Description

Ramipril Impurity 17 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Ramipril during its development and manufacturing. It is an essential tool for pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify and quantify this specific impurity in Ramipril API 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.
• Stability Studies and Forced Degradation: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure Ramipril batches comply with stringent pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the impurity profile.
• Research and Development: Used in R&D to study the degradation pathways and chemical behavior of Ramipril.

Basic Information

Item	Detail
Product Name	Ramipril Impurity 17
CAS No.	753405-33-3
Molecular Formula	C23H32N2O5
Molecular Weight	416.52 g/mol
Synonyms	(2S,3aS,6aS)-1-[(2S)-2-[[(1S)-1-Ethoxycarbonyl-3-phenylpropyl]amino]propanoyl]-octahydrocyclopenta[b]pyrrole-2-carboxylic Acid; Ramipril Impurity K; Ramipril Related Compound K; Ramipril EP Impurity K; Ramipril Diacid Ester Impurity; 1-[(2S)-2-[[(1S)-1-Ethoxycarbonyl-3-phenylpropyl]amino]propanoyl]-(2S,3aS,6aS)-octahydrocyclopenta[b]pyrrole-2-carboxylic Acid
EINECS	Contact for details

Quality Control

Every batch of Ramipril Impurity 17 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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) and must be kept in a desiccated environment to maintain stability and purity.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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