Tablet Friability Test: USP <1216>, Ph. Eur. 2.9.7, JP and ChP 0923 Compared
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A friability method that passes under USP <1216> does not automatically document compliance with every other pharmacopoeia a multi-market product has to reference. Each major pharmacopoeia has its own friability chapter, and the numbers belong in your validation protocol only when they come from the current edition of the chapter you are citing.
This page maps the friability chapters and sets out the USP <1216> method values we can source. For Ph. Eur., JP and ChP, check the current edition before you quote a figure.
Which chapter covers friability
| Pharmacopoeia | Friability chapter | Where to check |
|---|---|---|
| USP | <1216> Tablet Friability | Current USP-NF |
| Ph. Eur. | 2.9.7 (BP Appendix XVII G) | Current Ph. Eur. / BP |
| JP | Tablet Friability Test, General Information |
JP XVIII, General Information |
| ChP | 0923 | Current ChP |
JP lists friability under General Information, not under the numbered General Tests. The JP chapter numbered 6.04 is a different test (acid-neutralizing capacity), so do not cite "JP 6.04" for friability.
USP <1216> method values
- Drum speed: 25 ± 1 rpm
- Revolutions: 100
- Sample size: for tablets with a unit weight of 650 mg or less, whole tablets totalling as near as possible to 6.5 g; for tablets heavier than 650 mg, 10 whole tablets
- Limit: maximum mean weight loss of 1.0% in a single test; if the result is doubtful, repeat the test twice and average the three results
For the full procedure, see our tablet friability testing guide for USP <1216>. To check your own result against the 1.0% limit, use the tablet friability calculator.
Choosing the chapter to cite
Cite the chapter of the pharmacopoeia named in the registration or in your customer's specification: USP for the US market, Ph. Eur. for the EU, JP for Japan and ChP for China. If a product is filed in several markets, record the chapter you followed for each one in the validation protocol, and confirm each requirement against the current edition rather than assuming the chapters are identical.
The CJY-300E and these chapters
The Huanghai CJY-300E tablet friability tester has a dual drum (inside diameter 286 mm, depth 39 mm), an adjustable speed of 20–100 RPM and a counter of 1–1,000 laps. Its compliance reference is ChP, USP and BP. See the friability tester collection or send your requirements through our contact page.
Frequently Asked Questions
What is the USP friability limit?
A maximum mean weight loss of 1.0% in a single test. If the result is doubtful, the test is repeated twice and the three results are averaged.
How many tablets are used in the USP <1216> friability test?
For tablets weighing 650 mg or less, whole tablets totalling as near as possible to 6.5 g. For tablets heavier than 650 mg, 10 whole tablets.
Which JP chapter covers tablet friability?
Tablet Friability Test, General Information
Do USP, Ph. Eur., JP and ChP set identical friability requirements?
Do not assume so. Compare the current edition of each chapter. This page quotes numbers only for USP <1216>.