Description

Ramipril Related Compound A (20 mg), chemically designated as (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-(Methoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-octahydro-cyclopenta[b]pyrrole-2-carboxylic acid, is a high-purity pharmaceutical reference standard. This compound is critically important for quality control and analytical research in the development and manufacturing of Ramipril, a widely prescribed ACE inhibitor. It is essential for pharmaceutical R&D laboratories, quality assurance departments, and regulatory bodies to ensure drug purity, safety, and efficacy. The product is supplied as a precisely weighed 20 mg unit to guarantee consistency and accuracy in analytical applications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Ramipril Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in compliance with ICH Q2(R1) guidelines.
• Quality Control & Assurance: Used in routine QC testing to monitor and control the level of this specific related substance during Ramipril manufacturing to meet pharmacopeial specifications (USP, EP, BP).
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Ramipril.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate control over product-related impurities.
• Academic & Clinical Research: Supports metabolic and pharmacokinetic studies related to Ramipril.

Basic Information

Product Name	Ramipril Related Compound A (20 mg)
CAS No.	91224-69-0
Molecular Formula	C23H32N2O5
Molecular Weight	416.51 g/mol
Synonyms	(2S,3aS,6aS)-1-[(S)-2-[[(S)-1-(Methoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]octahydrocyclopenta[b]pyrrole-2-carboxylic Acid; Ramipril Impurity A; Ramipril Related Substance A; 1-[(2S)-2-[[(1S)-1-(Methoxycarbonyl)-3-phenylpropyl]amino]propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic Acid; Ramipril EP Impurity A; Ramipril USP Related Compound A; (S,S,S)-Ramipril Diastereomer; Ramipril Degradation Product.
EINECS	Contact for details

Quality Control

Our Ramipril Related Compound A is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is fully characterized and supplied with a comprehensive Certificate of Analysis (COA) that includes data for identity, purity, and assay. The quality is controlled in accordance with relevant pharmacopeial guidelines (USP, EP) and ICH regulatory requirements. Certificates of Analysis are available for every batch upon request.

Storage

Preserve in the original, tightly closed container as supplied. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is both light-sensitive (store away from light) and hygroscopic (moisture-sensitive). Protect from moisture and prolonged exposure to light. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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