Description

Ramipril Impurity 3 ((S,R,R)-2-Azabicyclo[3.3.0]Octane-3 is a high-purity chemical reference standard, specifically a stereoisomer of a key bicyclic intermediate used in the synthesis of the antihypertensive drug Ramipril. This compound is critical for pharmaceutical research and development, serving as a definitive marker for process control, method validation, and regulatory compliance in API manufacturing. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable impurities for HPLC, LC-MS, and other chromatographic analyses to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification, qualification, and quantification of related substances in Ramipril Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: A critical component for developing and validating stability-indicating HPLC, UPLC, and LC-MS methods in compliance with ICH Q2(R1) and Q3B(R2) guidelines.
• Quality Control & Assurance: Employed in routine QC testing to monitor and control the impurity profile during Ramipril synthesis, ensuring batch-to-batch consistency and compliance with pharmacopeial limits.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate understanding and control of the manufacturing process as per FDA, EMA, and other global health authority requirements.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to track the formation of potential degradants in Ramipril formulations.
• Process Chemistry Research: Serves as a tool for synthetic chemists to study reaction pathways, optimize synthesis, and minimize the formation of this specific stereoisomeric impurity.

Basic Information

Product Name	Ramipril Impurity 3 ((S,R,R)-2-Azabicyclo[3.3.0]Octane-3
CAS No.	1279200-40-6
Molecular Formula	C7H11N
Molecular Weight	109.17 g/mol
Synonyms	(3S,3aR,6aR)-Octahydrocyclopenta[c]pyrrole; (S,R,R)-2-Azabicyclo[3.3.0]octane; (3S,3aR,6aR)-2-Azabicyclo[3.3.0]octane; Ramipril Impurity 3; Ramipril Related Compound 3; Ramipril EP Impurity C; (3S,3aR,6aR)-Octahydro-1H-cyclopenta[c]pyrrole
EINECS	Contact for details

Quality Control

Every batch of Ramipril Impurity 3 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and strength testing using advanced analytical techniques like HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines for impurities and reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

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

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