Description

Pyridoxine Impurity CAS NO 96181-47-4 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 utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, impurity profiling, and stability studies.

Application

• Pharmaceutical Impurity Profiling: 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 & Validation: Used as a critical standard to develop, validate, and verify HPLC, UPLC, and GC methods for accurate impurity detection.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in GMP environments to monitor impurity levels and ensure product specifications are met.
• Stability Studies: Employed to track the formation of degradation products in Pyridoxine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files and submissions.
• Research & Development: Used in chemical and metabolic pathway studies to understand the degradation mechanisms of Vitamin B6 compounds.

Basic Information

Product Name	Pyridoxine Impurity
CAS No.	96181-47-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pyridoxine Related Compound; Vitamin B6 Impurity; Pyridoxine Degradation Product; 4-Pyridoxic acid lactone derivative (potential); Pyridoxine Process Impurity; 96181-47-4; Pyridoxine Analog
EINECS	Contact for details

Quality Control

Every batch of Pyridoxine Impurity CAS 96181-47-4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC/UPLC) and spectroscopic (MS, NMR) 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). For long-term stability, consider storage at 2-8°C. The material is moisture-sensitive; keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.