Description

Trandolapril Related Compound D (25 Mg) ((S)-Ethyl 2-[(3S, 5As, 9Ar, 10As)-3-Methyl-1,4-Dioxodecahydropyrazino[1,2-A]Indol-2(1H)-Yl]-4-Phenylbutanoate) is a high-purity chemical reference standard, specifically identified as a known impurity or degradation product of the active pharmaceutical ingredient Trandolapril. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical formulations by enabling precise analytical control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and quality assurance processes in drug development and production.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material for the identification and quantification of Trandolapril-related impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH guidelines.
• Quality Control and Stability Testing: Essential for routine quality control testing and stability studies to monitor impurity levels and ensure product shelf-life and compliance with pharmacopeial standards (e.g., USP, EP).
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Utilized in pharmaceutical R&D to study degradation pathways, synthesis pathways, and the metabolic fate of Trandolapril.
• Calibration of Laboratory Equipment: Acts as a precise calibration standard for ensuring the accuracy and reliability of analytical instrumentation.

Basic Information

Item	Details
Product Name	Trandolapril Related Compound D (25 Mg) ((S)-Ethyl 2-[(3S, 5As, 9Ar, 10As)-3-Methyl-1,4-Dioxodecahydropyrazino[1,2-A]Indol-2(1H)-Yl]-4-Phenylbutanoate)
CAS No.	149881-40-3
Molecular Formula	C25H34N2O4
Molecular Weight	426.55 g/mol
Synonyms	Trandolapril Impurity D; Trandolapril Related Substance D; (S)-Ethyl 2-[(3S,5aS,9aR,10aS)-3-Methyl-1,4-dioxodecahydropyrazino[1,2-a]indol-2(1H)-yl]-4-phenylbutanoate; Ethyl (2S)-2-[(3S,5aS,9aR,10aS)-3-methyl-1,4-dioxodecahydropyrazino[1,2-a]indol-2-yl]-4-phenylbutanoate; Trandolapril EP Impurity D; Trandolapril USP Related Compound D
EINECS	Contact for details

Quality Control

Our Trandolapril Related Compound D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) containing detailed test results are provided and traceable to primary standards. Our quality commitment aligns with cGMP principles and supports compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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