Description

Thiamine Impurity 4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing thiamine (Vitamin B1). It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and quality control departments for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material for the identification and quantification of a specific impurity in Thiamine (Vitamin B1) drug substances and finished products.
• Analytical Method Development and Validation: Used as a critical component in developing and validating HPLC, UPLC, or other chromatographic methods for thiamine analysis.
• Quality Assurance & Regulatory Compliance: Essential for meeting stringent pharmacopoeial standards (USP, EP, JP) and regulatory requirements (FDA, ICH Q3A/B) for drug impurity reporting.
• Stability Studies: Employed in forced degradation and long-term stability studies of thiamine formulations to monitor impurity formation over time.
• Research and Development: Used in academic and industrial R&D to study the degradation pathways, metabolism, and chemical behavior of thiamine.
• Calibration Standard: Acts as a precise calibration standard for analytical instrumentation to ensure accurate and reproducible results.

Basic Information

Product Name	Thiamine Impurity 4
CAS No.	10593-44-9
Molecular Formula	C12H16N4OS
Molecular Weight	264.35 g/mol
Synonyms	Thiamine Related Compound A; Thiamine Hydrochloride Impurity A; 2-[3-[(4-Amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazol-3-ium-5-yl]ethanol; Vitamin B1 Impurity A; Thiamine Chloride Impurity 4; Thiamine Disulfide Impurity; 5-(2-Hydroxyethyl)-3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-4-methylthiazolium
EINECS	Contact for details

Quality Control

Every batch of Thiamine Impurity 4 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure identity, purity, and consistency, supporting compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing purity by HPLC, identification data (IR, NMR), and related substance analysis are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maximize stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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