Description

Pyridoxine Impurity 31 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Pyridoxine (Vitamin B6). It is primarily required by analytical laboratories, quality control units, and research scientists in the pharmaceutical and biotechnology industries for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Pyridoxine hydrochloride and related drug substances and products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, and GC methods in quality control laboratories.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of degradation products in Vitamin B6 formulations.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Chemical Research & Synthesis: Used as an intermediate or a building block in organic synthesis and chemical research focused on pyridine derivatives and vitamin analogs.
• Quality Assurance/Quality Control (QA/QC): Provides a benchmark for in-house quality testing, ensuring batch-to-batch consistency and purity of active pharmaceutical ingredients (APIs).

Basic Information

Product Name	Pyridoxine Impurity 31
CAS No.	18436-47-0
Molecular Formula	C8H11NO3
Molecular Weight	169.18 g/mol
Synonyms	Pyridoxine Related Compound; Vitamin B6 Impurity; 5-(Hydroxymethyl)-2-methylpyridin-3-ol; 3-Hydroxy-5-(hydroxymethyl)-2-methylpyridine; Pyridoxol Impurity; Pyridoxine Degradation Product; 18436-47-0; Pyridoxine Analog
EINECS	Contact for details

Quality Control

Every batch of Pyridoxine Impurity 31 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay and spectroscopic identification, to ensure they meet the high standards required for reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each 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 a controlled room temperature (15-25°C). The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	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.