Description

Tizanidine EP Impurity C is a high-purity reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient Tizanidine by accurately identifying and quantifying related substances. It is primarily required by pharmaceutical manufacturers and analytical laboratories engaged in research, development, and regulatory compliance testing for Tizanidine-based formulations.

Application

• Primary use as a pharmacopoeial reference standard (e.g., EP, USP) for system suitability and method validation.
• Quality control and assurance in the manufacturing of Tizanidine API and finished dosage forms.
• Analytical method development and validation for impurity profiling in compliance with ICH guidelines.
• Use in stability studies to monitor degradation pathways of Tizanidine.
• Calibration of analytical instruments such as HPLC, UPLC, and LC-MS systems.
• Supporting regulatory filings (e.g., ANDA, NDA) by providing definitive impurity identification.
• Academic and industrial research into the metabolism and degradation of Tizanidine.

Basic Information

Product Name	Tizanidine EP Impurity C
CAS No.	1147548-83-1
Molecular Formula	C₉H₈ClN₅S
Molecular Weight	253.71 g/mol
Synonyms	Tizanidine EP Impurity C; Tizanidine Related Compound C; Tizanidine Impurity C; Tizanidine EP Impurity C; 2,1,3-Benzothiadiazol-4-amine, 5-chloro-N-2-imidazolin-2-yl-; UNII-9V6R871N7K; Tizanidine Hydrochloride Impurity C
EINECS	Contact for details

Quality Control

Every batch of Tizanidine EP Impurity C is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) detailing all test results and methods 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). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture uptake.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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