Vitamin D3100,000 IU/GM

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Vitamin D3100,000 IU/GM, also known as High-Potency Cholecalciferol, is a concentrated form of Vitamin D3 commonly used in pharmaceutical formulations, fortified food products, animal feed, and dietary supplements. This form delivers 100,000 International Units (IU) of cholecalciferol per gram, ensuring efficient delivery of therapeutic or nutritional doses in small volumes. It is produced under stringent quality standards to ensure stability, potency, and safety.

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Category: Active Pharmaceutical Ingredients (APIs) Tags: Cholecalciferol, Fat-Soluble Vitamin, Food & Beverage Industry, Nutraceuticals, Nutritional supplement, Pharmaceuticals, Vitamin D3

Description

Table of Contents

Vitamin D3100,000 IU/GM

Primary Uses

Pharmaceutical Industry

High-Dose Formulations: Used in prescription-only or physician-supervised therapies for the rapid treatment of severe vitamin D deficiencies and disorders like rickets, osteomalacia, or secondary hyperparathyroidism.
Injectables & Capsules: Included in high-strength oral or injectable products for patients requiring therapeutic dosing.
Bone Health Support: Used in conjunction with calcium supplements for osteoporosis treatment and prevention.
Autoimmune & Metabolic Disorders: Explored in therapies for autoimmune diseases (e.g., multiple sclerosis) and insulin sensitivity modulation.

Nutraceuticals & Dietary Supplements

High-Dose Supplements: Formulated in concentrated tablets or soft gels for individuals with clinically diagnosed deficiencies.
Immune System Support: Marketed for boosting immunity, particularly in populations at risk of deficiency (e.g., elderly, obese, or individuals with limited sun exposure).
Therapeutic Nutrition: Used in medical nutrition therapy and customized health regimens.

Food & Beverage Industry

Fortification of High-Nutrition Foods: Used in the enrichment of dairy products, plant-based milks, functional foods, and health drinks, especially where high bioavailability is required.
Infant & Geriatric Nutrition: Incorporated into specialized food products targeting vulnerable populations with higher D3 needs.

Secondary Uses

Veterinary & Animal Nutrition

Feed Additive: Used in poultry, livestock, aquaculture, and pet feed premixes to promote calcium absorption, prevent rickets, and support egg production in layers.
Vitamin Premixes: Blended into multivitamin premixes for veterinary applications in commercial animal husbandry.

Cosmetics & Topical Applications

Skin Creams & Lotions: Occasionally included in skincare products for its anti-inflammatory and skin barrier support roles, though topical bioavailability is limited.

Clinical & Hospital Use

Parenteral Nutrition: Included in injectable nutrition solutions for patients undergoing surgery or receiving long-term intravenous feeding.
Critical Care Nutrition: Employed in high-risk patient groups to rapidly correct deficiencies.

Research & Biotechnology

Hormone Regulation Studies: Used in labs for research on calcium/phosphorus metabolism, endocrine system interaction, and receptor binding.
In Vitro Testing: Included in cell cultures for studies involving vitamin D pathways and immune responses.

KEY PRODUCT FEATURES

1. Basic Identification Attributes

Chemical Name (IUPAC): (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3-ol
Common/Trade Name: Vitamin D3 100,000 IU/gm, Cholecalciferol Concentrate
CAS Number: 67-97-0
HS Code: 2936.29.00
Synonyms: High-potency Cholecalciferol, Vitamin D3 powder, Colecalciferol

2. Physical & Chemical Properties

Physical State: Typically a fine powder or oily concentrate (depending on formulation)
Color & Odor: Off-white to light yellow; odorless or faint odor
Solubility: Fat-soluble; insoluble in water
Potency: 100,000 IU of Vitamin D3 per gram
Stability: Light- and oxygen-sensitive; requires antioxidant and encapsulation for formulation
Melting Point: 83–85 °C
Molecular Formula: C27H44O
Molecular Weight: 384.64 g/mol

3. Safety & Hazard Attributes

GHS Classification: May cause damage to organs through prolonged or repeated exposure at high doses
Toxicity: Low at nutritional levels but can cause hypercalcemia and toxicity if overdosed
Exposure Limits: Avoid excessive inhalation or ingestion of concentrated powder or oil

4. Storage & Handling Attributes

Storage Conditions: Store in a cool, dry place; protect from light, heat, and oxygen
Container Type: Nitrogen-sealed, light-resistant containers (e.g., amber bottles or drums)
Shelf Life: 24–36 months under proper storage
Handling Precautions: Use protective gloves, eye protection, and dust control measures when handling powdered form

5. Regulatory & Compliance Attributes

Complies with: BP, USP, EP, FCC, and food safety standards
GMP-Certified Production: Manufactured under pharmaceutical-grade conditions
Approved for Use In: Human medicine, food fortification, dietary supplements, veterinary applications
Regulatory Status: GRAS (Generally Recognized as Safe) for food use in many countries; widely accepted in health supplements and fortified foods

6. Environmental & Health Impact

Biodegradability: Degradable under environmental conditions
Ecotoxicity: Minimal at nutritional levels
Bioaccumulation: Not expected to bioaccumulate under regulated use

SAFETY HANDLING PRECAUTIONS

Safety Handling Precautions

PPE Required: Gloves, dust mask, safety goggles
Handling Guidelines: Avoid direct contact with skin and mucous membranes; handle under inert or low-light conditions
Storage Measures: Keep container tightly closed and shielded from oxygen and UV light

First Aid Measures

Inhalation: Move to fresh air; seek medical help if symptoms persist
Skin Contact: Rinse with water; seek medical advice for irritation
Eye Contact: Flush eyes thoroughly with water for 15 minutes
Ingestion: Do not induce vomiting; seek immediate medical attention in case of overdose

Firefighting Measures

Fire Hazards: May burn under high heat; combustible in some formulations
Extinguishing Media: Water spray, CO₂, dry chemical
Hazardous Combustion Products: Carbon monoxide, carbon dioxide, and possible toxic fumes