Consultations on methodological standard documents
18 consultations on documents of this type.
Consultations
-
Consultation on the draft of CEI-MS-13, which specifies the performance a determination must achieve for method validation and states what the resulting figure does not establish. The draft states performance rather than prescribing a…
13 submissions5 not accepted -
Consultation on the draft of CEI-MS-07, which specifies the performance a determination must achieve for physical quality and states what the resulting figure does not establish. The draft states performance rather than prescribing a fixed…
13 submissions2 not accepted -
Consultation on the draft of CEI-MS-20, which specifies the performance a determination must achieve for stability and states what the resulting figure does not establish. The draft states performance rather than prescribing a fixed…
4 submissions1 not accepted -
Consultation on the draft standard for freeze–thaw and in-use stability assessment of reconstituted peptide solutions. The draft specifies the cycling regime, the hold conditions and the stability-indicating determinations required, and…
15 submissions1 not accepted -
Consultation on the draft of CEI-MS-04, which specifies the performance a determination must achieve for content and states what the resulting figure does not establish. The draft states performance rather than prescribing a fixed…
16 submissions -
Consultation on the draft of CEI-MS-19, which specifies the performance a determination must achieve for chromatographic purity and states what the resulting figure does not establish. The draft states performance rather than prescribing a…
16 submissions3 not accepted -
Consultation on the draft of CEI-MS-11, which specifies the performance a determination must achieve for physical quality and states what the resulting figure does not establish. The draft states performance rather than prescribing a fixed…
12 submissions1 not accepted -
Consultation on the draft of CEI-MS-08, which specifies the performance a determination must achieve for chromatographic purity and states what the resulting figure does not establish. The draft states performance rather than prescribing a…
9 submissions2 not accepted -
Consultation on the draft standard for bacterial endotoxin testing of peptide presentations, which specifies the performance a determination must achieve and the interference testing required before a result can be interpreted. The draft…
12 submissions1 not accepted -
Consultation on the draft of CEI-MS-12, which specifies the performance a determination must achieve for content and states what the resulting figure does not establish. The draft states performance rather than prescribing a fixed…
15 submissions2 not accepted -
Consultation on the draft of CEI-MS-09, which specifies the performance a determination must achieve for physical quality and states what the resulting figure does not establish. The draft states performance rather than prescribing a fixed…
13 submissions2 not accepted -
Consultation on the draft of CEI-MS-06, which specifies the performance a determination must achieve for microbiological quality and states what the resulting figure does not establish. The draft states performance rather than prescribing…
13 submissions2 not accepted -
Consultation on the draft of CEI-MS-10, which specifies the performance a determination must achieve for content and states what the resulting figure does not establish. The draft states performance rather than prescribing a fixed…
16 submissions1 not accepted -
Consultation on the draft of CEI-MS-03, which specifies the performance a determination must achieve for content and states what the resulting figure does not establish. The draft states performance rather than prescribing a fixed…
11 submissions2 not accepted -
Consultation on the draft of CEI-MS-15, which specifies the performance a determination must achieve for documentation and states what the resulting figure does not establish. The draft states performance rather than prescribing a fixed…
12 submissions2 not accepted -
Consultation on the draft of CEI-MS-02, which specifies the performance a determination must achieve for identity and states what the resulting figure does not establish. The draft states performance rather than prescribing a fixed…
6 submissions -
Consultation on the draft standard specifying the minimum data a certificate of analysis must carry before the Institute will treat it as interpretable. The draft classifies each field as critical or recommended and records that a…
13 submissions1 not accepted -
Consultation on the draft of the Institute's first analytical standard, which specifies the performance a chromatographic purity determination must achieve and states, without qualification, that the resulting figure is a relative…
5 submissions2 not accepted