USP〈2〉ORAL DRUG PRODUCTS—PRODUCT QUALITY TESTS

BRIEFING

〈2〉 Oral Drug Products—Product Quality Tests. This proposal is based on the version of the chapter official as of August 1, 2020. A revision was initiated to align the section of extractables of this chapter with corresponding information contained in The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline Q6A—Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. The relevant official texts on dissolution, disintegration, and nitrosamines were also incorporated. Additional alignment with current guidance from FDA on chewable tablets was also introduced. References to general chapters on extractables and leachables were incorporated for completeness. Other sections were updated for better flow and consistency within the chapter.

Additionally, minor editorial changes have been made to update the chapter to current USP style.

Source from USP and Please refer to USP for details:

https://online.uspnf.com/uspnf/document/2_GUID-DA161518-EC27-4647-AACD-29D28F2A4E92_50101_en-US?

PET amber bottle

28mm child resistant  cap for liquid medicine

5ml oral dosing pipette

10ml oral dosing syringe