Description

Thiamine Impurity 22 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 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 specific impurities in Thiamine (Vitamin B1) Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor and control impurity levels, ensuring batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Thiamine under various environmental conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in metabolic and pharmacokinetic research to study the behavior and impact of this specific impurity.

Basic Information

Item	Detail
Product Name	Thiamine Impurity 22
CAS No.	855380-68-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Thiamine Related Compound 22; Vitamin B1 Impurity 22; Thiamine Degradation Product; Thiamine Process Impurity; 2-[3-[(4-Amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazol-3-ium-5-yl]ethyl acetate (common IUPAC-based name); Thiamine Monophosphate Impurity (potential related compound); B1 Impurity Standard
EINECS	Contact for details

Quality Control

Our Thiamine Impurity 22 is manufactured under strict quality systems to ensure the highest standards of purity and traceability. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques including HPLC, GC, and NMR for identity confirmation and purity assessment. We adhere to relevant guidelines for reference standards to support your pharmaceutical compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0%

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