Description

Tizanidine Impurity 1 is a high-purity chemical reference standard, specifically identified as a key impurity in the synthesis and quality control of the active pharmaceutical ingredient Tizanidine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily used in research and development, method validation, and routine quality testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Tizanidine HCl active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure analytical procedures are performing as intended for impurity detection.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing programs.
• Process Chemistry Research: Used by chemists to study and optimize synthetic pathways to minimize the formation of this impurity, thereby improving the overall yield and purity of Tizanidine.

Basic Information

Product Name	Tizanidine Impurity 1
CAS No.	51322-69-1
Molecular Formula	C₉H₈ClN₅S
Molecular Weight	253.71 g/mol
Synonyms	5-Chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole; Tizanidine Related Compound A; Tizanidine EP Impurity A; Tizanidine USP Impurity; 2-Amino-6-chloro-4-(4,5-dihydro-1H-imidazol-2-yl)amino-2,1,3-benzothiadiazole; Benzothiadiazole derivative of Tizanidine; Tizanidine Degradant
EINECS	Contact for details

Quality Control

Every batch of Tizanidine Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC/UPLC) and spectroscopic (MS, NMR) techniques to ensure compliance with pharmacopeial standards (USP, EP). 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 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 reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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