CEI-MS-09 — Assessment of appearance, cake integrity and reconstitution behaviour
Assessment of appearance, cake integrity and reconstitution behaviour
§1Scope
§1.1Scope
Visual and low-technology assessment of a lyophilised presentation: cake appearance, collapse, shrinkage, colour, reconstitution time, clarity of the reconstituted solution and the presence of visible particulate or fibrillar material.
§2Principle
A collapsed or shrunken cake indicates that the product temperature exceeded the collapse temperature during primary drying, which correlates with elevated residual moisture and reduced solid-state stability. A reconstitution time exceeding two minutes for a small peptide indicates either aggregation or an unfavourable cake structure. A blue solution for a copper-complexed tripeptide indicates intact complexation, and a colourless one indicates the free peptide.[1,2]
§3Apparatus and reagents
§3.1Apparatus
- Visual inspection station with a matt black and matt white background and controlled illumination of 2000–3750 lux
- Timer
- Calibrated diluent dispenser
§3.2Reagents and reference materials
- Diluent appropriate to the preparation, particle-free
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.
- 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
- Carpenter JF, Pikal MJ, Chang BS, Randolph TW. Rational design of stable lyophilized protein formulations: some practical advice. Pharmaceutical Research 1997;14(8):969–975. doi:10.1023/a:1012180707283 · PMID 9279875
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.