Description

Nifedipine Impurity 9 CAS NO 87625-92-1 is a designated pharmaceutical reference standard used for the identification, qualification, and quantification of a specific process-related impurity in Nifedipine Active Pharmaceutical Ingredient (API) and finished drug products. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of cardiovascular medications containing Nifedipine. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on analytical method development and validation.

Application

• Pharmaceutical Impurity Profiling and Characterization: Primary use as a certified reference material for identifying and quantifying Impurity 9 in Nifedipine drug substances and products.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical standard for developing, optimizing, and validating stability-indicating assay methods per ICH Q2(R1) guidelines.
• Quality Control and Batch Release Testing: Used in routine QC testing to monitor impurity levels against strict pharmacopeial limits (e.g., USP, EP, ICH Q3B).
• Stability Studies and Forced Degradation Testing: Employed to track the formation of this specific impurity under various stress conditions (light, heat, humidity) to establish product shelf-life.
• Regulatory Submissions and Compliance: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and responses to regulatory agency inquiries.
• Research into Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Nifedipine to improve formulation stability.

Basic Information

Product Name	Nifedipine Impurity 9
CAS No.	87625-92-1
Molecular Formula	C17H18N2O6
Molecular Weight	346.34 g/mol
Synonyms	Nifedipine Impurity 9; 1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic Acid Dimethyl Ester Nitroso Derivative; Nitroso Nifedipine; Nifedipine Nitroso Impurity; Nifedipine Related Compound 9; Dimethyl 1,4-dihydro-2,6-dimethyl-4-(2-nitrosophenyl)pyridine-3,5-dicarboxylate; 4-(2-Nitrosophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic Acid Dimethyl Ester
EINECS	Contact for details

Quality Control

Every batch of Nifedipine Impurity 9 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (CoA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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. This material is strictly light-sensitive (protect from all light exposure).

Specification

Item	Specification
Appearance	Yellow to orange solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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