Public comment period · §3
Draft standard: determination of chromatographic purity by… — disposition
The disposition of every submission and the amendments that resulted.
§3Disposition and amendments
§3.1Disposition table
Table 1. Every submission with its disposition. Each row links to the submission in full.
| Reference | Respondent | Point raised | Disposition |
|---|---|---|---|
| DRAFT-RP-HPLC-PURI/005 | Dr Wilhelmina Quaresma | Nothing in the standard addresses transfer of the method between laboratories | Accepted in part |
| DRAFT-RP-HPLC-PURI/001 | Dr Quentin Zimmerthal | The standard should require documented operator competence | Not accepted |
| DRAFT-RP-HPLC-PURI/002 | Brigitta Grünbaum-Sowande | The same concept is given three different names in one document | Accepted |
| DRAFT-RP-HPLC-PURI/004 | Dr Theodora Trelawney | The document set should be published in translation | Not accepted |
| DRAFT-RP-HPLC-PURI/003 | Dr Eamon Sandringham-Adu industry | The additional determinations required would materially increase release testing cost | Accepted in part |
| 5 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 1 | 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. |
| Accepted in part | 2 | Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined. |
| Noted, no amendment | 0 | The submission raises a point the Institute accepts but that does not require a change to the draft, most often because the draft already states it elsewhere. The location is given in the response. |
| Not accepted | 2 | The submission is not accepted. The secretariat response gives the reason. A submission that is not accepted remains published in full; the Institute does not remove a submission because it disagrees with it. |
§3.3Resulting amendments
- Nothing in the standard addresses transfer of the method between laboratories — arising from DRAFT-RP-HPLC-PURI/005. The standard now states the maximum difference between laboratories analysing the same sample at which results are treated as agreeing, and requires that a comparison across laboratories state whether that criterion was met.
- The same concept is given three different names in one document — arising from DRAFT-RP-HPLC-PURI/002. A single term is now used throughout for each defined concept, and the glossary entry is linked at first use within each section rather than once per document.
- The additional determinations required would materially increase release testing cost — arising from DRAFT-RP-HPLC-PURI/003. One of the two determinations is now required only where the stated risk factor is present, with the factor defined in the scope, and the other is retained as a universal requirement with the reasoning stated. The submission is identified as an industry…
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.
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. 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.
Compound Evidence Institute · CEI-CP-004/3 · https://compoundevidence.com/comment-periods/draft-rp-hplc-purity-standard/disposition/ · retrieved 30 July 2026