Description

Ramipril Impurity 1 ((R,S,S)-2-Azabicyclo[3.3.0]Octane-3 is a key chemical reference standard used in the pharmaceutical development and quality control of the antihypertensive drug Ramipril. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark for impurity profiling and analytical method validation. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams focused on API manufacturing and compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Ramipril Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods for purity analysis.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA, ICH) by providing characterized impurity data for Drug Master Files (DMFs) and Common Technical Documents (CTDs).
• Stability Studies: Used to monitor the formation of degradation products in Ramipril under various stress conditions (e.g., heat, humidity, light) as per ICH guidelines.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Ramipril by identifying and controlling process-related impurities.
• Quality Control (QC) Testing: Routinely used in in-house and third-party QC laboratories to ensure batch-to-batch consistency and compliance with pharmacopeial specifications (USP, EP, BP).

Basic Information

Item	Details
Product Name	Ramipril Impurity 1 ((R,S,S)-2-Azabicyclo[3.3.0]Octane-3
CAS No.	94498-85-8
Molecular Formula	C7H13N
Molecular Weight	111.18 g/mol
Synonyms	(R,S,S)-2-Azabicyclo[3.3.0]octane-3-carboxylic acid; (3S,3aS,6aS)-Hexahydro-2H-cyclopenta[b]pyrrole-3-carboxylic acid; Ramipril Impurity A; Ramipril Related Compound A; 2-Azabicyclo[3.3.0]octane-3-carboxylic acid, (3S,3aS,6aS)-; Perindopril Impurity C (related structure); ACE Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Ramipril Impurity 1 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and strength testing to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters. We support compliance with ICH Q3A/B, USP, and EP guidelines.

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); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.