Product Overview
Thiamine Hydrochloride is a water-soluble hydrochloride salt form of vitamin B1 used in food, supplement, and pharmaceutical formulations.
Technical Specifications
|
Category |
Parameter |
Typical Value / Specification |
|
Physical Constants |
Appearance |
White to off-white crystalline powder or colorless crystals |
|
Melting Point |
Approx. 248°C–250°C (with decomposition) |
|
|
Solubility (20°C) |
Freely soluble in water, slightly soluble in ethanol, practically insoluble in ether |
|
|
Specific Rotation |
+11.2° to +11.5° |
|
|
Chemical Standards |
Assay (Dry Basis) |
98.5%–101.5% |
|
pH Value (5% Aqueous Solution) |
2.7–3.3 |
|
|
Loss on Drying |
≤ 5.0% |
|
|
Sulfated Ash |
≤ 0.1% |
|
|
Purity & Impurities |
Solution Clarity |
Clear and colorless (A400 ≤ 0.025) |
|
Nitrates |
Complies with pharmacopeial requirements |
|
|
Sulfates |
≤ 0.03% |
|
|
Individual Impurity |
≤ 0.5% |
|
|
Total Impurities |
≤ 1.0% |
|
|
Heavy Metals |
Lead (Pb) |
≤ 2 ppm |
|
Arsenic (As) |
≤ 1 ppm |
|
|
Total Heavy Metals |
≤ 10 ppm |
|
|
Safety & Logistics |
GHS Classification |
H319 |
|
HS Code |
2936220000 |
|
|
Packaging & Storage |
25 kg/drum; Store in a tightly closed, light-resistant container below 30°C in a cool, dry environment |
Regulatory Certifications & Audit Support
Certified to FSSC 22000 and manufactured according to USP/EP quality requirements.
Batches are available with Kosher and Halal certification documents.
Manufactured under cGMP conditions for pharmaceutical and supplement applications.
DMF and CEP documentation for Thiamine Hydrochloride are available upon request.
Manufacturing Capabilities & QA/QC
Thiamine Synthesis: Multi-ton synthesis lines dedicated to Thiamine Hydrochloride crystallization.
Chloride Salt Controls: Crystallization systems control chloride ion content and acidic pH parameters.
Hygroscopicity Mitigation: Specialized moisture-controlled packaging rooms prevent Thiamine Hydrochloride from absorbing ambient water vapor.
Thiamine Purity Testing: Routine HPLC monitors related substances and pyrimidine-ring impurities.
Mesh Size Customization: Milling infrastructure provides customized particle sizes for tableting applications.
Packaging, Storage & Logistics Options
|
Logistics Aspect |
Technical Options & Specifications for Thiamine Hydrochloride |
|
Primary Containment |
High-strength fiber drums with double-layer polyethylene liners for bulk shipments. |
|
Moisture Barrier |
Optional aluminum foil barrier liners reduce moisture exposure during ocean freight. |
|
Light Protection |
Opaque packaging reduces light exposure during storage and distribution. |
|
Warehouse Controls |
Temperature and humidity levels are routinely monitored during storage. |
|
Handling Protocols |
Standard closed powder-handling systems are used for material transfer. |
|
Transit Management |
Packaging configurations are available for sea freight, air freight, and multimodal transport. |
FAQ
Q: Does Thiamine Hydrochloride exhibit any specific incompatibility with common formulation excipients?
A: It may be incompatible with carbonates, bicarbonates, and citrates due to neutralization reactions.
Q: What cross-contamination protocols protect the Thiamine Hydrochloride line from other B-complex vitamins?
A: The facility utilizes dedicated, isolated air-handling systems and separate production tracks for each distinct vitamin line.
Q: How is the physical integrity of the fiber drums verified before overseas dispatch?
A: Every batch undergoes standard vertical drop and stack-pressure tests to prevent transit leakage.
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