Description

Biotin Impurity 44 is a specified impurity of Biotin (Vitamin B7) used as a critical reference standard in pharmaceutical development and quality control. This compound is essential for ensuring the purity, safety, and efficacy of biotin-containing drug substances and finished products. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and regulatory compliance for biotin APIs and formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Biotin Impurity 44 in Biotin (Vitamin B7) active pharmaceutical ingredients (APIs).
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component in developing and validating chromatographic methods for impurity profiling of biotin.
• Quality Control & Batch Release Testing: Employed in routine QC testing of biotin raw materials and finished drug products to monitor impurity levels against ICH guidelines.
• Stability Studies & Forced Degradation: Used to identify and track this specific degradation product in biotin stability samples under various stress conditions (heat, light, humidity).
• Regulatory Documentation & Submission: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and control strategies for biotin-based medicines.
• Research on Biotin Metabolism & Analogues: Acts as a chemical tool in biochemical research to study biotin pathways, interactions, and the synthesis of novel analogues.

Basic Information

Product Name	Biotin Impurity 44
CAS No.	236117-75-2
Molecular Formula	C10H16N2O3S
Molecular Weight	244.31 g/mol
Synonyms	Biotin Related Compound C; Biotin EP Impurity C; 5-[(3aS,4S,6aR)-2-Oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl]pentanoic acid impurity; Hexahydro-2-oxo-1H-thieno[3,4-d]imidazole-4-pentanoic acid impurity; Vitamin B7 Impurity 44; Biotin Degradation Product; Biotin Process Impurity; D-Biotin Impurity C
EINECS	Contact for details

Quality Control

Our Biotin Impurity 44 is manufactured and controlled under a strict quality management system. Each batch is subjected to comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and specific impurity profiling, to ensure it meets the high standards required for use as a reference material. Certificates of Analysis (COA) with detailed chromatographic data are provided for every batch, supporting compliance with ICH Q3A(R2), Q3B(R2), and pharmacopeial guidelines (USP, EP).

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 material 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 solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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