Description

Tinidazole Impurity 11 is a high-purity chemical reference standard used in pharmaceutical research, development, and quality control. This compound is critical for the accurate identification, quantification, and monitoring of process-related impurities during the manufacture of the active pharmaceutical ingredient (API) Tinidazole. It is an essential material for analytical laboratories, quality assurance departments, and R&D facilities within the pharmaceutical and fine chemical industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Tinidazole API and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity analysis.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to ensure Tinidazole batches meet stringent pharmacopeial (USP, EP) and internal purity specifications.
• Stability Studies: Acts as a marker to track impurity formation and degradation pathways in Tinidazole formulations under various storage conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, DMF) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research on Synthesis Pathways: Used by chemists to study and optimize Tinidazole synthesis, helping to minimize the formation of this specific impurity.

Basic Information

Product Name	Tinidazole Impurity 11
CAS No.	140165-54-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-[2-(Ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole; Tinidazole Related Compound; Tinidazole EP Impurity B; Tinidazole USP Impurity; 2-Methyl-1-[2-(ethylsulfonyl)ethyl]-5-nitro-1H-imidazole
EINECS	Contact for details

Quality Control

Every batch of Tinidazole Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure they meet the exacting standards required for pharmaceutical 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 (typically 15-25°C). Keep the container tightly sealed in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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