Description

Nilutamide Ep Impurity A is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Nilutamide. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It serves as a key reference marker for method development, validation, and routine batch testing in compliance with stringent pharmacopeial standards like the European Pharmacopoeia (EP).

Application

• Primary use as a certified reference standard (CRS) for Nilutamide impurity analysis.
• Method development and validation for HPLC/LC-MS methods in pharmaceutical QC laboratories.
• Identification and quantification of specific impurities during stability studies of Nilutamide API.
• Calibration of analytical equipment to ensure accurate impurity profiling.
• Supporting regulatory submissions (e.g., ANDA, NDA) by providing impurity characterization data.
• Research and development of advanced purification processes for Nilutamide.
• Quality assurance testing for raw material suppliers and contract manufacturing organizations (CMOs).

Basic Information

Product Name	Nilutamide Ep Impurity A
CAS No.	63612-49-7
Molecular Formula	C12H10F3N3O4
Molecular Weight	317.22 g/mol
Synonyms	5,5-Dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]-2,4-imidazolidinedione; Nilutamide Impurity A; Nilutamide Related Compound A; EP Impurity A of Nilutamide; 2,4-Imidazolidinedione, 5,5-dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]-; Nilutamide Degradant; Nilutamide Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Nilutamide Ep Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to guarantee traceability and reliability for your critical applications.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

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

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