Description

Thiamine Ep Impurity F Hcl is a high-purity chemical reference standard, specifically identified as an impurity of Thiamine Hydrochloride (Vitamin B1). This compound is critical for analytical method development and validation in pharmaceutical quality control, ensuring the safety and efficacy of final drug products. It is primarily used by research institutions, quality assurance laboratories, and manufacturers in the pharmaceutical and nutraceutical industries for compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the analysis of Thiamine Hydrochloride (Vitamin B1) in accordance with EP (European Pharmacopoeia) and USP (United States Pharmacopeia) monographs.
• Method Development and Validation: Essential for developing, validating, and verifying HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control (QC) Testing: Serves as a system suitability and identification marker in the routine QC testing of active pharmaceutical ingredients (APIs) and finished dosage forms.
• Stability Studies: Employed to monitor the formation of degradation products in Thiamine HCl under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and marketing authorization applications.
• Research and Development: Used in R&D laboratories for studying the degradation pathways and chemical behavior of Thiamine and related compounds.

Basic Information

Product Name	Thiamine Ep Impurity F Hcl
CAS No.	4102-72-1
Molecular Formula	C12H16N4OS • HCl
Molecular Weight	300.80 g/mol (Free base: 264.35 g/mol)
Synonyms	Thiamine Impurity F; Thiamine Hydrochloride Impurity F; Vitamin B1 Impurity F; 2-[3-[(4-Amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazol-3-ium-5-yl]ethanol chloride; Thiamine Related Compound F; EP Impurity F of Thiamine HCl; Thiamine Chloride Impurity F
EINECS	Contact for details

Quality Control

Every batch of Thiamine Ep Impurity F Hcl is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, NMR), to ensure compliance with pharmacopeial standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.