Description

Thiamine Impurity 2 is a high-purity chemical reference standard, specifically identified as a key impurity and degradation product of Thiamine (Vitamin B1). This compound is critical for pharmaceutical research and development, enabling precise analytical method development and quality control of thiamine-based products. It is primarily used by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical, nutraceutical, and fine chemical industries to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of Thiamine-related impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, and other chromatographic methods for thiamine analysis.
• Quality Control & Assurance (QC/QA): Essential for establishing specification limits and conducting routine quality control testing in GMP-compliant manufacturing environments.
• Stability Studies: Employed to monitor the formation of degradation products in thiamine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways of Vitamin B1.

Basic Information

Item	Detail
Product Name	Thiamine Impurity 2
CAS No.	7771-57-5
Molecular Formula	C₁₂H₁₆N₄OS
Molecular Weight	264.35 g/mol
Synonyms	Thiamine Disulfide; Thiamine Disulfide Impurity; Thiochrome; Thiochrome (Thiamine Oxidation Product); 3-[(4-Amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methylthiazolium Chloride Disulfide; Vitamin B1 Disulfide; Thiamine Oxidized Form
EINECS	Contact for details

Quality Control

Our Thiamine Impurity 2 is manufactured under strict quality-controlled conditions. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods for structural verification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and chromatographic data is provided with every shipment to support your regulatory and quality 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); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	Yellow to brownish-yellow powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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