Description

Thioridazine Ep Impurity D is a high-purity 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 availability of this well-characterized impurity is essential for maintaining stringent pharmacopeial standards in drug development and manufacturing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Thioridazine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and GC methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed as a system suitability standard in routine batch release testing to ensure product consistency and compliance with EP, USP, or ICH guidelines.
• Stability Studies: Acts as a marker to monitor degradation pathways and establish the shelf-life of Thioridazine-based drug products.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Utilized in metabolic studies, pharmacokinetic research, and the synthesis of related compounds for investigative purposes.

Basic Information

Item	Detail
Product Name	Thioridazine Ep Impurity D
CAS No.	53926-89-9
Molecular Formula	C21H26N2S2
Molecular Weight	370.57 g/mol
Synonyms	10H-Phenothiazine-2-sulfonamide, N,N-dimethyl-10-[2-(1-methyl-2-piperidinyl)ethyl]-; Thioridazine Sulfone; Thioridazine EP Impurity D; Thioridazine Sulfone Impurity; Thioridazine Metabolite Sulfone; Mesoridazine Sulfone; 53926-89-9; Thioridazine Sulfoxide Related Compound D
EINECS	Contact for details

Quality Control

Every batch of Thioridazine Ep Impurity D is manufactured and controlled to meet the highest standards for pharmaceutical reference materials. Our quality system ensures identity, purity, and strength are rigorously verified using advanced analytical techniques including HPLC, GC-MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial monographs (EP/ USP) and ICH Q3A/B guidelines.

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 at -20°C to maximize stability.

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)	≤ 0.5% w/w
Heavy Metals	≤ 20 ppm

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