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Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Consultation record

Submissions accepted — page 21

The submission is accepted and the draft is amended as proposed. The amendment is recorded in the amendment log of the document it changed and is traceable to the numbered submission.

Submissions

735 documents · page 21 of 25

Table 1. Submissions with this disposition, on this page.

ReferenceConsultationRespondentPoint raised
DRAFT-RESIDUAL-SOL/003Draft standard CEI-MS-12: Residual solvent determination by static…Dr Quentin ZimmerthalNothing states how long a prepared standard solution remains usable
DRAFT-RESIDUAL-SOL/005Draft standard CEI-MS-12: Residual solvent determination by static…Quentin Whitmarsh-ObiA determination does not record the version of the standard it was made under
DRAFT-RESIDUAL-SOL/007Draft standard CEI-MS-12: Residual solvent determination by static…Professor Bartolomeu Nkosi-LindegaardA conformance claim is not defined and will be made loosely
DRAFT-RESIDUAL-SOL/008Draft standard CEI-MS-12: Residual solvent determination by static…Dr Abimbola Sotomayor-EkwuemeThe standard does not state that a determination on one unit says nothing about the batch
DRAFT-RESIDUAL-SOL/010Draft standard CEI-MS-12: Residual solvent determination by static…Dr Eulalia Sonnenberg-EzeThe standard assumes a reference standard of known assigned content
DRAFT-RESIDUAL-SOL/011Draft standard CEI-MS-12: Residual solvent determination by static…Eamon Sandringham-AduThe search date is not on the face of the document
DRAFT-RESIDUAL-SOL/013Draft standard CEI-MS-12: Residual solvent determination by static…Dr Xenia Nyquist-ObioraTerms are used in senses that differ from established pharmacopoeial usage
DRAFT-STABILITY-IN/002Draft standard CEI-MS-13: Development and validation of a…Ivo MountstephenA determination does not record the version of the standard it was made under
DRAFT-STABILITY-IN/004Draft standard CEI-MS-13: Development and validation of a…Leonhard AchterbergThe matrix interferes with the determination and no control is required
DRAFT-STABILITY-IN/006Draft standard CEI-MS-13: Development and validation of a…Dr Eamon ImmelmannThe draft prescribes a procedure where it should state performance
DRAFT-STABILITY-IN/008Draft standard CEI-MS-13: Development and validation of a…Dr Evander Whitmarsh-ObiNothing states how long a prepared standard solution remains usable
DRAFT-THIRD-PARTY-/001Draft standard CEI-MS-15: Protocol for independent third-party…Dr Lorcan UttridgeThe limitations section states what the method cannot do but not what a reader will wrongly conclude
DRAFT-THIRD-PARTY-/002Draft standard CEI-MS-15: Protocol for independent third-party…Quentin Whitmarsh-ObiA determination does not record the version of the standard it was made under
DRAFT-THIRD-PARTY-/003Draft standard CEI-MS-15: Protocol for independent third-party…Rukayat Zaleski-MbekiThe matrix interferes with the determination and no control is required
DRAFT-THIRD-PARTY-/004Draft standard CEI-MS-15: Protocol for independent third-party…Dr Vasilisa ImmelmannA report may be issued without naming who performed the determination
DRAFT-THIRD-PARTY-/009Draft standard CEI-MS-15: Protocol for independent third-party…Dr Evander Whitmarsh-ObiThe draft prescribes a procedure where it should state performance
DRAFT-THIRD-PARTY-/010Draft standard CEI-MS-15: Protocol for independent third-party…Dr Hortensia HollingworthThe standard permits a purity figure to be described as an assay
DRAFT-THIRD-PARTY-/011Draft standard CEI-MS-15: Protocol for independent third-party…Dr Fitzwilliam Danquah-ÖbergThe reporting threshold is not tied to a demonstrated limit of quantitation
DRAFT-APPEARANCE-S/002Draft standard CEI-MS-09: Assessment of appearance, cake integrity…Dr Liesbeth AchterbergThe limitations section states what the method cannot do but not what a reader will wrongly conclude
DRAFT-APPEARANCE-S/006Draft standard CEI-MS-09: Assessment of appearance, cake integrity…Dr Abimbola Sotomayor-EkwuemeThe standard specifies how to test a unit and not which units to test
DRAFT-APPEARANCE-S/008Draft standard CEI-MS-09: Assessment of appearance, cake integrity…Quentin Whitmarsh-ObiA determination does not record the version of the standard it was made under
DRAFT-APPEARANCE-S/009Draft standard CEI-MS-09: Assessment of appearance, cake integrity…Dr Eamon ImmelmannThe draft prescribes a procedure where it should state performance
DRAFT-APPEARANCE-S/011Draft standard CEI-MS-09: Assessment of appearance, cake integrity…Dr Lorcan UttridgeThe matrix interferes with the determination and no control is required
DRAFT-POORLY-RETAI/001Draft standard CEI-MS-19: Purity determination for peptides not…Dr Zebedee Zaleski-MbekiThe matrix interferes with the determination and no control is required
DRAFT-POORLY-RETAI/004Draft standard CEI-MS-19: Purity determination for peptides not…Dr Melisande Thorsby-NakamuraThe reporting threshold is not tied to a demonstrated limit of quantitation
DRAFT-POORLY-RETAI/005Draft standard CEI-MS-19: Purity determination for peptides not…Dr Eamon ImmelmannThe draft prescribes a procedure where it should state performance
DRAFT-POORLY-RETAI/006Draft standard CEI-MS-19: Purity determination for peptides not…Dr Fenella Steenkamp-FerreiraThe standard would be applied more consistently with a worked example
DRAFT-POORLY-RETAI/009Draft standard CEI-MS-19: Purity determination for peptides not…Dr Quentin ZimmerthalNothing states how long a prepared standard solution remains usable
DRAFT-POORLY-RETAI/013Draft standard CEI-MS-19: Purity determination for peptides not…Dr Kolawole Isaksen-BalogunRounding conventions are not stated and change the reported result
DRAFT-POORLY-RETAI/014Draft standard CEI-MS-19: Purity determination for peptides not…Dr Fitzwilliam Danquah-ÖbergThe scope does not say which materials the standard excludes

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