Description

Biotin Impurity CAS NO 51591-87-8 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 biotin (Vitamin B7) and related pharmaceutical products. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in biotin active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate HPLC, UPLC, and LC-MS methods for purity analysis.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and release testing to ensure biotin batches meet stringent pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to monitor impurity formation and degradation pathways in biotin formulations under various storage conditions.
• Academic & Industrial Research: Used in metabolic studies, synthesis pathway research, and the development of new analytical techniques related to biotin and its derivatives.

Basic Information

Product Name	Biotin Impurity
CAS No.	51591-87-8
Molecular Formula	C10H16N2O3S
Molecular Weight	244.31 g/mol
Synonyms	Biotin Related Compound; Desthiobiotin Sulfoxide; Hexahydro-2-oxo-1H-thieno[3,4-d]imidazole-4-pentanoic acid, 3-oxide; Biotin Sulfoxide; Biotin Impurity C (EP); Biotin Impurity F (USP); Vitamin B7 Impurity; 5-[(3aS,4S,6aR)-2-Oxo-1,3,3a,4,6,6a-hexahydrothieno[3,4-d]imidazol-4-yl]pentanoic acid S-oxide
EINECS	Contact for details

Quality Control

Every batch of our Biotin Impurity is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) that include data from orthogonal analytical techniques such as HPLC, NMR, and MS to confirm identity and purity. Our quality standards are designed to meet the rigorous demands of pharmaceutical reference materials, supporting compliance with ICH guidelines and pharmacopeial monographs.

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 under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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