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Vitamin B1 (Thiamine HCl)

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Vitamin B1 (Thiamine HCl) molecular structure
Quick Facts
CAS Number67-03-8
Molecular FormulaC12H17ClN4OS·HCl
Molecular Weight337.27
PharmacopoeiaBP/USP/CEP/FCC
Packaging25 KG/DRUM
BP Grade USP Grade CEP Certified FCC Grade

Product Overview

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.

Quality Specifications

Assay (HPLC)99.0-101.0% (anhydrous basis), per BP/USP monograph
pH (5% aqueous)2.7-3.4, per USP
Related SubstancesIndividual impurity ≤ 0.5%, total impurities ≤ 1.0% (BP)
Residual SolventsCompliant with ICH Q3C / Ph. Eur. 5.4
Heavy Metals≤ 10 ppm (BP/USP)
GMP StatusManufactured under ICH Q7 GMP; CEP-certified for injectable use

Applications

  • Pharmaceutical Preparations: Tablets, capsules, and oral solid dosage forms of thiamine for therapeutic use
  • Injectable Formulations: Sterile injectable solutions for clinical administration in hospital and clinical settings
  • Dietary Supplements: High-potency B1 and B-complex supplement formulations
  • Energy Drinks: Water-soluble format for fortification of sports and energy beverages
  • Clinical Nutrition: Parenteral and enteral nutrition formulations for patient care

Sourcing Thiamine HCl: Key Checks

Documentation

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

Red Flags

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).

Packaging & Logistics

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.

Market Context

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.

Frequently Asked Questions

Thiamine HCl (hydrochloride salt) is highly water-soluble and best suited for injectable formulations, liquid supplements, and energy drinks. Thiamine mononitrate is non-hygroscopic, more stable in dry formulations, and preferred for food fortification, flour enrichment, and solid dosage supplements. The HCl form delivers approximately 89.2% thiamine base by weight, while the mononitrate delivers about 81.1%. Choose HCl when water solubility and injectable-grade purity drive the application; choose mononitrate for dry blending, extended shelf life, and moisture-sensitive formulations.
Thiamine, as thiamine pyrophosphate (TPP), is the essential coenzyme for pyruvate dehydrogenase — the enzyme that converts pyruvate from glycolysis into acetyl-CoA, which enters the Krebs cycle for aerobic energy production. Without thiamine, carbohydrate metabolism stalls at pyruvate, and cells (especially neurons and cardiac myocytes) become energy-deprived. Deficiency causes beriberi — historically endemic in populations dependent on polished rice — with two forms: dry beriberi (peripheral neuropathy, muscle wasting) and wet beriberi (high-output cardiac failure). Wernicke-Korsakoff syndrome occurs in chronic alcoholism due to thiamine malabsorption. Modern at-risk populations include dialysis patients, bariatric surgery patients, and those on long-term parenteral nutrition without adequate thiamine supplementation.
For pharmaceutical applications (especially injectable formulations), a CEP (Certificate of Suitability) from the EDQM is the most rigorous certification — it confirms compliance with the European Pharmacopoeia monograph and ICH Q7 GMP manufacturing. For the US market, USP grade with an active DMF filing is required. For food and dietary supplement applications, FCC grade confirms food-grade purity. KingWish holds CEP certification for our thiamine HCl, supporting the most demanding injectable and ophthalmic applications. Always verify CEP validity on the EDQM Certification Database before placing an order.
China dominates global thiamine HCl production, accounting for an estimated 80-85% of worldwide API supply, with manufacturing concentrated in Zhejiang, Jiangsu, and Hubei provinces. Key intermediates (carbonitrile, acetylbutyrolactone) are also predominantly Chinese-sourced. India produces finished thiamine formulations but imports the majority of its API from China. Supply chain disruptions — typically triggered by environmental enforcement inspections or factory closures — can cause multi-month price volatility of 20-40%. Standard risk management practice for pharmaceutical formulators is to qualify at least two independent suppliers and maintain buffer inventory of 3-6 months' demand.
Standards: BP/USP/CEP/FCC  |  CAS: 67-03-8  |  Quality data verified against pharmacopoeia monograph COA and MSDS available  |  DrugBank  |  July 2026

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