Description

Pyridoxine Impurity 12 is a high-purity chemical 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 pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling.

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 and products.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate HPLC, UPLC, and GC analytical methods for quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies of Vitamin B6 formulations to monitor impurity formation.
• Research & Development: Used in academic and industrial R&D settings to study the degradation pathways and metabolism of Pyridoxine.
• Quality Control Testing: Acts as a system suitability standard and a comparator in the routine QC testing of active pharmaceutical ingredients (APIs) and finished drug products.

Basic Information

Item	Details
Product Name	Pyridoxine Impurity 12
CAS No.	58947-70-9
Molecular Formula	C8H11NO3
Molecular Weight	169.18 g/mol
Synonyms	4-Pyridoxic acid lactone; 5-Hydroxy-6-methylpyridine-3,4-dicarboxylic acid 4-lactone; Pyridoxine lactone; Vitamin B6 lactone; 3-Hydroxy-2-methyl-5-[(phosphonooxy)methyl]pyridin-4(1H)-one impurity; Pyridoxine related compound; 5-Hydroxy-6-methyl-3,4-pyridinedicarboxylic acid 4-lactone; Pyridoxine degradation product
EINECS	Contact for details

Quality Control

Every batch of Pyridoxine Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity 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 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 structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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