Description

Enalapril Impurity 8 (Enalaprilat Ssr Isomer) is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a key impurity for the quality control and analytical validation of the antihypertensive drug Enalapril and its active metabolite, Enalaprilat. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Enalapril and Enalaprilat Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, calibrating, and validating chromatographic methods to meet ICH Q2(R1) and other regulatory guidelines.
• Stability Studies & Forced Degradation: Used to monitor the formation of specific degradation products during drug stability testing under various stress conditions (e.g., heat, humidity, light).
• Pharmacopeial Compliance (USP/EP/BP): Supports testing to comply with monograph specifications for related substances in major pharmacopeias.
• Quality Control & Batch Release: Enables precise impurity profiling to ensure every batch of API or drug product meets pre-defined quality specifications.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity characterization and control strategies.

Basic Information

Product Name	Enalapril Impurity 8 (Enalaprilat Ssr Isomer)
CAS No.	76391-23-6
Molecular Formula	C18H24N2O5
Molecular Weight	348.40 g/mol
Synonyms	Enalaprilat Impurity SSR; (S,S,R)-Enalaprilat; Enalaprilat Diastereomer; (2S)-1-[(2S)-2-[[(1S)-1-Carboxy-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic Acid; SSR Isomer of Enalaprilat; Enalapril Related Compound; Enalapril Impurity F (by some sources); MK-422 Impurity.
EINECS	Contact for details

Quality Control

Every batch of Enalapril Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with industry and regulatory standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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