Description

Vitamin B6 Impurity 38 (Trihydrochloride) is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for quality control and method development in pharmaceutical analysis, ensuring the safety and efficacy of Vitamin B6 (Pyridoxine) formulations. It is primarily utilized by research scientists and quality assurance professionals in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material (CRM) for the identification and quantification of process-related impurities in Vitamin B6 active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, validate, and verify HPLC, UPLC, and LC-MS methods for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Stability Studies: Employed in routine QC testing and forced degradation studies to monitor impurity levels and ensure product stability and shelf-life.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization data.
• Academic and Industrial Research: Used in metabolic pathway studies and research on Vitamin B6 chemistry and related compound synthesis.

Basic Information

Product Name	Vitamin B6 Impurity 38 (Trihydrochloride)
CAS No.	78761-51-0
Molecular Formula	C₈H₁₅Cl₃N₂O₂
Molecular Weight	277.57 g/mol
Synonyms	Pyridoxine Impurity 38; 5-(Hydroxymethyl)-2-methylpyridin-3,4-diol trihydrochloride; Vitamin B6 Related Compound 38; 3,4-Dihydroxy-5-(hydroxymethyl)-2-methylpyridine trihydrochloride; Pyridoxine Trihydrochloride Impurity; 78761-51-0; B6 Impurity 38
EINECS	Contact for details

Quality Control

Every batch of Vitamin B6 Impurity 38 (Trihydrochloride) is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for reference materials. Certificates of Analysis (COA) with detailed chromatographic purity, batch-specific data, and traceability are provided.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound 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)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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