Description

Biotin Impurity C CAS NO 412308-26-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of biotin (Vitamin B7) and related pharmaceutical products through precise impurity profiling. It is an essential material for analytical chemists, quality control laboratories, and R&D departments within the pharmaceutical and nutraceutical industries.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of Biotin Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Used in the development, calibration, and validation of analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS.
• Quality Control & Assurance (QC/QA): A critical component in routine quality control testing to monitor impurity levels and ensure compliance with pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of biotin to understand degradation pathways.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization.
• Research & Development: Used in synthetic chemistry research to study the metabolism and degradation of biotin.

Basic Information

Product Name	Biotin Impurity C
CAS No.	412308-26-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Biotin Related Compound C; Biotin Degradant C; Biotin EP Impurity C; Biotin USP Impurity C; (3aS,4S,6aR)-Hexahydro-2-oxo-1H-thieno[3,4-d]imidazole-4-pentanoic acid (related to biotin degradation); Vitamin B7 Impurity C
EINECS	Contact for details

Quality Control

Our Biotin Impurity C is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot to support your regulatory and quality requirements.

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. Avoid prolonged exposure to air.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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