Description

Mecobalamin Impurity CAS NO 17234-76-3 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 Mecobalamin (Vitamin B12a). It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Mecobalamin Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and release testing to monitor impurity levels and ensure batch-to-batch consistency according to pharmacopeial standards (e.g., USP, EP, JP).
• Stability Studies: Employed to track the formation of degradation products in Mecobalamin formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data required by agencies like the FDA and EMA.
• Research & Development: Used in academic and industrial R&D to study the metabolism, degradation pathways, and chemical behavior of Mecobalamin analogs.

Basic Information

Product Name	Mecobalamin Impurity
CAS No.	17234-76-3
Molecular Formula	C63H91CoN13O14P
Molecular Weight	1349.4 g/mol
Synonyms	Methylcobalamin Impurity; Vitamin B12a Impurity; Coα-[α-(5,6-Dimethylbenzimidazolyl)]-Coβ-methylcobamide Impurity; Mecobalamin Related Compound; Cobamamide Impurity; Methyl B12 Impurity; (SP-4-2)-[(Coα)-[α-(5,6-Dimethyl-1H-benzimidazol-1-yl)]-Coβ-methylcobamide] Impurity
EINECS	Contact for details

Quality Control

Our Mecobalamin Impurity is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data, test methods, and results. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	Red to dark red crystalline powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (UV-Vis)	Spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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