Abiraterone Acetate API

Abiraterone Acetate API
Details:
Abiraterone Acetate API (CAS 154229-18-2) is a highly potent and selective CYP17 inhibitor API, developed specifically for endocrine therapy of metastatic prostate cancer. It is converted to its active form in vivo to comprehensively block androgen synthesis in the testes, adrenal glands and tumor cells, cutting off the key signaling that drives tumor growth at the source.
  • CAS Number 154229-18-2
  • Formula C26H33NO2
  • Storage Store at 15–25°C
  • Documentation EU/US/CANADA/JAPAN/CADIFA/CHINA
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Description
Technical Parameters

HK Neopharm Limited is one of the most reliable manufacturers and suppliers of abiraterone acetate api in China, featured by quality products and good price. Please rest assured to buy abiraterone acetate api in stock here and get quotation from our factory. Customized orders are welcome.

 

Abiraterone Acetate API (CAS 154229-18-2) is a highly potent and selective CYP17 inhibitor API, developed specifically for endocrine therapy of metastatic prostate cancer. It is converted to its active form in vivo to comprehensively block androgen synthesis in the testes, adrenal glands and tumor cells, cutting off the key signaling that drives tumor growth at the source. Clinically used in combination with prednisone, it significantly extends patient survival and provides a core, mechanism-innovative raw material option for metastatic castration-resistant prostate cancer (mCRPC).

 

Technical Specifications

 

 

Product Name

Abiraterone Acetate API

Synonyms

Abiraterone Acetate Powder, Abiraterone Acetate Raw Material

Characteristics

A white or off-white crystalline powder

CAS Number

154229-18-2

Assay

≥99.0% (HPLC, Subject to the COA)

Formula

C26H33NO2

Package

Technical Package

Storage

1. Routine industrial/API storage: Sealed, stored in a cool and dry place, temperature 15–25°C, relative humidity≤60%, protected from light;

2. Research/reagent grade storage: Store frozen at -20°C (stable for a long time), solution can be stored at -80°C (for about 6 months);

Structure

product-236-236

High Purity Abiraterone Acetate API targets the core needs of endocrine therapy for metastatic prostate cancer. Manufactured in compliance with global GMP standards by qualified pharmaceutical enterprises, it undergoes strict end-to-end quality control, featuring qualified purity, stable crystal form and excellent batch-to-batch consistency. As a highly selective CYP17 inhibitor anti-tumor API, it supports formulation R&D, process scale-up and clinical studies, offering solid raw material support for prednisone for prostate cancer regimens.

As trusted China Abiraterone Acetate API manufacturers, we ensure stable supply of Abiraterone Acetate API made in China with consistent high quality.

 

 
 
Product Features

Abiraterone Acetate Raw Material with Aluminum foil bag

Abiraterone Acetate API (CAS 154229-18-2) is a highly selective CYP17 inhibitor that comprehensively blocks the body's androgen synthesis pathway and cuts off the driving signal for prostate tumor growth at the source. With a clear mechanism of action and strong targeting, it provides core pharmacological support for endocrine therapy.

Abiraterone Acetate Raw Material

Produced and refined by GMP-compliant pharmaceutical facilities worldwide, the product implements strict quality control throughout the process. With purity ≥99.0% (HPLC), stable crystal form and excellent batch uniformity, it fully meets pharmacopoeia standards of various countries, laying a solid quality foundation for formulation production and clinical application. We support customized Abiraterone Acetate Powder to meet diverse R&D and production requirements.

The product is fully suitable for R&D, process optimization and scale-up production of prostate cancer-related formulations, and also supports clinical research and innovative drug development. It features strong compatibility and wide applicability, providing reliable raw material support for pharmaceutical pipeline layout and clinical treatment scheme upgrading.

 

It appears as a white to off-white crystalline powder with stable properties. Packaged with professional technical protection and strictly stored and transported at 2–8°C, it effectively maintains quality consistency throughout its shelf life, reduces quality risks during logistics, and adapts to full-chain supply chain demands. We maintain Abiraterone Acetate Raw Material in stock for prompt delivery worldwide.

 

Full-Cycle Quality Control & Consistent Quality

 

Starting from raw material procurement, the product undergoes strict supplier audits and incoming inspections, with key indicators such as critical impurities and residual solvents verified one by one to eliminate potential quality hazards at the source. The full-cycle quality control system covers raw material traceability and initial testing to ensure basic compliance for each batch.

 

 

 

Production strictly follows global GMP guidelines, with real-time monitoring of core processes including reaction parameters, crystallization and drying standards. Automated quality control systems reduce deviation risks, while enhanced batch record traceability achieves standardized and refined production, ensuring stable product quality from the process side.

 

 

As professional China Abiraterone Acetate Raw Material MateriaI suppliers, we uphold strict quality control at every stage.Before delivery, finished products undergo full-item testing covering assay, related substances, moisture, microbial limits and other core indicators, in line with USP/EP standards. Supported by high-precision HPLC equipment, it ensures finished product purity and parameters meet requirements, providing authoritative quality endorsement for delivery.

 

 

The product uses professional sealed packaging with a real-time temperature and humidity monitoring system, strictly following 2–8°C cold-chain storage and transportation. From warehousing and transportation to final delivery, environmental conditions are continuously controlled to avoid moisture, degradation or crystal transformation, maintaining consistent product quality throughout the cycle. We welcome clients to buy Abiraterone Acetate API with full quality assurance.

 

Application Scenarios

 

 

With its highly selective CYP17 inhibitory activity and stable quality, Abiraterone Acetate Raw Material (CAS 154229-18-2) offers extensive and diverse application value in the anti-tumor pharmaceutical field. It covers the entire process from R&D to commercialization and precisely meets industrial demands at different stages, as detailed below:

 

It is suitable for R&D and production of core formulations for metastatic castration-resistant prostate cancer. As a CYP17 inhibitor API, it supports innovative drug formulation development and prescription screening, providing a stable raw material foundation for formulation development across various dosage forms.

 

As a core raw material prednisone for prostate cancer endocrine therapy, it can be used on a large scale in industrial production of clinical drugs, strictly complying with GMP requirements to ensure batch consistency. It supplies compliant, high-quality API to hospitals and pharmaceutical companies to support clinical diagnosis and treatment. Our China High Purity Abiraterone Acetate API factory supports large-scale and stable bulk supply.

Abiraterone Acetate Application Scenarios

 

It is applicable to anti-tumor pipeline development and clinical research projects in pharmaceutical companies and research institutions, supporting process optimization and pilot-scale production. It ensures stable raw material supply from preclinical to clinical stages and reduces R&D quality risks.

 

It meets the API import and export demands of the global pharmaceutical market, complying with quality and registration standards of major markets such as Europe and the US. It provides compliant supply solutions for overseas formulation manufacturers and traders, helping domestic API enter the international supply chain. We offer Bulk Abiraterone Acetate Powder and Abiraterone Acetate API Free Sample for qualification verification.

 

Packaging and Transportation
 
 

As a key link in ensuring the stability of Abiraterone Acetate API (CAS 154229-18-2), packaging and transportation fully comply with GMP and cold-chain logistics standards. A professional protection system is built based on product characteristics, achieving zero loss and zero pollution delivery through refined packaging and full-chain temperature control.

 

Professional customized packaging:

The product uses pharmaceutical-grade double-layer sealed packaging, with a moisture-proof aluminum foil bag inside and a hard light-proof drum outside, effectively isolating moisture, light and external contamination. Packaging specifications can be customized to meet different R&D and production volumes.

 
 

Strict packaging quality control:

All packaging materials undergo compliance testing and microbial limit verification to ensure no impurity precipitation or toxic residue. Packaging is completed in a clean workshop under GMP, with leakproofness sampling for each batch to eliminate transportation risks.

 
 

Full-process temperature-controlled cold-chain logistics:

The product is strictly stored and shipped at 2–8°C with professional cold-chain solutions and real-time temperature monitoring. Insulated boxes and ice packs maintain stable in-transit conditions, ensuring quality consistency for long-distance delivery.

 
 

Full-chain traceable logistics:

A complete logistics traceability system is established covering dispatch, transportation and delivery. Supported by professional documents and temperature records, it meets international pharmaceutical import and export regulations, providing compliant, transparent and reliable end-to-end service.

 

 

 
 
Our Advantages

Compliant Production & Quality Advantage

We own a GMP-compliant production base with strict full-cycle quality control. Product purity is stably≥99.0%, in line with USP/EP standards, with excellent batch consistency. It directly supports clinical formulation production and global market supply with reliable quality.

R&D & Process Advantage

Our professional R&D team focuses on process optimization for CYP17 inhibitor APIs, breaking through core technical bottlenecks to achieve large-scale production with reduced costs. We provide customized process solutions to improve formulation R&D efficiency for clients.

Full-Process Service & Supply Advantage

We have established a full-chain service system covering raw material procurement, production, testing, packaging and transportation. With professional technical and after-sales support, we ensure timely response and stable supply for small-batch R&D and large-scale production demands.

International Compliance & Market Advantage

The product fully meets registration standards of major markets including Europe and the US, with complete certification and testing reports. It smoothly connects to the global pharmaceutical supply chain, helping clients expand overseas markets with cost-effective supply supported by a mature supply system.

 

FAQ

 

Q1: How are genotoxic impurities controlled during production?

A: Through optimized synthetic routes, enhanced crystallization and refining processes, combined with HPLC/LC-MS precise detection, genotoxic impurities are controlled below ICH M7 limits.

Q2: What are the advantages of abiraterone acetate over other prostate cancer drugs?

A: It is a comprehensive androgen synthesis inhibitor that suppresses androgen production at the source rather than merely blocking receptors. With proven efficacy, it is a core API for mCRPC standard therapy.

Q3: How effective are drugs made from Abiraterone Acetate Powder?

A: Clinically proven to significantly control tumor progression and extend patient survival, making it an essential medicine in prostate cancer therapy.

Q4: Will this product be replaced in the future?

A: It remains a mainstream clinical drug. Although new targeted agents may emerge, it will maintain irreplaceable clinical value in the medium to long term.

 

The company adheres to pharmaceutical quality fundamentals and prioritizes patient safety. We specialize in supplying high-purity, stable Abiraterone Acetate Raw Material with standardized production and full traceability of key processes. From R&D trials and formulation optimization to industrial supply, we provide consistent and reliable support for various pharmaceutical projects. We are ready to cooperate with clients worldwide, empower advances in prostate cancer treatment with high-quality raw materials, and build a long-term, mutually trusted and win-win industrial ecosystem.

 

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