Description

Tinidazole Related Compound B (20 Mg) (1-(2-Ethyl-Sulfonylethyl)-2-Methyl-4-Nitroimidazole) is a high-purity reference standard and impurity used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Tinidazole. It is primarily required by analytical laboratories and pharmaceutical manufacturers for method validation, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Tinidazole in drug substances and finished products.
• Impurity Profiling & Control: Essential for identifying, quantifying, and monitoring this specific related substance during API manufacturing and stability testing as per ICH guidelines.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for purity and assay testing.
• Pharmacopeial Compliance: Supports testing to meet the specifications of USP (United States Pharmacopeia), EP (European Pharmacopoeia), and other international regulatory standards.
• Stability-Indicating Studies: Employed in forced degradation studies to understand the degradation pathways of Tinidazole and ensure method specificity.
• Quality Control & Assurance: Used in-house by QC laboratories to calibrate instruments and ensure the accuracy of routine testing for batch release.

Basic Information

Product Name	Tinidazole Related Compound B (20 Mg) (1-(2-Ethyl-Sulfonylethyl)-2-Methyl-4-Nitroimidazole)
CAS No.	25459-12-5
Molecular Formula	C9H15N3O4S
Molecular Weight	261.30 g/mol
Synonyms	1-(2-Ethylsulfonylethyl)-2-methyl-5-nitroimidazole; 1-(2-(Ethylsulfonyl)ethyl)-2-methyl-5-nitro-1H-imidazole; Tinidazole Impurity B; Tinidazole Related Substance B; Tinidazole EP Impurity B; 1H-Imidazole, 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitro-; UNII-3F3T8V2W1M
EINECS	Contact for details

Quality Control

Every batch of Tinidazole Related Compound B is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results for appearance, identification (HPLC/IR), assay (HPLC), and related substances. We support compliance with USP, EP, and ICH guidelines for impurities in new drug substances.

Storage

Preserve in the original tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified 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.