Description

Biotin Impurity CAS NO 171232-73-8 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 marker for impurity profiling. It is an essential tool for professionals in pharmaceutical development, quality control laboratories, and regulatory affairs who require reliable standards for method validation and compliance testing. The availability of this well-characterized impurity supports robust analytical workflows and helps manufacturers meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) for the identification, quantification, and control of related substances in biotin active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to ensure specificity, accuracy, and precision in impurity detection.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to monitor batch-to-batch consistency and ensure compliance with specifications from USP, EP, ICH, and other regulatory guidelines.
• Stability Studies and Forced Degradation Testing: Acts as a key analyte in studies designed to identify and quantify degradation products, helping to establish shelf-life and recommended storage conditions.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies as per ICH Q3A/B guidelines.
• Research and Development (R&D): Utilized in metabolic studies, synthesis pathway research, and the development of new analytical techniques for vitamins and coenzymes.
• Calibration Standard for Instrumentation: Used to calibrate analytical instruments to ensure reliable and reproducible quantitative results in impurity analysis.

Basic Information

Product Name	Biotin Impurity
CAS No.	171232-73-8
Molecular Formula	C10H16N2O3S
Molecular Weight	244.31 g/mol
Synonyms	Biotin Related Compound; Biotin Degradant; Biotin Process Impurity; Hexahydro-2-oxo-1H-thieno[3,4-d]imidazole-4-pentanoic acid derivative; Dethiobiotin sulfoxide analog; Vitamin B7 Impurity; Biotin Sulfoxide; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Biotin Impurity CAS 171232-73-8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with industry standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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