Description

Enalapril Impurity 1 is a specified impurity of the antihypertensive drug Enalapril, identified by CAS number 105167-27-9. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical method development and validation required for drug substance quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies focused on ensuring the purity, safety, and efficacy of Enalapril and its related pharmaceutical products.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Enalapril Maleate active pharmaceutical ingredient (API) and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) to meet ICH Q2(R1) and pharmacopeial guidelines.
• Used in stability studies and forced degradation studies to understand the degradation pathways of Enalapril.
• Essential for regulatory compliance and filing, supporting applications to agencies like the FDA, EMA, and PMDA.
• Serves as a research tool in pharmacokinetic and metabolic studies of Enalapril.
• Utilized by quality control (QC) laboratories for routine batch release testing of Enalapril Maleate.
• Important for calibration of analytical instruments used in pharmaceutical impurity profiling.

Basic Information

Product Name	Enalapril Impurity 1
CAS No.	105167-27-9
Molecular Formula	C18H24N2O5
Molecular Weight	348.40 g/mol
Synonyms	(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline; Enalapril Related Compound A; Enalapril Impurity A; Enalapril EP Impurity A; Enalapril USP Related Compound A; (S)-1-[(S)-2-[[(S)-1-Carboxy-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid ethyl ester; N-[(S)-1-Carboxy-3-phenylpropyl]-L-alanyl-L-proline ethyl ester
EINECS	Contact for details

Quality Control

Every batch of Enalapril Impurity 1 is manufactured and controlled under a strict quality management system. Our products undergo rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, NMR), to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to certified reference materials where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. 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
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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