CEI-MS-09 — procedure

§4Procedure

The procedure below is written in the second person, which is the only place in the Institute's document set where that register is used. A procedure is an instruction and is written as one.

1. Inspect the unopened container against both backgrounds and record cake appearance, colour, collapse, shrinkage and any free powder.
2. Add the stated diluent volume down the container wall. Do not shake.
3. Start the timer and record time to complete dissolution with gentle inversion only.
4. Inspect the reconstituted solution against both backgrounds for clarity, colour, visible particulate and fibrillar material.
5. Record the observation with the illumination level and the observer.

References cited on this page

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

1. United States Pharmacopeial Convention. General Chapter ⟨788⟩ Particulate Matter in Injections. United States Pharmacopeia — National Formulary (USP–NF) 2024;USP 2024 Issue 1. identifier not held by the Institute

Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.