Description

Pyridoxine Impurity 5 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the identification, qualification, and control of process-related impurities in the synthesis of Pyridoxine (Vitamin B6) and its derivatives. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical and nutraceutical industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Pyridoxine HCl and related drug substances.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate HPLC, UPLC, and GC analytical methods for quality control laboratories.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation in Vitamin B6 formulations.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings with agencies like the FDA, EMA, and PMDA to support drug approval processes.
• Quality Control & Batch Release: Acts as a system suitability standard in routine QC testing to ensure the consistency and purity of manufactured Pyridoxine batches.
• Research & Development: Used in synthetic chemistry R&D to understand and optimize the Pyridoxine manufacturing process, minimizing impurity formation.

Basic Information

Product Name	Pyridoxine Impurity 5
CAS No.	412940-03-5
Molecular Formula	C8H11NO3
Molecular Weight	169.18 g/mol
Synonyms	Pyridoxine Related Compound; Vitamin B6 Impurity 5; 5-(Hydroxymethyl)-2-methylpyridin-3-ol; 3-Hydroxy-5-(hydroxymethyl)-2-methylpyridine; Pyridoxine Process Impurity; Pyridoxol Impurity; 412940-03-5; B6 Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Pyridoxine Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. 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 must be kept in a desiccated environment 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)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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