USP reference standards
USP reference standards

USP Reference Standards

Previous Next

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.

Quick links

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.

See the new releases
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

Atypical Antipsychotics

As global awareness of mental health needs increases, so will the demand for safe, high-quality and effective generic versions of atypical antipsychotics. Rely on USP’s reference standards and solutions for accurate analytical results to accelerate drug development and reduce manufacturing risks.

Click below to explore USP’s solutions for atypical antipsychotic drugs.

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

Included General Chapters:

Excipients included with this molecule:

Aripiprazole

Aripiprazole

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

Included General Chapters:

Excipients included with this molecule:

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

Pharmaceutical Analytical Impurities

Brexpiprazole

Brexpiprazole

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

Pharmaceutical Analytical Impurities

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

Included General Chapters:

Excipients included with this molecule:

Lurasidone - NEW UPDATE

Lurasidone - NEW UPDATE

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

Included General Chapters:

Excipients included with this molecule:

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

USP Monograph Olanzapine

Included General Chapters

Excipients Included with this molecule

Olanzapine

Olanzapine

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

USP Monograph Olanzapine

Included General Chapters

Excipients Included with this molecule

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

Included General Chapters

Included excipients

Paliperidone

Paliperidone

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

Included General Chapters

Included excipients

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

Included General Chapters:

Excipients included with this molecule:

 

Quetiapine

Quetiapine

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

Included General Chapters:

Excipients included with this molecule:

 

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

Included General Chapters:

Excipients Included with this molecule:

Risperidone

Risperidone

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

Included General Chapters:

Excipients Included with this molecule:

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

Included General Chapters:

Excipients included with this molecule:

Ziprasidone

Ziprasidone

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

Included General Chapters:

Excipients included with this molecule:

Kinase Inhibitors

Kinase Inhibitors

Standards and solutions for kinase inhibitors drug development.

Purchase
Performance Verification Testing

Performance Verification Testing

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

Purchase
anticoagulants

Direct Oral Anticoagulants

Standards and solutions for anticoagulant drug development.

Learn more
Impurities

Nitrosamines

USP offers a growing catalog of Nitrosamine impurities.

Browse and purchase