Description

Ramipril Related Compound B (20 Mg) (Ramipril Isopropylester) is a high-purity analytical reference standard and a key process-related impurity in the synthesis of the active pharmaceutical ingredient (API) Ramipril. This compound is critical for pharmaceutical research, development, and quality control, enabling accurate identification and quantification of impurities to ensure drug safety and efficacy. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and validation of cardiovascular medications.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of Ramipril Isopropylester in Ramipril API and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical standard in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor and control process-related impurities, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation of degradation impurities in Ramipril formulations under various stress conditions.
• Chemical Synthesis Research: Used as an intermediate or a marker to study and optimize the synthesis pathway of Ramipril, helping to minimize impurity formation.

Basic Information

Product Name	Ramipril Related Compound B (20 Mg) (Ramipril Isopropylester)
CAS No.	295328-72-2
Molecular Formula	C23H32N2O5
Molecular Weight	416.52 g/mol
Synonyms	Ramipril Impurity B; Ramipril Isopropyl Ester; (2S,3aS,6aS)-1-[(2S)-2-[[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino]propanoyl]-octahydrocyclopenta[b]pyrrole-2-carboxylic acid isopropyl ester; Ramipril EP Impurity B; Ramipril Related Substance B; 1H-Cyclopenta[b]pyrrole-2-carboxylic acid, 1-[(2S)-2-[[(1S)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]octahydro-, 1-methylethyl ester, (2S,3aS,6aS)-; Ramipril Isopropylester Impurity.
EINECS	Contact for details

Quality Control

Our Ramipril Related Compound B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each unit, detailing the results for identity, assay, purity, and related substances. The material is suitable for use in methods validated per ICH guidelines.

Storage

Preserve in the original, tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Assay	95.0% - 105.0% (on dried basis)
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 1.0%

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