Product Overview
Vitamin B1 is a water-soluble vitamin used as a coenzyme in carbohydrate metabolism and energy-related biochemical processes.
Technical Specifications
|
Parameter Category |
Technical Parameter |
Specification 1 (Food/Feed Grade) |
Specification 2 (Pharma Grade) |
|
Product Information |
Product Name |
Vitamin B1 |
Vitamin B1 |
|
Available Forms |
Thiamine Mononitrate (Nitrate Salt) |
Thiamine Hydrochloride (HCl Salt) |
|
|
Active B1 Content |
~91.8% |
~78.5% |
|
|
Physical Properties |
Appearance |
White to light yellowish crystalline powder |
White or almost white crystalline powder |
|
Solubility (20°C) |
Sparingly soluble in water (~2.7 g/100 mL) |
Freely soluble in water (~1 g/1 mL) |
|
|
Hygroscopicity |
Non-hygroscopic (Stable in air) |
Highly hygroscopic (Absorbs moisture) |
|
|
Melting Point |
~196°C – 200°C (with decomposition) |
~248°C (with decomposition) |
|
|
Bulk Density |
0.35 – 0.55 g/mL |
0.25 – 0.40 g/mL |
|
|
Chemical & Purity |
Assay (Dry Basis) |
98.0% – 102.0% |
98.5% – 101.5% |
|
pH Value |
6.0 – 7.5 (2% aqueous suspension) |
2.7 – 3.4 (2.5% aqueous solution) |
|
|
Loss on Drying |
≤1.0% |
≤5.0% |
|
|
Residue on Ignition |
≤0.2% |
≤0.2% |
|
|
Total Impurities |
≤1.0% |
≤1.0% |
|
|
Heavy Metals |
Lead (Pb) |
≤2 ppm |
≤2 ppm |
|
Arsenic (As) |
≤1 ppm |
≤1 ppm |
|
|
Total Heavy Metals |
≤10 ppm |
≤10 ppm |
|
|
Microbiological |
Total Aerobic Count |
≤1,000 cfu/g |
≤1,000 cfu/g |
|
Yeasts & Moulds |
≤100 cfu/g |
≤100 cfu/g |
|
|
E. coli / Salmonella |
Negative |
Negative |
|
|
Compliance |
Standard |
FCC / USP / Feed Grade |
USP / EP / BP / ChP / GMP |
Production & Quality Control
Salt-Specific Moisture Control
Thiamine Mononitrate moisture is controlled at ≤1.0% according to product specifications.
Precision pH Regulation
Aqueous pH is maintained within 2.7–3.4 for process control purposes.
Thiamine-Specific Purity Assurance
HPLC testing verifies total related substances at ≤1.0% for specification compliance.
Solution Clarity Verification
Absorbance values are maintained at ≤0.025, confirming solution clarity requirements.
Packaging & Logistics
Light-Resistant Packaging
Multi-layer aluminum foil bags provide light protection during storage and transport.
Moisture-Proof Drum Sealing
Sealed high-density drums are used to reduce moisture exposure.
Temperature-Controlled Logistics
Shipping below 25°C is recommended during transportation.
Vacuum-Sealed Inner Liners
Oxygen-barrier liners are used to reduce oxygen exposure during storage.
Regulatory & Documentation
Pharmacopoeia Compliance: Regulatory dossiers are prepared with reference to USP, EP, BP, and ChP thiamine monographs.
Process Impurity Statements: Statements document the control of pyrimidine and thiazole-related process materials.
Salt-Specific BSE/TSE Statements: Official statements verify that crystallization processes for Vitamin B1 utilize non-animal materials.
Residual Solvents Control: GC-MS reports verify that crystallization solvents meet strict ICH limits.
Applications
|
Application Field |
How It Is Used |
|
Pharmaceuticals |
Used in the manufacture of thiamine-containing injections, tablets, capsules, and oral liquid formulations. |
|
Dietary Supplements |
Incorporated into multivitamin products, B-complex supplements, capsules, tablets, and nutritional premixes. |
|
Food & Beverages |
Added to fortified flour, cereals, bakery products, beverages, and functional foods. |
|
Animal Nutrition |
Included in premixes, aquaculture feed, livestock feed, and companion animal nutrition products. |
FAQ
Q: How is temperature controlled during the milling of Vitamin B1?
A: Milling lines utilize air-cooling systems to control processing temperatures.
Q: Can the factory provide batch-specific particle size distributions for Vitamin B1?
A: Yes, laser diffraction grain-size analysis charts are supplied to ensure compatibility with varied customer blending equipment.
Q: How does the factory ensure no cross-contamination between different grades of Vitamin B1?
A: Separate, dedicated synthesis lines and isolated cleanrooms are utilized for pharmaceutical and feed-grade production runs.
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