Description

Apalutamide is a potent, nonsteroidal androgen receptor (AR) antagonist developed for the treatment of prostate cancer. This high-purity active pharmaceutical ingredient (API) is critical for pharmaceutical manufacturers developing targeted therapies for non-metastatic and metastatic castration-resistant prostate cancer (nmCRPC and mCRPC). It is essential for R&D laboratories, formulation scientists, and commercial-scale API producers focused on oncology drug development and manufacturing.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of finished dosage forms for prostate cancer treatment.
• Oncology Research: Key reference standard and biochemical tool for studying androgen receptor signaling pathways and resistance mechanisms.
• Formulation Development: Used in pre-formulation and formulation studies for solid oral dosage forms like tablets.
• Generic Drug Manufacturing: Serves as the core API for companies developing generic versions of branded prostate cancer medications.
• Clinical Trial Material (CTM) Production: Supplied under GMP conditions for the production of batches used in clinical studies.
• Combination Therapy Research: Investigated in combination with other hormonal therapies or agents for enhanced therapeutic efficacy.

Basic Information

Product Name	Apalutamide
CAS No.	956104-40-8
Molecular Formula	C21H15F4N5O2S
Molecular Weight	477.44 g/mol
Synonyms	ARN-509; JNJ-56021927; 4-[7-[6-Cyano-5-(trifluoromethyl)pyridin-3-yl]-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide; N-{4-[6-Cyano-5-(trifluoromethyl)-3-pyridinyl]-5,7-dioxo-6-thioxo-2,4-diazaspiro[3.4]oct-2-yl}-2-fluoro-N-methylbenzamide
EINECS	Contact for details

Quality Control

Our Apalutamide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, suitable for pharmaceutical applications. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere packing to maintain stability.

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% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

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