Description

Biotin Impurity 73 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 known impurity marker. It is primarily required by analytical laboratories, pharmaceutical R&D departments, and quality control units involved in method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of impurities in biotin active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor biotin purity and stability.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and a calibrant in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial standards (USP, EP).
• Stability Studies: Employed in forced degradation studies to understand the degradation pathways of biotin and to establish shelf-life specifications.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the fate of biotin-related compounds in biological systems.

Basic Information

Product Name	Biotin Impurity 73
CAS No.	4375-00-2
Molecular Formula	C10H16N2O3S
Molecular Weight	244.31 g/mol
Synonyms	Biotin Related Compound; Biotin Degradant; Hexahydro-2-oxo-1H-thieno[3,4-d]imidazole-4-pentanoic acid (related isomer); Vitamin B7 Impurity; Biotin Sulfoxide (potential derivative); D-Biotin Impurity; Biotin Analog; Biotin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Biotin Impurity 73 is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS). A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and confirming compliance with in-house specifications tailored for reference standard use.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept in a desiccated environment to prevent moisture absorption, which could affect stability and purity. 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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