| CAS Number | 67-03-8 |
|---|---|
| Molecular Formula | C12H17ClN4OS·HCl |
| Molecular Weight | 337.27 |
| Pharmacopoeia | BP/USP/CEP/FCC |
| Packaging | 25 KG/DRUM |
Thiamine (Vitamin B1) was the first B vitamin discovered, identified through the study of beriberi, a devastating disease that plagued rice-dependent populations across Asia for centuries. In 1897, Dutch physician Christiaan Eijkman observed that chickens fed polished rice developed beriberi-like paralysis, while those fed unpolished rice remained healthy — the first experimental evidence of a dietary deficiency disease. In 1912, Polish biochemist Casimir Funk isolated the anti-beriberi factor from rice bran and coined the term "vitamine." The pure crystalline compound was isolated in 1926 by Jansen and Donath, and its structure was determined by Robert R. Williams in 1936, who subsequently led the first commercial synthesis program at Merck.
Thiamine HCl is the hydrochloride salt form of thiamine, delivering the highest water solubility among B1 salts. As thiamine pyrophosphate (TPP), the active coenzyme form, it catalyzes the oxidative decarboxylation of pyruvate to acetyl-CoA — the irreplaceable gateway step connecting glycolysis to the Krebs cycle. Without adequate thiamine, carbohydrate metabolism stalls at pyruvate, and cells cannot generate ATP aerobically. This explains why tissues with high glucose demand — brain, heart, peripheral nerves — are the first to show dysfunction during thiamine deficiency.
The hydrochloride salt is the preferred form for pharmaceutical applications requiring high water solubility: injectable solutions, intravenous formulations, liquid oral supplements, and energy drink fortification. Its solubility in water exceeds 1 g/mL at room temperature, making it ideal for concentrated sterile solutions. For solid oral dosage forms, the HCl salt can be used directly in tablets, capsules, and effervescent formulations, though humidity-sensitive applications benefit from the mononitrate alternative.
As of mid-2026, global thiamine HCl demand is driven by expanding clinical nutrition programs in emerging economies, growing parenteral nutrition use in hospital settings, and sustained energy drink market growth. China dominates global thiamine API production, accounting for approximately 80-85% of worldwide supply, with manufacturing concentrated in Zhejiang, Jiangsu, and Hubei provinces. KingWish supplies CEP-certified thiamine HCl manufactured under ICH Q7 GMP conditions, with full regulatory documentation supporting pharmaceutical formulators in over 100 countries.
| Assay (HPLC) | 99.0-101.0% (anhydrous basis), per BP/USP monograph |
|---|---|
| pH (5% aqueous) | 2.7-3.4, per USP |
| Related Substances | Individual impurity ≤ 0.5%, total impurities ≤ 1.0% (BP) |
| Residual Solvents | Compliant with ICH Q3C / Ph. Eur. 5.4 |
| Heavy Metals | ≤ 10 ppm (BP/USP) |
| GMP Status | Manufactured under ICH Q7 GMP; CEP-certified for injectable use |
Request CoA with HPLC assay (99.0-101.0%), pH (2.7-3.4), related substances profile, and residual solvent statement. For injectable use, confirm CEP validity on the EDQM website and request the manufacturer's GMP certificate. DrugBank reference
pH outside the 2.7-3.4 range, elevated related substances indicating degradation, reluctance to share CoA before order, CEP certificate that cannot be verified on EDQM database, and prices significantly below market range (may indicate non-GMP production or adulteration).
Standard: 25 KG/DRUM with PE liner. Store at room temperature (15-25 degrees C), protected from light. Thiamine HCl is hygroscopic — ensure container seals are intact on receipt. Shelf life typically 36 months when properly stored. Custom packaging available upon request.
China produces ~80-85% of global thiamine API. Supply chain stability depends on environmental compliance enforcement in Zhejiang, Jiangsu, and Hubei provinces — factory closures for inspections periodically tighten supply. CEP certification differentiates pharmaceutical-grade suppliers from commodity producers. The thiamine market typically shows moderate price volatility with periodic spikes during regulatory crackdowns.