Description

Perindopril Impurity 16 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Perindopril during development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and quality control laboratories involved in the production and regulatory compliance of cardiovascular medications.

Application

• Pharmaceutical Impurity Profiling and Identification in Perindopril API and finished dosage forms.
• Analytical Method Development and Validation (HPLC, LC-MS) for stability-indicating assays.
• Quality Control and Batch Release Testing to monitor and control impurity levels against ICH guidelines.
• Stability Studies to track the formation of this impurity under various stress conditions.
• Regulatory Submissions as a characterized impurity reference standard for FDA, EMA, and other global health authority filings.
• Research and Development of Perindopril synthesis pathways and degradation chemistry.
• Calibration Standard for quantitative analysis in compliance testing laboratories.

Basic Information

Product Name	Perindopril Impurity 16
CAS No.	169061-41-0
Molecular Formula	C19H32N2O5•C4H4O4
Molecular Weight	484.55 g/mol
Synonyms	Perindopril EP Impurity F; Perindopril Related Compound F; (2S,3aS,7aS)-1-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)butyl]amino]propanoyl]-2,3,3a,4,5,6,7,7a-octahydroindole-2-carboxylic acid fumarate salt; Perindopril Fumarate Impurity; Perindopril Process Impurity; ACE Inhibitor Impurity; 169061-41-0.
EINECS	Contact for details

Quality Control

Our Perindopril Impurity 16 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analyses. We support compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and light-sensitive; ensure containers are sealed immediately after use to prevent degradation from moisture and light exposure.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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