Description

Lisinopril Impurity 19 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Lisinopril. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations by accurately identifying and quantifying related substances. It is an essential tool for analytical chemists and quality assurance professionals in pharmaceutical R&D, manufacturing, and regulatory affairs.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Lisinopril API and finished dosage forms.
• Method development and validation for HPLC, UPLC, and LC-MS analytical procedures in pharmaceutical quality control laboratories.
• Stability studies and forced degradation studies to monitor impurity profiles and establish shelf-life for Lisinopril-based cardiovascular drugs.
• Supporting regulatory filings (e.g., ANDA, NDA) by providing impurity data for the ICH Q3B (R2) guideline on impurities in new drug products.
• Calibration of analytical instrumentation and systems suitability testing to ensure accurate and reproducible results.
• Research into the degradation pathways and metabolism of Lisinopril.

Basic Information

Product Name	Lisinopril Impurity 19
CAS No.	488760-32-3
Molecular Formula	C21H31N3O5
Molecular Weight	405.49 g/mol
Synonyms	Lisinopril Related Compound 19; (2S)-1-[(2S)-6-Amino-2-[[(1S)-1-carboxy-3-phenylpropyl]amino]hexanoyl]pyrrolidine-2-carboxylic acid; Lisinopril EP Impurity 19; Lisinopril USP Impurity 19; Lisinopril Impurity K; Lisinopril Degradant; N2-[(S)-1-Carboxy-3-phenylpropyl]-L-lysyl-L-proline
EINECS	Contact for details

Quality Control

Every batch of Lisinopril Impurity 19 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic methods, to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided with each shipment and are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and purity.

Specification

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