Description

Nilutamide EP Impurity C is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient Nilutamide by accurately monitoring and controlling related substances. It is an essential material for analytical chemists, quality assurance laboratories, and regulatory affairs professionals working in the pharmaceutical industry. The precise characterization of this impurity is vital for meeting stringent pharmacopoeial standards, including those of the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Nilutamide EP Impurity C in drug substances and products.
• Method Development and Validation: Essential for developing, validating, and transferring analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control (QC) Testing: Used in routine QC testing of Nilutamide bulk API and finished dosage forms to ensure compliance with EP, USP, or ICH guidelines.
• Stability Studies: Employed to monitor impurity profiles during forced degradation and long-term stability studies of Nilutamide formulations.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research and Development: Facilitates impurity profiling and route scouting during the synthetic process development of Nilutamide.

Basic Information

Product Name	Nilutamide EP Impurity C
CAS No.	65274-43-3
Molecular Formula	C12H10F3N3O4
Molecular Weight	317.22 g/mol
Synonyms	5,5-Dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]-2,4-imidazolidinedione; Nilutamide Impurity C; Nilutamide Related Compound C; 3-[4-Nitro-3-(trifluoromethyl)phenyl]-5,5-dimethyl-2,4-imidazolidinedione; Anandron Impurity C; RU 23908 Impurity C; European Pharmacopoeia Nilutamide Impurity C
EINECS	Contact for details

Quality Control

Every batch of Nilutamide EP Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B, European Pharmacopoeia (EP), and other relevant regulatory 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). 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 powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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