Description

Thioridazine Ep Impurity A 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 antipsychotic drug Thioridazine and its related pharmaceutical products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The product is supplied with comprehensive documentation to support your research and compliance needs.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Thioridazine Ep Impurity A in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish retention times, calibration curves, and detection limits for this specific impurity.
• Quality Control & Assurance: Essential for routine batch testing of Thioridazine to monitor impurity profiles and ensure they remain within ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products in Thioridazine formulations under various stress conditions.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing a characterized impurity for identification and toxicological assessment.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Thioridazine.

Basic Information

Product Name	Thioridazine Ep Impurity A
CAS No.	100574-22-9
Molecular Formula	C21H26N2S2
Molecular Weight	370.57 g/mol
Synonyms	10H-Phenothiazine-2-sulfonamide, 10-[2-(1-methyl-2-piperidinyl)ethyl]-; Thioridazine EP Impurity A; Thioridazine Related Compound A; Thioridazine Sulfone; 2-Methylmercapto-10-[2-(N-methyl-2-piperidyl)ethyl]phenothiazine Sulfone; Thioridazine Sulfoxide Impurity; Thioridazine Metabolite
EINECS	Contact for details

Quality Control

Every batch of Thioridazine Ep Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards (EP, USP) and ICH guidelines. 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. The product is light-sensitive (store away from light).

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 individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%
Heavy Metals	≤ 20 ppm

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