Description

Tinidazole Impurity 14 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Tinidazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control (QC) and release testing of Tinidazole API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to accurately identify and quantify this specific impurity.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, DMF) by providing definitive impurity characterization data for health authorities like the US FDA and EMA.
• Stability Studies: Employed in forced degradation and long-term stability studies of Tinidazole to monitor impurity formation over time and under various stress conditions.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and process development for Tinidazole.

Basic Information

Item	Detail
Product Name	Tinidazole Impurity 14 Hcl
CAS No.	215034-20-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tinidazole Related Compound 14 Hydrochloride; Tinidazole Impurity 14 Hydrochloride Salt; 1-[2-(Ethylsulfonyl)ethyl]-2-methyl-5-nitro-1H-imidazole Impurity 14 HCl; Tinidazole EP Impurity H HCl; Tinidazole USP Impurity 14 HCl; Tinidazole Process Impurity 14 HCl
EINECS	Contact for details

Quality Control

Every batch of Tinidazole Impurity 14 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced chromatographic and spectroscopic methods.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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