2025

CAC 24th

CAC 24th

CAC Shanghai

CAC Shanghai

CPHI & PMEC 2024

CPHI & PMEC 2024

CPHI & PMEC China Shanghai

CPHI & PMEC China Shanghai

CPHI 2025

CPHI 2025

CPHI 2024

CPHI 2024

CPHI 2023

CPHI 2023

FIC 2022

FIC 2022

FIC 2023

FIC 2023

Vitafoods Europe (Geneva)

Vitafoods Europe (Geneva)

CPhI Worldwide

CPhI Worldwide

FAQ


What is the source of your Vitamin D3?

Our standard Vitamin D3 is derived from Lanolin (sheep's wool grease), making it a natural source. We also offer a Vegan Vitamin D3 derived from Lichen or Algae for plant-based formulations.

What is "CWS" and why do I need it?

CWS stands for Cold Water Soluble. Vitamin D3 is naturally fat-soluble. To use it in dry tablets or water-based beverages, we microencapsulate it. This ensures it disperses easily in water and protects the active ingredient from oxidation.

How do you calculate the IU conversion?

1 mcg of Cholecalciferol = 40 IU (International Units). • Example: 25 mcg = 1,000 IU. • Our 100,000 IU/g powder contains 2.5 mg of pure Cholecalciferol per gram.

References


1.Holick, M. F. (2007). Vitamin D deficiency. New England Journal of Medicine.

2.Institute of Medicine (US). (2011). Dietary Reference Intakes for Calcium and Vitamin D.

3.Tripkovic, L., et al. (2012). Comparison of vitamin D2 and vitamin D3 supplementation in raising serum 25-hydroxyvitamin D status: a systematic review and meta-analysis. American Journal of Clinical Nutrition.

4.USP Monograph: Cholecalciferol (Vitamin D3).

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