Description

Alimemazine Ep Impurity A (Trimeprazine Sulfoxide) L-Tartrate is a high-purity reference standard and pharmaceutical impurity critical for analytical research and development. This compound is essential for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Alimemazine (Trimeprazine). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Standard: Used as a certified reference material (CRM) for the identification and quantification of Trimeprazine Sulfoxide in Alimemazine drug substances and finished products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and GC methods to monitor impurities during drug manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine quality control testing to ensure batch-to-batch consistency and purity.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA) to meet FDA, EMA, and other global regulatory requirements.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Alimemazine.

Basic Information

Product Name	Alimemazine Ep Impurity A (Trimeprazine Sulfoxide) L-Tartrate
CAS No.	10071-07-5
Molecular Formula	C22H30N2O2S • C4H6O6
Molecular Weight	584.66 g/mol
Synonyms	Trimeprazine Sulfoxide L-Tartrate; Alimemazine Sulfoxide Tartrate; Alimemazine EP Impurity A; Trimeprazine S-Oxide Tartrate; 10-[3-(Dimethylamino)-2-methylpropyl]-2-(methylsulfinyl)phenothiazine L-Tartrate; (RS)-Trimeprazine Sulfoxide Tartrate; NSC 113986; SQ 10496 Tartrate
EINECS	Contact for details

Quality Control

Every batch of Alimemazine Ep Impurity A (Trimeprazine Sulfoxide) L-Tartrate is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, NMR, and Mass Spectrometry to ensure compliance with pharmacopeial standards (EP, USP). 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 in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%

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