Description

Thiamine Impurity 18 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 for method development, validation, and impurity profiling in accordance with ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Thiamine Impurity 18 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities in thiamine-based formulations.
• Quality Control & Assurance: Serves as a critical tool in QC labs to ensure batch-to-batch consistency and compliance with pharmacopeial monographs (USP, EP, JP).
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity formation in thiamine under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways and metabolism of thiamine.

Basic Information

Product Name	Thiamine Impurity 18
CAS No.	105070-51-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Thiamine Related Compound; Vitamin B1 Impurity 18; Thiamine Degradation Product; Thiamine Process Impurity; 2-[3-[(4-Amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazol-3-ium-5-yl]ethanol (common structural description); Thiamine Analog; B1 Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Thiamine Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced chromatographic and spectroscopic techniques to ensure they meet the exacting standards required for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and identification.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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