Description

Tinidazole Impurity 2 is a designated impurity reference standard used in the analytical profiling and quality control of the pharmaceutical active ingredient Tinidazole. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Tinidazole API and finished dosage forms.
• Analytical Method Development: Used in developing and optimizing HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance: Essential for routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial limits (e.g., ICH Q3B).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation and growth of this specific impurity during drug product stability testing under various conditions.
• Research & Development: Used in synthetic chemistry R&D to understand degradation pathways and improve the manufacturing process of Tinidazole.

Basic Information

Product Name	Tinidazole Impurity 2
CAS No.	140165-55-5
Molecular Formula	C8H11N3O3S
Molecular Weight	229.26 g/mol
Synonyms	1-[2-(Ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole; 2-Methyl-1-[2-(ethylsulfonyl)ethyl]-5-nitro-1H-imidazole; Tinidazole EP Impurity B; Tinidazole USP Related Compound B; Tinidazole Impurity B; 1H-Imidazole, 2-methyl-1-[2-(ethylsulfonyl)ethyl]-5-nitro-; Ethylsulfonylethyl Methylnitroimidazole
EINECS	Contact for details

Quality Control

Every batch of Tinidazole Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)

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