Vitamin D3

Description

1. Product Overview

Vitamin D3 (cholecalciferol) is a high-purity fat-soluble secosteroid used broadly as an active ingredient and fortifier across pharmaceutical, nutraceutical, animal feed, and food-fortification supply chains. Its primary industrial use is as a standardized source of biologically active vitamin D for formulation into tablets, capsules, softgels, premixes, fortified foods, and veterinary supplements. The product delivers consistent potency, excellent stability in oil and dry-matrix formulations, and predictable bioavailability — reducing formulation variability and regulatory risk. Strategically, Vitamin D3 is mission-critical for manufacturers addressing global public health mandates, age-related supplementation demand, and fortified-food programs, making it a high-priority raw material for long-term supply agreements.

2. Key Specifications & Technical Characteristics

• Chemical composition: Cholecalciferol (Vitamin D3), chemical formula C27H44O.

• Active content / potency: Typically supplied at technical-grade potency (IU/g or µg/g) per buyer specification; available standard concentrations for formulation.

• Purity/assay: >98% (HPLC), typical pharma/nutra technical grade; certificates of analysis provided for each batch.

• Impurities: Specified and controlled per pharmacopeial or customer specifications (e.g., limits for related sterols, solvents).

• Physical form: Off-white to pale yellow crystalline powder or viscous oil solution (customer-specified carriers).

• Particle size (powder): Supplied to meet flow and blending requirements; typical D50 range 10–60 µm (custom milling available).

• Bulk density (powder): Typically 0.25–0.60 g/cm3 depending on grade and carrier.

• Solubility: Practically insoluble in water; soluble in oils, ethanol, and organic solvents; designed for oil-based encapsulation or dry premix dispersion with carriers.

• Stability: Stabilized against oxidation with appropriate packaging; recommended storage below 25°C, protected from light and moisture.

• Shelf life: 12–36 months depending on formulation and packaging; stability data and accelerated aging reports available on request.

• Packaging options: 25 kg fiber drums (lined), 200 kg steel drums (lined), ISO tank/IBC for oil solutions, and custom packaging for GMP/pharma customers.

• Regulatory support: Batch COA, SDS, GMP declaration (if applicable), and documentation to support food/pharma compliance available.

3. Core Industrial Applications

• Pharmaceuticals: Active ingredient or excipient in tablets, capsules, and liquid formulations for human therapeutic and OTC vitamin D preparations. Use: standardized dosing, stable incorporation into oil-based softgels or dry blends for controlled release. Advantage: high assay and low impurity profile reduce batch rejects and regulatory review time.

• Nutraceuticals & Dietary Supplements: Primary ingredient in tablets, softgels, chewables, and liquid drops. Use: provides verified potency and consistent bioavailability for branded and private-label products. Advantage: minimal taste/odor profile and compatibility with common excipients.

• Food Fortification & Beverage Manufacturing: Used to fortify dairy, plant-based milks, margarine, and cereal flours. Use: microencapsulated or oil-dispersed forms enable uniform distribution and stability in processing. Advantage: enhanced retention through heat and shelf-life compared with lower-grade sources.

• Animal Feed & Veterinary: Fortification of feed premixes and medicated feeds for poultry, swine, and aquaculture. Use: supports bone health, growth performance, and egg-quality programs. Advantage: predictable dosing reduces variability in production metrics.

• Contract Manufacturing & Co-packing: Raw material for CMOs producing consumer healthcare goods. Use: consistent lot-to-lot quality simplifies validation and scale-up. Advantage: reduces downtime and rework during transfer of manufacture.

4. Competitive Advantages

• Quality consistency: Batch-to-batch assay >98% with traceable COAs and in-house QC (HPLC, impurity profiling).

• Supply reliability: Strategically diversified manufacturing and inventory buffers to support long-term contracts and emergency replenishment.

• Logistics capability: Global shipping solutions (FCL, LCL, ISO tank) with export documentation, customs-classification support, and temperature/light-protected handling.

• Price competitiveness: Industrial-scale production enables competitive unit pricing for bulk purchasers and structured volume discounts.

• Sustainability: Manufacturing processes optimized for solvent recovery and waste minimization; supplier transparency on raw-material sourcing available for ESG assessments.

• Technical support: Formulation guidance, stability data, and compatibility testing available to reduce product development time and regulatory queries.

• Documentation: Full regulatory dossier support (COA, SDS, GMP declarations, stability summaries) to expedite qualification and audit processes.

5. Commercial & Supply Information

• Minimum order quantity (MOQ): BULK 20 MT.

• Loading capacity (MT per container):

  • 20-foot container (standard palletized drums): up to ~18–20 MT depending on drum size and packing configuration.

  • 40-foot container (standard palletized drums): up to ~22–24 MT depending on drum size and packing configuration.

  • ISO tank/IBC (for oil solutions): up to 20–24 MT depending on product density and tank availability.