Description

Thiamine Impurity 27 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, quality control (QC) laboratories, and research institutions involved in method development, impurity profiling, and stability studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of impurities in Thiamine (Vitamin B1) API and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate HPLC, UPLC, or GC methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial standards (USP, EP, JP).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Thiamine.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in academic and industrial R&D for studying the metabolism, synthesis, and analytical chemistry of thiamine-related compounds.

Basic Information

Product Name	Thiamine Impurity 27
CAS No.	1196-75-4
Molecular Formula	C12H16N4OS
Molecular Weight	264.35 g/mol
Synonyms	Thiamine Related Compound A; Vitamin B1 Impurity 27; 2-[3-[(4-Amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazol-3-ium-5-yl]ethanol; Thiamine Degradation Product; Thiamin Impurity A; 5-(2-Hydroxyethyl)-4-methyl-3-[(2-methyl-4-aminopyrimidin-5-yl)methyl]thiazolium
EINECS	Contact for details

Quality Control

Every batch of Thiamine Impurity 27 is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including confirmation of structure and high purity. A detailed Certificate of Analysis (COA) is supplied with each lot, containing results from HPLC purity assay, identity confirmation (IR, NMR), and related substance analysis. Our quality commitment ensures the material is suitable for its intended use in regulated environments.

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); ensure the container is sealed tightly after each use to prevent exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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