Description

Clevidipine Impurity 6 CAS NO 175688-79-6 is a high-purity reference standard used in the analytical profiling of the antihypertensive drug Clevidipine. This compound is critical for pharmaceutical quality control and regulatory compliance, enabling the accurate identification and quantification of process-related impurities. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical development and manufacturing, ensuring drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for method development and validation in HPLC and LC-MS analysis.
• Impurity Identification and Profiling: Used to identify, characterize, and quantify Clevidipine Impurity 6 in active pharmaceutical ingredient (API) batches and finished drug products.
• Quality Control and Assurance (QC/QA): Integral for routine quality control testing to ensure Clevidipine API meets stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Clevidipine to monitor impurity formation over time.
• Research and Development (R&D): Used in process chemistry R&D to understand and optimize synthesis pathways to minimize this specific impurity.

Basic Information

Product Name	Clevidipine Impurity 6
CAS No.	175688-79-6
Molecular Formula	C21H23Cl2NO6
Molecular Weight	456.32 g/mol
Synonyms	1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid methyl 1-(phenylmethyl)-3-piperidinyl ester; Methyl 1-benzyl-3-{[(3,5-dimethyl-4-(3-nitrophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate]oxy}piperidine-1-carboxylate (related ester derivative); Clevidipine Related Compound; Cleviprex Impurity; Clevidipine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Clevidipine Impurity 6 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, GC) to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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