Osimertinib Powder – Pharmaceutical Grade API for Licensed Applications

Osimertinib powder is a pharmaceutical active ingredient used in targeted cancer therapy. It is commonly associated with EGFR-mutated non-small cell lung cancer treatment. Osimertinib is also known as AZD9291 and mereletinib.
In pharmaceutical products, it is commonly used as osimertinib mesylate.
The free base has the molecular formula C28H33N7O2. Its molecular weight is approximately 499.6 g/mol.
Osimertinib mesylate has the formula C29H37N7O5S.  Its molecular weight is approximately 595.7 g/mol.
These chemical identifiers help support reliable material identification. They also assist with analytical testing and quality documentation.

Osimertinib Powder Overview

Osimertinib is a third-generation EGFR tyrosine kinase inhibitor.
It is designed to target specific activating EGFR mutations.
The compound has also been studied for resistant EGFR mutations.
Therefore, it has an important role in targeted oncology research.
The marketed pharmaceutical form is osimertinib mesylate.
However, powder specifications depend on the material form supplied.
For that reason, buyers should verify the exact salt form before use.
They should also verify the applicable analytical documentation.

Our product information is intended for qualified professional buyers.
It can support pharmaceutical development and regulated research activities.
Moreover, technical documentation can help with material qualification.
Typical documentation may include a certificate of analysis.
Additional documents may include specification sheets and analytical data.
Availability and documentation depend on the supplied material grade.

Key Product Features

Osimertinib powder is valued for its defined chemical identity.
It is relevant to pharmaceutical research involving EGFR signaling.
Furthermore, its established chemical profile supports laboratory analysis.
It can be evaluated using validated analytical methods.
These methods may include HPLC and mass spectrometry.
Other suitable methods may be used according to the buyer’s protocol.

The compound is associated with selective EGFR kinase inhibition.
Its approved clinical use is restricted to specific cancer indications.
Therefore, it should not be promoted as a general cancer treatment.
Instead, product use must follow applicable professional requirements.
Regulatory status can also differ between countries and regions.
Buyers should confirm local requirements before purchasing or using it.

Osimertinib Powder Specifications

The following table provides commonly referenced chemical information.
Final specifications should always be confirmed against the supplied batch.

Specification	Osimertinib Free Base	Osimertinib Mesylate
Product name	Osimertinib	Osimertinib mesylate
Common code	AZD9291	AZD9291 mesylate
CAS Number	1421373-65-0	1421373-66-1
Molecular formula	C28H33N7O2	C29H37N7O5S
Molecular weight	499.6 g/mol	595.7 g/mol
Compound class	EGFR kinase inhibitor	EGFR kinase inhibitor
Physical form	Powder	Powder
Intended sector	Pharmaceutical research	Pharmaceutical manufacturing
Analytical control	Batch specific	Batch specific
Documentation	Subject to supply	Subject to supply

The identifiers above are reported in PubChem records.
However, exact commercial specifications can vary by manufacturer.
Therefore, purchasers should review the current certificate of analysis.
CAS numbers should also be checked against the ordered material.

Quality and Analytical Documentation

Quality assurance is important when sourcing pharmaceutical active ingredients.
Each batch should be assessed against defined quality specifications.
Depending on the supplier, documents may include analytical reports.
A certificate of analysis can show batch-specific test results.
It may include assay, identification, purity, and related parameters.
Other documentation can support traceability and material qualification.

For regulated applications, documentation should match the intended use.
Buyers should therefore request appropriate technical documentation beforehand.
They should also confirm storage and handling requirements.
These requirements may differ according to the product form.
Proper controls are especially important for pharmaceutical raw materials.

Pharmaceutical and Research Applications

Osimertinib is associated with targeted treatment of EGFR-mutated NSCLC.
FDA labeling includes several EGFR mutation-positive NSCLC indications.
These include adjuvant therapy after tumor resection.
They also include first-line treatment for metastatic NSCLC.
Additionally, certain locally advanced cases are covered by labeling.
Specific treatment decisions require approved mutation testing.

Osimertinib may also be used with platinum-based chemotherapy.
This applies to certain locally advanced or metastatic NSCLC settings.
The relevant EGFR mutations include exon 19 deletions and L858R.
The FDA approved this combination in February 2024.
Therefore, current regulatory labeling should be checked before use.

Osimertinib has also been used in research on EGFR resistance.
This includes investigations involving the EGFR T790M mutation.
However, laboratory research should not be confused with clinical treatment.
Clinical administration requires appropriate medical supervision and authorization.
Likewise, dosage decisions belong to qualified healthcare professionals.

Suitable Professional Buyers

This material may be relevant to qualified industry professionals.
Potential users include pharmaceutical development organizations and laboratories.
It may also interest analytical and formulation research teams.
However, suitability depends on regulatory and technical requirements.
The correct grade should always match the intended application.

For pharmaceutical development, identity and purity are especially important.
For analytical work, reference characteristics should be clearly documented.
For formulation work, compatibility and quality must be evaluated.
Accordingly, buyers should review technical information before qualification.

Global Supply and Shipping

Worldwide shipping may be available for eligible commercial orders.
However, shipment depends on destination laws and import requirements.
Pharmaceutical ingredients can be subject to strict customs controls.
Therefore, import eligibility should be confirmed before dispatch.
Documentation requirements can also vary by destination country.

International buyers should verify local pharmaceutical regulations first.
They should also ensure that the recipient is properly authorized.
Shipping arrangements should comply with applicable transport requirements.
Likewise, product declarations should accurately identify the material.

Because regulations vary globally, availability can differ by market.
A shipment accepted in one country may require permits elsewhere.
Therefore, buyers should confirm compliance with their local authority.
This approach helps reduce customs and regulatory complications.

Ordering and Compliance Information

Osimertinib is a prescription pharmaceutical active ingredient.
It should not be represented as an over-the-counter product.
Nor should powdered material be marketed for self-treatment.
Use should be limited to legitimate professional and regulated purposes.
Clinical treatment must follow approved prescribing information.

Before procurement, buyers should confirm the required material form.
They should also verify the desired purity specification.
The CAS number should match the intended chemical identity.
Batch documentation should be reviewed before material acceptance.
Where required, additional regulatory documents should also be obtained.

Why Accurate Osimertinib Identification Matters

Accurate product identification supports consistent quality control.
It also reduces confusion between free base and salt forms.
Osimertinib and osimertinib mesylate have different molecular formulas.
They also have different molecular weights and CAS numbers.
Therefore, the correct form should be specified on purchase documents.

Chemical verification can support reliable laboratory workflows.
For example, analytical teams may compare measured data with specifications.
This can help confirm material identity and batch consistency.
Furthermore, strong traceability supports pharmaceutical quality systems.

Osimertinib remains an important targeted oncology compound.
Its clinical applications are closely linked to EGFR mutation status.
Consequently, accurate product information is essential for professionals.
Regulatory labeling should remain the primary clinical reference.

SEO Keywords for Osimertinib Powder

This product page can naturally target several relevant search terms.
Primary keywords include osimertinib powder and osimertinib API.
Additional terms include osimertinib mesylate, AZD9291 powder,
AZD9291 API, osimertinib raw material, and EGFR inhibitor API.
Other useful phrases include pharmaceutical grade osimertinib.
Related terms include osimertinib CAS 1421373-65-0.
For the mesylate form, use CAS 1421373-66-1.
These keywords should be used naturally across the webpage.
Keyword stuffing should be avoided to preserve readability and trust.

Product Information Summary

Osimertinib powder is a specialized pharmaceutical research material.
It has a well-defined chemical identity and established scientific profile.
The compound is widely recognized within targeted oncology research.
Moreover, its EGFR activity has significant pharmaceutical relevance.
For professional buyers, documentation and material identity remain essential.

The exact product grade should be confirmed before any application.
Likewise, analytical results should be reviewed for each supplied batch.
Shipping is subject to destination regulations and import requirements.
Worldwide supply can therefore depend on local legal conditions.

For legitimate professional use, accurate specifications are essential.
Furthermore, transparent documentation supports responsible material sourcing.
Osimertinib should always be handled according to applicable requirements.
Clinical use must follow approved labeling and qualified medical oversight.