Description

Pyridoxine Impurity 9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critically important for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Pyridoxine (Vitamin B6). It is primarily required by analytical laboratories, quality control departments, and research institutions in the global pharmaceutical and biotechnology industries for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Pyridoxine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity detection in compliance with ICH guidelines.
• Quality Control and Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive impurity characterization data for drug master files and investigational new drug applications.
• Stability Studies: Employed in forced degradation and long-term stability studies of Pyridoxine formulations to track impurity formation over time and under various stress conditions.
• Research and Development: Used in academic and industrial R&D to study the degradation pathways, metabolism, and chemical behavior of Pyridoxine and related compounds.

Basic Information

Product Name	Pyridoxine Impurity 9
CAS No.	1385767-86-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vitamin B6 Impurity 9; Pyridoxine Related Compound 9; Pyridoxine EP Impurity G; Pyridoxine USP Related Substance; 4-(Hydroxymethyl)-2-methylpyridin-3-ol (possible core structure); Pyridoxol Impurity; B6 Degradation Product; Pyridoxine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Pyridoxine Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced techniques like HPLC and mass spectrometry to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is typically light-sensitive and may be hygroscopic; therefore, it should be handled in a dry environment and the container kept tightly sealed after each use to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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