Description

Nifedipine Impurity 10 is a specified impurity used in the analytical profiling and quality control of the antihypertensive active pharmaceutical ingredient (API) Nifedipine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and regulatory compliance of their drug products. It serves as a key reference standard for method development, validation, and routine testing in the pharmaceutical industry.

Application

• Primary use as a pharmaceutical reference standard for Nifedipine API quality control.
• Identification and quantification of impurities in Nifedipine drug substances and finished products via HPLC, GC, or LC-MS methods.
• Method development and validation for impurity profiling to meet ICH Q3A, Q3B, and pharmacopoeial guidelines (USP, EP).
• Calibration of analytical instruments for precise impurity detection in Good Manufacturing Practice (GMP) environments.
• Research and development of Nifedipine synthesis pathways and degradation studies.
• Supporting regulatory submissions (e.g., ANDA, NDA) by providing impurity characterization data.

Basic Information

Product Name	Nifedipine Impurity 10
CAS No.	10323-98-5
Molecular Formula	C17H18N2O6
Molecular Weight	346.34 g/mol
Synonyms	Dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate; 1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic acid dimethyl ester; Nifedipine Impurity B (EP); Nifedipine Related Compound B; 2-Nitro Nifedipine Impurity; Nifedipine Nitro Isomer; 4-(2-Nitrophenyl)-1,4-dihydropyridine derivative
EINECS	Contact for details

Quality Control

Every batch of Nifedipine Impurity 10 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including high-performance liquid chromatography (HPLC) for purity assessment and spectroscopic methods for structural confirmation. Certificates of Analysis (COA) detailing batch-specific results are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The compound is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	Yellow to orange crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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