Thiamine Hydrochloride API is the hydrochloride salt of thiamine (Vitamin B1) and is an essential vitamin used in pharmaceutical, nutritional and therapeutic formulations. It plays a central role in carbohydrate, amino-acid and fatty-acid metabolism after conversion to its biologically active coenzyme form, thiamine pyrophosphate (TPP). PubChem identifies Thiamine Hydrochloride with CAS 67-03-8, molecular formula C₁₂H₁₈Cl₂N₄OS, and molecular weight 337.3 g/mol.
Thiamine Hydrochloride is a well-established pharmaceutical-grade vitamin B1 substance and is recognized in major pharmacopoeial systems, including the USP, International Pharmacopoeia and other compendial standards. The International Pharmacopoeia 2025 specifies 98.0–101.0% content calculated with reference to the dried substance.
Thiamine Hydrochloride is also known as Thiamine HCl, Vitamin B1 Hydrochloride and Aneurine Hydrochloride. FDA GSRS identifies CAS 67-03-8 and UNII M572600E5P for the substance.
The compound contains a thiazolium ring linked to a substituted pyrimidine ring. As a water-soluble vitamin salt, it is particularly suitable for pharmaceutical formulations where rapid dissolution in aqueous systems is required.
| Property | Value |
|---|---|
| Product Name | Thiamine Hydrochloride |
| Synonyms | Thiamine HCl, Vitamin B1 Hydrochloride, Aneurine Hydrochloride |
| CAS Number | 67-03-8 |
| FDA UNII | M572600E5P |
| Molecular Formula | C₁₂H₁₈Cl₂N₄OS |
| Molecular Weight | 337.27 g/mol |
| Category | Vitamin / Nutritional API |
| Therapeutic Class | Vitamin B1 |
| Appearance | White crystals or crystalline powder |
PubChem reports the molecular weight as 337.3 g/mol and describes the material as white to light-yellow crystalline material; it is freely soluble in water and slightly soluble in alcohol.
Following absorption, thiamine is converted into phosphorylated forms, principally thiamine pyrophosphate (TPP). TPP acts as an essential coenzyme in several enzymatic reactions involved in carbohydrate and energy metabolism.
Thiamine-dependent enzymes participate in oxidative decarboxylation reactions and transketolase pathways. Adequate thiamine is therefore important for normal cellular energy production and neurological function.
Thiamine Hydrochloride API is used in pharmaceutical preparations intended to provide Vitamin B1. Applications include formulations for:
Thiamine deficiency can affect neurological and cardiovascular function, making reliable pharmaceutical-grade thiamine an important component of deficiency-management formulations.
Thiamine Hydrochloride has established pharmacopoeial quality requirements. The International Pharmacopoeia Twelfth Edition (2025) specifies content of 98.0–101.0%, calculated with reference to the dried substance. It also describes the characteristic identification reactions and a melting temperature of approximately 248°C with some decomposition.
Current USP-compliant commercial specifications reported by Avantor include:
These USP-associated commercial values are particularly useful for CMS fields, while the exact acceptance criterion should ultimately follow the intended pharmacopoeial/customer specification.
Thiamine Hydrochloride API is produced under controlled pharmaceutical manufacturing conditions with appropriate controls for raw materials, reaction chemistry, purification, crystallization and drying.
A qualified Thiamine Hydrochloride API Manufacturer in India should maintain validated analytical methods and appropriate controls for assay, water, inorganic residue, solution characteristics and chromatographic purity.
Thiamine Hydrochloride is a white crystalline powder and is freely soluble in water, soluble in glycerin and slightly soluble in alcohol. It is insoluble in ether and benzene.
The substance is hygroscopic in its anhydrous form and can rapidly absorb approximately 4% water when exposed to air. The International Pharmacopoeia reports a melting temperature of approximately 248°C with some decomposition.
Thiamine Hydrochloride should be protected from excessive moisture, light and unsuitable environmental conditions. Because the anhydrous material can absorb water from air, moisture-protective packaging is important.
Bulk API packaging should follow the validated stability program and the applicable pharmacopoeial/customer storage requirements.
A professional Thiamine Hydrochloride API supply package may include:
A reliable Thiamine Hydrochloride API Manufacturer in India should provide pharmaceutical-grade material with consistent assay, controlled moisture, appropriate chromatographic purity and complete batch documentation. Thiamine Hydrochloride is a well-established pharmacopoeial substance with recognized quality requirements across international standards.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.2% |
| pH (1% Solution) | 2.7–3.4 at 25°C |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 5.0% |
| Melting Point | About 248°C, with some decomposition |