Description

Biotin Impurity CAS NO 863203-60-5 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 required by pharmaceutical R&D laboratories, quality control (QC) departments, and analytical service providers for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in biotin active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure accurate detection and quantification limits.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing to verify that biotin products meet stringent pharmacopeial specifications (e.g., USP, EP, JP) for impurity limits.
• Stability Studies: Used to track the formation and growth of this impurity over time under various stress conditions, supporting shelf-life determination and regulatory filings.
• Regulatory Compliance and Submission: Essential for preparing documentation for regulatory agencies (FDA, EMA, etc.) to demonstrate thorough impurity characterization and control.
• Research and Synthesis: Acts as a building block or intermediate for chemical researchers studying biotin analogs or related metabolic pathways.

Basic Information

Product Name	Biotin Impurity
CAS No.	863203-60-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Biotin Related Compound; Biotin Process Impurity; Hexahydro-2-oxo-1H-thieno[3,4-d]imidazole-4-pentanoic acid derivative (specific isomer); Vitamin B7 Impurity; Biotin Analog; Biotin Degradant; Biotin Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Biotin Impurity CAS 863203-60-5 is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including HPLC purity assay, related substance analysis, and identity confirmation (IR, MS), to ensure it meets the high standards required for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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