Description

Tizanidine Related Compound B (50 Mg) (n-Acetyltizanidine) is a high-purity chemical reference standard, specifically identified as a key impurity and degradation product of the muscle relaxant Tizanidine. This compound is essential for pharmaceutical research and development, enabling accurate method development, validation, and quality control testing. It is primarily used by analytical chemists and quality assurance professionals in pharmaceutical manufacturing, contract research organizations (CROs), and regulatory testing laboratories to ensure drug purity and safety.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify n-Acetyltizanidine in Tizanidine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods for stability-indicating assays and related substance tests.
• Stability and Forced Degradation Studies: Employed to monitor the formation of this specific degradant under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure Tizanidine batches meet stringent pharmacopeial (USP, EP) specifications for impurity limits.
• Regulatory Submissions and Compliance: Provides documented evidence of impurity characterization for regulatory filings (e.g., ANDA, NDA) with agencies like the FDA and EMA.
• Research on Drug Metabolism and Degradation Pathways: Aids in studying the metabolic and chemical degradation pathways of Tizanidine.

Basic Information

Product Name	Tizanidine Related Compound B (50 Mg) (n-Acetyltizanidine)
CAS No.	173532-15-5
Molecular Formula	C₁₁H₁₃ClN₄OS
Molecular Weight	284.76 g/mol
Synonyms	n-Acetyltizanidine; 5-Chloro-N-(4,5-dihydro-1H-imidazol-2-yl)-4-(2-oxo-1,3-oxazolidin-3-yl)-2,1,3-benzothiadiazole-7-acetamide; Tizanidine EP Impurity B; Tizanidine USP Related Compound B; Tizanidine Impurity B; 3-Acetyl-5-chloro-N-(4,5-dihydro-1H-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine 1-oxide; Tizanidine Degradant; Tizanidine Metabolite Reference Standard
EINECS	Contact for details

Quality Control

Every batch of Tizanidine Related Compound B is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and mass spectrometry to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each unit, supporting traceability and compliance with cGMP and relevant pharmacopeial guidelines.

Storage

Preserve in the originally supplied, tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive); prolonged exposure to light, moisture, or extreme temperatures should be avoided to maintain stability and purity.

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)	Individual unknown 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.