Description

Tizanidine Related Compound C (50 Mg) (1-Acetylimidazolidine-2-Thione) is a high-purity reference standard and key chemical intermediate used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Tizanidine, a muscle relaxant, through rigorous analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for use in method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in Tizanidine HCl active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods in quality control (QC) laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity data required by ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation in drug products.
• Process Chemistry Research: Serves as a marker or intermediate in the research and optimization of Tizanidine synthesis pathways.
• Pharmacopoeial Testing: Used for compliance testing against monographs in pharmacopoeias such as USP, EP, or BP.

Basic Information

Product Name	Tizanidine Related Compound C (50 Mg) (1-Acetylimidazolidine-2-Thione)
CAS No.	5391-52-6
Molecular Formula	C5H8N2OS
Molecular Weight	144.19 g/mol
Synonyms	1-Acetyl-2-thioimidazolidine; 1-Acetyl-2-imidazolidinethione; 1-Acetylimidazolidine-2-thione; Tizanidine Impurity C; Tizanidine Related Substance C; Tizanidine EP Impurity C; Tizanidine Hydrochloride Related Compound C; 2-Imidazolidinethione, 1-acetyl-
EINECS	Contact for details

Quality Control

Every batch of Tizanidine Related Compound C is manufactured and tested under strict quality management systems. The product undergoes comprehensive analytical characterization, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (CoA) detailing all test results and traceability is provided with each shipment.

Storage

Preserve in the originally supplied, 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 should be handled in a dry environment 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)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
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.