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United States Pharmacopeia | USP

The United States Pharmacopeia (USP) describes quality standards for medicines and is continuously updated as USP-NF, a combination of the United States Pharmacopeia and the National Formulary (NF).

What are USP standards and what does USP-NF mean?

  • The USP-NF is a combination of the United States Pharmacopeia (USP) and the National Formulary (NF) and describes quality standards for medicines, outlines analysis methods, and explains terminologies.
  • The USPs were established by law as official benchmarks for quality.
  • USP rules are enforced by the FDA and other U.S. agencies.
  • There are also quality standards for pharmaceutical packaging in the USP-NF. On the one hand, existing standards are referenced and, on the other hand, test methods with limit values are described.

USP standard – ISO/ASTM reference for pharmacists

For the medical and pharmaceutical industries, ZwickRoell offers a comprehensive product portfolio that takes into account the legal framework and applicable standards and regulations, not only in development and production but also in the packaging of medical and pharmaceutical products.

An excerpt of important application descriptions in the field of medicine and pharmaceuticals according to ISO and ASTM standards can be found in our comprehensive web pages on medical and the pharmaceutical industry.

For better orientation for pharmacists, who are not guided as much by normative standards but rather by USP standards, we have provided below an initial comparison of important applications with the corresponding USP chapters in the United States Pharmacopeia.We are committed to expanding and updating this on an ongoing basis.

USP ChapterTitleISO ReferenceFunctional Proficiency Tests
1382>Assessment Of Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery SystemsISO 7886-1Breakaway Force and Glide Force Test
Leakage Test
1382>Assessment Of Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery SystemsISO 11040-4Glide Force Test
Closure System Liquid Leakage Test
Unscrewing Torque of the Tip Cap
Pull-Off Force of the Tip Cap
1382>Assessment Of Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery SystemsISO 11040-6Glide Force Test
Closure System Liquid Leakage Test
Unscrewing Torque of the Tip Cap
Pull-Off Force of the Tip Cap
1382>Assessment Of Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery SystemsISO 11040-8Breakaway Force and Glide Force Test
Leakage Test
Unscrewing Torque of the Tip Cap
Pull-off Force of the Tip Cap
Residual Seal Force (RSF) Test
1382>Assessment Of Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery SystemsISO 11608-3Glide Force Test
Leakage Test
1207>Package Integrity Evaluation—Sterile ProductsResidual Seal Force Test (RSF)
382>Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery SystemsISO 7886-1Breakaway Force and Glide Force Test
382>Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery SystemsISO 11040-4Breakaway Force and Glide Force Test
Pull-Off Force of the Tip Cap
382>Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery SystemsISO 11040-8Breakaway Force and Glide Force Test
Pull-Off Force of the Tip Cap
382>Elastomeric Component Functional Suitability In Parenteral Product Packaging/Delivery SystemsISO 11608-3Breakaway Force and Glide Force Test
Leakage Test

If you have questions about additional USP standards, our medical technology experts are happy to assist!

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