Description

Thiamine Impurity 28 is a high-purity chemical reference standard, specifically identified as an impurity of Thiamine (Vitamin B1). This compound is critical for analytical method development and validation in pharmaceutical quality control, ensuring the safety and efficacy of thiamine-containing products. It is primarily used by research institutions, analytical laboratories, and pharmaceutical manufacturers engaged in drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Thiamine Impurity 28 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits for impurity profiling.
• Quality Control & Assurance: Essential for routine batch testing in GMP environments to monitor and control impurity levels, ensuring product meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of degradation products in thiamine formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways of Thiamine.

Basic Information

Product Name	Thiamine Impurity 28
CAS No.	855380-63-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vitamin B1 Impurity 28; Thiamine Related Compound 28; Thiamine Degradation Product; Thiamine Process Impurity; 855380-63-1; Thiamine Specified Impurity 28
EINECS	Contact for details

Quality Control

Every batch of Thiamine Impurity 28 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial and internal specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; precautions must be taken to minimize exposure to humidity and light during handling to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

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