Description

Enalapril Ep Impurity H is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a key impurity for the quality control and validation of analytical methods used in the production of the antihypertensive drug Enalapril. It is essential for laboratories and manufacturers requiring precise impurity profiling to ensure drug safety and regulatory compliance. This material is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Enalapril Maleate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Enalapril products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines) for impurity limits.
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability testing of drug substances and products.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity control.
• Research and Development: Facilitates studies on the synthesis pathway, degradation chemistry, and metabolic profiling of Enalapril and related compounds.

Basic Information

Product Name	Enalapril Ep Impurity H
CAS No.	2055735-10-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2S)-1-[(2S)-2-[[(1S)-1-Carboxy-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid; Enalapril Impurity H; Enalapril EP Impurity H; Enalapril Related Compound H; (S,S,S)-Enalapril; Enalapril Diastereomer; Enalapril Impurity (SSS); L-L-L-Enalapril
EINECS	Contact for details

Quality Control

Every batch of Enalapril Ep Impurity H is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. Keep the container sealed to protect the material from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.