Description

Ramipril Related Compound A (30 mg) ((2S,3aS,6aS)-1-[(S)2-[[(S)-1-(methoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-octahydrocyclopenta[b]pyrrole-2-carboxylic acid) is a high-purity reference standard and impurity used in the pharmaceutical development and quality control of the antihypertensive drug Ramipril. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of this specific impurity. It is an essential material for analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the calibration of analytical instruments and the validation of testing methods in compliance with ICH guidelines.
• Impurity Profiling & Control: Used for the identification and quantification of Ramipril Related Compound A as a specified impurity in Ramipril Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Method Development & Validation: A critical component in developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Ramipril.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this related compound under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Quality Control Testing: Integral for routine batch release testing of Ramipril API to ensure it meets the stringent purity specifications outlined in pharmacopeial monographs (e.g., USP, EP).
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Ramipril.

Basic Information

Product Name	Ramipril Related Compound A (30 mg)
CAS No.	108313-11-7
Molecular Formula	C23H32N2O5
Molecular Weight	416.52 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 EP Impurity A; Ramipril Related Substance A; 1-[(2S)-2-[[(1S)-1-(Methoxycarbonyl)-3-phenylpropyl]amino]propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic Acid; (S,S,S)-Ramipril Diastereomer; Ramipril Diacid Ester Impurity.
EINECS	Contact for details

Quality Control

Every batch of Ramipril Related Compound A is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and strength, aligning with current pharmacopeial standards and ICH Q3A/B guidelines for impurities in new drug substances and products. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing results for assay, related substances, residual solvents, and other critical parameters.

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 hygroscopic (moisture-sensitive) and light-sensitive; it must be protected from moisture and stored away from light. For long-term storage under inert atmosphere, please contact us for specific recommendations.

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%
Related Substances (HPLC)	Total impurities: ≤ 2.0% Any individual impurity: ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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