Description

Thiamine Impurity 20 is a high-purity chemical reference standard, specifically identified as an impurity or degradation product of Thiamine (Vitamin B1). This compound is critical for pharmaceutical research and development, enabling precise analytical method development, stability studies, and quality control of Thiamine-based drug substances and products. It is primarily utilized by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical, nutraceutical, and fine chemical industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of Thiamine Impurity 20 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for Thiamine and related compounds.
• Stability Indicating Studies: Employed in forced degradation and shelf-life studies to monitor the formation of this specific impurity under various stress conditions.
• Quality Control and Batch Release: Essential for in-house QC laboratories to confirm the impurity profile of Thiamine batches meets pharmacopeial (USP, EP) or internal specifications.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways of Thiamine.

Basic Information

Product Name	Thiamine Impurity 20
CAS No.	24941-82-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Thiamine Related Compound 20; Vitamin B1 Impurity 20; 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 systematic name); Thiamine Analog; B1 Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Thiamine Impurity 20 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory needs.

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 must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report and comply with COA
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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