USP Standards and Solutions for Kinase Inhibitor
USP Standards and Solutions for Kinase Inhibitor

USP Standards and Solutions for Kinase Inhibitors

Confidence in Quality Throughout the Drug Development and Manufacturing Lifecycle

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Kinase Inhibitors

USP standards for kinase inhibitors are more than benchmarks, they’re enablers of innovation and trust. Whether you're working on research & development, drug impurity profiling, or compendial compliance, USP provides scientifically rigorous monographs and reference standards trusted by regulators to help deliver quality with consistency and confidence. 

Discover our newly launched Alectinib Hydrochloride Reference Standard and proposed Monographs designed to support your generic development. We’re expanding our portfolio with Dasatinib standards and solutions, coming soon to further strengthen your toolkit for targeted therapies.

Available Reference Standards

Click below for our portfolio of USP kinase inhibitor solutions:

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard". 

USP Reference Standards:

Included General Chapters: 

Included Excipients: 

Alectinib-New

Alectinib-New

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard". 

USP Reference Standards:

Included General Chapters: 

Included Excipients: 

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard".

USP Reference Standards:

Included General Chapters: 

Included Excipients: 

Dasatinib-Coming soon

Dasatinib-Coming soon

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard".

USP Reference Standards:

Included General Chapters: 

Included Excipients: 

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard".

USP Reference Standards:

Included General Chapters:

Included Excipients:

Erlotinib

Erlotinib

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard".

USP Reference Standards:

Included General Chapters:

Included Excipients:

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard".

USP Reference Standards:

Included General Chapters:

Everolimus

Everolimus

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard".

USP Reference Standards:

Included General Chapters:

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard". 

USP Reference Standards:

Included General Chapters:

Included Excipients:

Gefitinib

Gefitinib

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard". 

USP Reference Standards:

Included General Chapters:

Included Excipients:

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard".

USP Reference Standards:

Included General Chapters:

Included Excipients:

Nilotinib

Nilotinib

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard".

USP Reference Standards:

Included General Chapters:

Included Excipients:

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard".

USP Reference Standards:

Included General Chapters:

Excipients included with this molecule:

Regorafenib

Regorafenib

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard".

USP Reference Standards:

Included General Chapters:

Excipients included with this molecule:

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard".

USP Reference Standards:

Included General Chapters:

Excipients included with this molecule

Sirolimus

Sirolimus

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard".

USP Reference Standards:

Included General Chapters:

Excipients included with this molecule

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard". 

USP Reference Standards:

Included General Chapters:

Excipients included with this molecule:

Pharmaceutical Analytical Impurities:

Sorafenib

Sorafenib

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard". 

USP Reference Standards:

Included General Chapters:

Excipients included with this molecule:

Pharmaceutical Analytical Impurities:

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard".

USP Reference Standards:

Pharmaceutical Analytical Impurities:

Included General Chapters:

Included Excipients:

Pharmaceutical Analytical Impurities

Sunitinib

Sunitinib

Please note that some links below require a USP-NF account to access. "RS" refers to a "USP Reference Standard".

USP Reference Standards:

Pharmaceutical Analytical Impurities:

Included General Chapters:

Included Excipients:

Pharmaceutical Analytical Impurities

*Pharmaceutical Analytical Impurities are released using a process developed by USP’s subject matter experts. The release process is based on internal policies, standard operating procedures, and requirements as defined by USP’s Quality Management System. USP is an ISO 9001:2015 certified facility. PAI products are different from official USP Reference Standards. PAI products are not required for compendial compliance.

Enabling Precision Therapies with Trusted Standards

Enabling Precision Therapies with Trusted Standards

Kinase inhibitors are targeted small molecule therapies that regulate key cellular functions, offering precision treatment for advanced cancers and transplant care based on individual genetic mutations. The above listed drugs are widely used and have significantly improved outcomes and quality of life. The availability of generics expands global access to these life-changing therapies. 

However, developing kinase inhibitors requires robust analytical strategies to ensure pharmaceutical quality, safety, and efficacy, especially in solubility, bioavailability, impurity profiling, metabolite identification, pharmacokinetics, and dissolution variability. USP supports manufacturers with solutions tailored to address these complexities and help empower the delivery of high-quality products and expand access to these therapies worldwide.

Confidence in Quality with USP Standards and Solutions

Confidence in Quality with USP Standards and Solutions

USP standards are globally trusted by regulators and play a critical role in supporting accelerated drug development and help mitigate risk for manufacturers seeking product approval and release. 

Benefits of using USP Kinase Inhibitor solutions: 

  • Rely on Monographs & well-characterized Reference Standards for APIs and impurities tailored to help address analytical complexities
  • Support regulatory confidence and compendial compliance
  • Help accelerate development with reproducible, regulator-recognized methods
  • Access support through USP–NF general chapters and excipient standards , as well as USP’s new Analytical Reference Materials and Pharmaceutical Analytical Impurities. 

With comprehensive USP kinase inhibitor resources, manufacturers can operate with greater confidence and increased certainty in their results—helping to ensure quality, safety, and efficacy throughout the drug development and manufacturing process.

Featured Product: Alectinib

Featured Product: Alectinib

 

Alectinib is a next-generation ALK inhibitor for non-small cell lung cancer (NSCLC), offering targeted CNS penetration and improved progression-free survival. However, its poor water solubility poses formulation and analytical challenges, potentially limiting its bioavailability and leading to inaccurate potency measurements. 

To address this, USP’s rigorously characterized Alectinib Hydrochloride Reference Standard (RS) helps support accurate calibration curves. The validated method in the proposed USP Alectinib Capsule Monograph uses a cosolvent system of acetonitrile and trifluoroacetic acid, addressing solubility issues and helping to achieve consistent extraction and chromatographic performance.

FAQs

What are kinase inhibitors?

Kinase inhibitors target enzymes that regulate cell signaling, growth, and division. They have revolutionized treatment for cancers, inflammatory diseases, and transplant rejection.

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What makes kinase inhibitors analytically complex?

Their lipophilic nature and poor solubility require specialized preparation and validated methods to ensure reliable quantification.

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Why do reference standards matter?

Reference standards help in ensuring consistency, accuracy, and compliance, especially critical for complex molecules with challenging physicochemical properties.

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How do USP standards support generic drug development?

USP Monographs, Reference Standardsand reference materials help ensure medicine quality and safety, aiding manufacturers in meeting regulatory requirements and expanding access to life-saving therapies.

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Why Choose USP standards?

USP Reference Standards are developed through a process that includes interlaboratory collaborative testing with a review of characterization data generated; stability testing for determining shelf life and storage conditions; and a monitoring program to ensure continued suitability for use as primary reference standards.

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What happens if a USP Reference Standard is discontinued?

USP notifies customers who purchased the lot within the past 12 months via email and physical mail.

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