Description

Biotin Impurity CAS NO 51591-88-9 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 by serving as a key marker in impurity profiling. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, validation, and regulatory compliance. The availability of this well-characterized impurity supports robust quality control protocols in the production of vitamins and active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor specific impurities in biotin drug substances and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to ensure accurate detection and quantification limits.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to confirm that biotin batches meet stringent pharmacopeial specifications (e.g., USP, EP, JP) for impurity limits.
• Stability Studies: Used to track the formation of degradation products in biotin formulations under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research and Development: Facilitates chemical and metabolic pathway studies related to biotin, aiding in the synthesis of novel analogs or understanding degradation mechanisms.

Basic Information

Product Name	Biotin Impurity
CAS No.	51591-88-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Biotin Related Compound; Biotin Degradation Product; Biotin Process Impurity; Biotin Analog; Hexahydro-2-oxo-1H-thieno[3,4-d]imidazole-4-pentanoic acid derivative; Vitamin B7 Impurity; Biotin Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Biotin Impurity CAS 51591-88-9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity screening using advanced analytical techniques to ensure they meet the exacting standards required for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and identification. We support compliance with cGMP, ICH Q3A/B, and relevant pharmacopeial guidelines.

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); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	Contact for details
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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