USP <701> Disintegration revision official October 1, 2026, adding a basket for units over 18 mm
Key facts
- Type / category
- Standard / Standard revision
- Status
- Official
- Agency
- USP
- Source date
- Official date
- Sectors
- Supplements
- Standards
- USP <701>
USP posted a Notice of Adoption of Harmonized Standard for General Chapter <701> Disintegration on September 26, 2025. The revision was approved by the Pharmacopeial Discussion Group (PDG), which harmonizes the chapter with the European and Japanese pharmacopoeias, and by the USP General Chapters Dosage Forms Expert Committee. USP lists October 1, 2026 as the official date.
The major change is a second apparatus option: a Test B basket-rack assembly for tablets and capsules longer than 18 mm along their longest axis. USP also edited the full chapter text to match the PDG sign-off version. USP corrected the notice on October 20, 2025.
USP <701> is a drug chapter. For dietary supplements, USP <2040> applies where a monograph calls for it, and some supplement labs use <701> apparatus and procedures in their methods.
What it means for labs
If your lab runs disintegration testing under USP <701>, check whether any products are longer than 18 mm, whether your apparatus includes the Test B basket-rack, and whether SOPs and equipment qualification records reflect the revised chapter that is official from October 1, 2026.
Sources
This summary is for general information and may not reflect later changes. Always check the official source linked above. It isn't legal or regulatory advice, and Micro-Core Consulting isn't affiliated with the agencies or standards bodies named.