Description

Trimetazidine Impurity 10 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 active pharmaceutical ingredient (API) Trimetazidine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Trimetazidine Impurity 10 in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor and control impurity levels in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Trimetazidine API and formulations meet specified purity criteria and pharmacopeial standards (e.g., EP, USP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., DMF, CMC sections) to support drug approval processes with agencies like the FDA and EMA.
• Research & Development: Serves as a key reagent in pharmaceutical R&D for studying the metabolic pathways, degradation mechanisms, and synthesis of Trimetazidine.

Basic Information

Product Name	Trimetazidine Impurity 10
CAS No.	959047-57-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-(2,3,4-Trimethoxybenzyl)piperazine Impurity 10; Trimetazidine Related Compound 10; 959047-57-5; Trimetazidine EP Impurity J; Trimetazidine USP Impurity; Trimetazidine Process Impurity; Trimetazidine Degradant
EINECS	Contact for details

Quality Control

Our Trimetazidine Impurity 10 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data to support your regulatory and quality needs. The material is suitable for use as a pharmaceutical reference standard in compliance with current Good Manufacturing Practice (cGMP) principles.

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 material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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