Description

Tinidazole Impurity 16 is a designated impurity 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 reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and compliance 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 & Validation: Used as a critical component in developing, optimizing, and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., ICH Q3A/B, USP, EP).
• Stability Studies: Acts as a marker compound to track degradation pathways and assess the shelf-life stability of Tinidazole formulations.
• Regulatory Submissions: Essential for preparing impurity identification and qualification reports required for drug master files (DMFs), ANDAs, and other regulatory filings.
• Research & Development: Utilized in synthetic chemistry research to study the formation and fate of this specific impurity during the manufacturing process.

Basic Information

Product Name	Tinidazole Impurity 16
CAS No.	159790-76-8
Molecular Formula	C8H11N3O3S
Molecular Weight	229.26 g/mol
Synonyms	1-Methyl-5-nitro-1H-imidazole-2-methanol; 2-(Hydroxymethyl)-1-methyl-5-nitroimidazole; 1-Methyl-2-(hydroxymethyl)-5-nitroimidazole; Tinidazole EP Impurity G; Tinidazole Related Compound G; Tinidazole Impurity G; 1-Methyl-5-nitroimidazole-2-methanol
EINECS	Contact for details

Quality Control

Every batch of Tinidazole Impurity 16 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for use as a pharmaceutical reference material. 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 a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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