Osimertinib API Powder CAS 1421373-65-0

Osimertinib API,AZD9291 powder,CAS 1421373-65-0,EGFR-TKI raw material,targeted therapy API,bulk Osimertinib manufacturer,Shaanxi Sunrise

Source high-purity Osimertinib (AZD9291) API powder (CAS 1421373-65-0) direct from Shaanxi Sunrise. ≥99% HPLC purity for targeted therapy R&D and manufacturing.



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Description

Osimertinib APIAZD9291 • High-Purity Raw Material
Declaration: Intended for industrial manufacturing or scientific research only.
PREMIUM TARGETED THERAPY API

Osimertinib Powder

CAS No.: 1421373-65-0

Product Alias: AZD9291

Assay / Purity≥99.0% (HPLC)
Molecular FormulaC28H33N7O2
Molecular Weight499.61 g/mol
AppearanceLight yellow to yellow powder

Scientific Overview & Manufacturing Excellence

Osimertinib (AZD9291) is an advanced, highly potent active pharmaceutical ingredient (API) utilized extensively in modern biochemical research and targeted therapeutic development. Our facility specializes in the precision chemical synthesis and bulk manufacturing of Osimertinib, consistently achieving a purity profile of ≥99.0% via HPLC analysis.

Produced under stringent quality control protocols, our Osimertinib raw material ensures minimal batch-to-batch variation and exceptional structural integrity. It is designed to support the demanding requirements of global pharmaceutical R&D, from early-stage in-vitro studies to advanced commercial formulation scaling.

Pharmacological Profile & Formulation Applications

Mechanism of Action (MoA)

Osimertinib functions as an irreversible, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). It is chemically engineered to specifically target and bind to the mutated forms of EGFR, most notably the highly resistant T790M mutation, while demonstrating minimal inhibitory activity toward wild-type EGFR.

API Formulation Targets

As a premium raw material, Osimertinib is highly sought after by pharmaceutical formulators and academic institutions researching targeted oncology therapies. It is the primary API of interest for developing specific formulations targeting advanced, metastatic Non-Small Cell Lung Cancer (NSCLC) presenting with EGFR T790M resistance mutations.

Technical Specifications & Logistics

Product IdentityOsimertinib (AZD9291)
Characteristics / AppearanceLight yellow to yellow powder
Test Method & PurityHPLC Analysis; Active Ingredient ≥ 99.0%
Packaging Configurations• R&D Scale: 1g - 100g per Foil bag
• Pilot Scale: 1kg per Foil bag
• Commercial Bulk: 25kg per Drum
Storage ConditionsStore in a dry, cool place and keep sealed.
Shelf Life36 months (under optimal storage conditions)

Frequently Asked Questions (Regulatory & Procurement)

Can you provide the complete COA and HPLC/MS chromatograms for AZD9291?

Yes. Every batch of our Osimertinib API is released with a comprehensive Certificate of Analysis (COA). We provide full analytical data including HPLC chromatograms (confirming ≥99.0% purity), Mass Spectrometry (MS), and H-NMR spectral data to verify absolute structural accuracy and purity.

What is the Minimum Order Quantity (MOQ) for lab research vs. commercial manufacturing?

We provide highly flexible procurement tiers. For research institutions and early-stage formulation R&D, our MOQ starts at 1 gram, securely packaged in protective foil bags. For commercial pharmaceutical manufacturing, we supply bulk volumes efficiently packaged in 1kg foil bags and 25kg fiber drums.

How do you ensure the stability of the API during transit?

Osimertinib requires a dry and cool environment. We utilize premium, multi-layer sealed foil bags with appropriate desiccants to prevent any moisture ingress or light exposure during transit. For global logistics, we partner with specialized chemical freight forwarders to ensure the API arrives in pristine condition.