USP reference standards
USP reference standards

USP Reference Standards

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USP Reference Standards

Recognized globally, USP Standards accelerate the pharmaceutical drug development process and increase confidence in the accuracy of analytical results. USP Standards are built on deep science, provide a high degree of analytic rigor and are accepted by regulators around the world. USP Standards support every stage of drug development and manufacturing, saving time and resources which contribute to the acceleration of the development of quality medicines.

The use of USP Standards (Pharmacopeial Reference Standards and Pharmacopeial Documentary Standards Method) enables companies to operate with a high level of certainty and confidence, reducing the risk of incorrect results that could lead to unnecessary batch failures, product delays, and market withdrawals.

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Resources

Reference Standards Catalog

USP currently offers more than 3,500 Reference Standards—highly characterized specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagents and performance calibrators. Click below to download the full list.

 

new reference standards

New Releases

Access the USP Store to see a list of new product releases.

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Upcoming reference standards releases

Upcoming Releases

See a list of upcoming product releases.

See upcoming releases

Quality Solutions Sheets

A compilation of documentary standards and physical materials related to a drug substance or product – all in one place.

Access the Quality Solutions Sheets
USP–NF online

USP–NF Updates

See USP–NF and Pharmacopeial Forum updates.

Access USP-NF

Featured Products & Solutions

Kinase Inhibitors

USP’s standards and solutions – well accepted by regulators worldwide – play a critical role in accelerating drug development and minimizing risks for manufacturers seeking to release and gain approval of kinase inhibitors. USP provides official Reference Standards for active pharmaceutical ingredients and impurities, Pharmaceutical Analytical Impurities (PAIs), nitrosamine impurities, excipients, and validated methods in USP−NF monographs for our portfolio of kinase inhibitor solutions.

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Please note: some links below require a USP-NF account to access.

Erlotinib Hydrochloride - COMING SOON

Erlotinib Tablets - COMING SOON

Included General Chapters:

Included Excipients:

Erlotinib

Erlotinib

Please note: some links below require a USP-NF account to access.

Erlotinib Hydrochloride - COMING SOON

Erlotinib Tablets - COMING SOON

Included General Chapters:

Included Excipients:

Please note: some links below require a USP-NF account to access.

Everolimus 

Included General Chapters:

Everolimus

Everolimus

Please note: some links below require a USP-NF account to access.

Everolimus 

Included General Chapters:

Please note: some links below require a USP-NF account to access.

Gefitinib

Gefitinib Tablets

Included General Chapters:

Included Excipients:

Gefitinib

Gefitinib

Please note: some links below require a USP-NF account to access.

Gefitinib

Gefitinib Tablets

Included General Chapters:

Included Excipients:

Please note: some links below require a USP-NF account to access.

Nilotinib 

Included General Chapters:

Included Excipients:

Nilotinib

Nilotinib

Please note: some links below require a USP-NF account to access.

Nilotinib 

Included General Chapters:

Included Excipients:

Please note: some links below require a USP-NF account to access.

Regorafenib

Included General Chapters

Excipients included with this molecule

Regorafenib

Regorafenib

Please note: some links below require a USP-NF account to access.

Regorafenib

Included General Chapters

Excipients included with this molecule

Please note: some links below require a USP-NF account to access.

Sirolimus - COMING SOON

Sirolimus Tablets - COMING SOON

Included General Chapters:

Excipients included with this molecule

Sirolimus

Sirolimus

Please note: some links below require a USP-NF account to access.

Sirolimus - COMING SOON

Sirolimus Tablets - COMING SOON

Included General Chapters:

Excipients included with this molecule

Please note: some links below require a USP-NF account to access.

Sorafenib Tosylate

Sorafenib Tablets

Included General Chapters

Excipients included with this molecule:

Pharmaceutical Analytical Impurities:

Sorafenib

Sorafenib

Please note: some links below require a USP-NF account to access.

Sorafenib Tosylate

Sorafenib Tablets

Included General Chapters

Excipients included with this molecule:

Pharmaceutical Analytical Impurities:

Sunitinib Malate - COMING SOON

Included General Chapters:

Included Excipients:

Pharmaceutical Analytical Impurities

Sunitinib

Sunitinib

Sunitinib Malate - COMING SOON

Included General Chapters:

Included Excipients:

Pharmaceutical Analytical Impurities

Performance Verification Testing

Performance Verification Testing

A new standard for Performance Verification Testing (PVT) is now available.

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anticoagulants

Direct Oral Anticoagulants

Standards and solutions for anticoagulant drug development.

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Impurities

Nitrosamines

USP offers a growing catalog of Nitrosamine impurities.

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