Description

Cyanocobalamin Impurity F is a specified impurity of Vitamin B12 (Cyanocobalamin), a critical reference standard in pharmaceutical quality control. This compound is essential for the analytical validation and monitoring of Cyanocobalamin active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cyanocobalamin Impurity F in drug substances and products.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS methods.
• Quality Control (QC) Testing: Employed in routine QC testing of Cyanocobalamin APIs to monitor impurity profiles and ensure batch-to-batch consistency.
• Stability Studies: Used to track the formation of this specific degradation product during forced degradation and long-term stability studies of Vitamin B12 formulations.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
• Research and Development: Facilitates research into the degradation pathways and stability of Cyanocobalamin.

Basic Information

Product Name	Cyanocobalamin Impurity F
CAS No.	23208-66-4
Molecular Formula	C₆₂H₈₈CoN₁₃O₁₄P
Molecular Weight	1357.3 g/mol
Synonyms	Cobinamide dicyanide, Co-α-[α-(5,6-Dimethylbenzimidazolyl)]-Co-β-cyanocobamide; Vitamin B12 Impurity F; Cyanocobalamin Related Compound F; Dicyanocobinamide; Cob(II)alamin; B12 Impurity F; Cobalamin Impurity F
EINECS	Contact for details

Quality Control

Our Cyanocobalamin Impurity F is manufactured and handled under strict quality management systems. Each batch is characterized and tested to ensure high purity and suitability for use as an analytical reference standard. A comprehensive Certificate of Analysis (COA) is provided, detailing results from advanced analytical techniques including HPLC, NMR, and MS for structural confirmation and purity assessment. We support compliance with USP, EP, ICH, and other relevant pharmaceutical guidelines.

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 Certificate of Analysis. The product is light-sensitive and should be stored away from direct light exposure.

Specification

Item	Specification
Appearance	Red to dark red crystalline powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (UV-Vis)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%

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