Description

Pyridoxine Impurity 13 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 studies.

Application

• Pharmaceutical Impurity Profiling: Serves 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: Used as a critical standard to develop, calibrate, and validate High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for quality control.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity control and adherence to ICH Q3A/B guidelines.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Vitamin B6 formulations to monitor impurity formation over time.
• Research & Development: Used in chemical research to study the degradation pathways, synthesis by-products, and metabolism of Pyridoxine.
• Quality Control Laboratory: Acts as a system suitability standard and a comparator for routine batch release testing of active pharmaceutical ingredients (APIs).

Basic Information

Product Name	Pyridoxine Impurity 13
CAS No.	1385767-85-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vitamin B6 Impurity 13; Pyridoxine Related Compound 13; Pyridoxine Hydrochloride Impurity 13; 1385767-85-0; (As per specific IUPAC name) Contact for details; Pyridoxine EP Impurity 13; Pyridoxine USP Impurity 13
EINECS	Contact for details

Quality Control

Every batch of Pyridoxine Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment to support your quality and regulatory needs.

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. Keep the container in a dry, cool, and well-ventilated place. Handle and store in accordance with good laboratory practices.

Specification

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

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