Description

Cleviprex Impurity J CAS NO 74073-26-0 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the antihypertensive drug Clevidipine. This compound is critical for pharmaceutical research and development, serving as a key marker for ensuring drug purity, safety, and regulatory compliance. It is primarily required by analytical laboratories, quality control units, and R&D departments within the pharmaceutical industry for method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quantitative and qualitative analysis of Clevidipine (Cleviprex) active pharmaceutical ingredient (API) and finished drug products.
• Method Development and Validation: Essential for developing and validating sensitive analytical methods, such as HPLC and LC-MS, to detect and quantify this specific impurity.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity profiles, ensuring batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Used to identify and track the formation of degradation products in stability samples under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Clevidipine.

Basic Information

Item	Detail
Product Name	Cleviprex Impurity J
CAS No.	74073-26-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Clevidipine Impurity J; Clevidipine Related Compound J; Ethyl 4-(2,3-Dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate; 1,4-Dihydro-2,6-dimethyl-4-(2,3-dichlorophenyl)-3,5-pyridinedicarboxylic acid diethyl ester; Clevidipine EP Impurity J; Clevidipine USP Impurity J
EINECS	Contact for details

Quality Control

Every batch of Cleviprex Impurity J is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including chromatographic purity and spectroscopic confirmation. A detailed Certificate of Analysis (COA) is supplied with each shipment, documenting compliance with specified standards. Our quality protocols are designed to meet the rigorous demands of pharmaceutical impurity analysis and regulatory requirements.

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 in a dry environment. For long-term storage, consider storing under an inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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