Description

Nifedipine Impurity C is a specified impurity used in the quality control and analytical profiling of the active pharmaceutical ingredient (API) Nifedipine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key reference standard for method development, validation, and routine quality testing in the production of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Nifedipine API batches.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Assurance & Control (QA/QC): Used in-house by API manufacturers to establish specification limits and ensure batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity characterization data.
• Research & Development: Employed in stability studies to understand degradation pathways and establish shelf-life for Nifedipine formulations.
• Contract Research Organizations (CROs): Utilized by third-party testing labs to provide analytical services to the pharmaceutical industry.

Basic Information

Product Name	Nifedipine Impurity C
CAS No.	111304-31-5
Molecular Formula	C17H18N2O6
Molecular Weight	346.34 g/mol
Synonyms	1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic Acid Dimethyl Ester Impurity C; Dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate Related Compound C; Nifedipine Related Compound C; Nitrendipine Impurity (by structure); Nitro Derivative of Dihydropyridine; 4-(2-Nitrophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylic Acid Dimethyl Ester
EINECS	Contact for details

Quality Control

Every batch of Nifedipine Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic techniques (HPLC, GC) and spectroscopic methods (NMR, MS). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided to ensure traceability and compliance with ICH Q3A, Q3B, and pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept sealed in a desiccated environment and handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	Yellow to light brown powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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