Description

Clevidipine Impurity 17 is a high-purity reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of this specific impurity during the development and manufacturing of the antihypertensive drug Clevidipine. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on ensuring drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods.
• Method Development & Validation: Used in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Clevidipine.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing in API and finished drug product manufacturing to ensure impurity levels meet ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive characterization data for specified impurities.
• Stability Studies: Employed to track the formation and level of this impurity over time under various storage conditions.
• Research & Development: Used in pharmacokinetic, metabolic, and toxicological studies to understand the impurity's profile.

Basic Information

Product Name	Clevidipine Impurity 17
CAS No.	1685245-63-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Clevidipine Related Compound 17; Clevidipine Impurity; Clevidipine EP Impurity; Clevidipine USP Impurity; Clevidipine Process Impurity; (E)-4-(2,3-Dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylic acid 3-(1-oxobutoxy)propyl 5-methyl ester (Related to Clevidipine); Clevidipine Degradant
EINECS	Contact for details

Quality Control

Our Clevidipine Impurity 17 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (NMR, IR, MS) and purity determination by advanced chromatographic techniques (HPLC, GC). We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, impurities, and residual solvents, ensuring traceability and compliance with current pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material may be hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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