Description

Clevidipine Butyrate Impurity L CAS NO 91854-03-4 is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the antihypertensive drug Clevidipine Butyrate by accurately identifying and quantifying this specific impurity. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on cardiovascular drug development and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Clevidipine Butyrate Impurity L in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) protocols.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure drug substance and product meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions (thermal, photolytic, hydrolytic) to establish drug shelf-life.
• Regulatory Submissions: Provides essential data for impurity characterization reports required by regulatory bodies like the FDA and EMA for New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs).
• Research and Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis routes to minimize this specific impurity.

Basic Information

Product Name	Clevidipine Butyrate Impurity L
CAS No.	91854-03-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Clevidipine Butyrate Related Compound L; Clevidipine Impurity L; Clevidipine Butyrate EP Impurity L; Clevidipine Butyrate USP Impurity L; (S)-4-(2,3-Dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic acid methyl 1-[(butyryloxy)methyl]-2-methoxy-2-oxoethyl ester impurity; Clevidipine Butyrate Process Impurity; Clevidipine Butyrate Degradant
EINECS	Contact for details

Quality Control

Our Clevidipine Butyrate Impurity L is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data and batch-specific results are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area. Handle and store under an inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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