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/001 | Dr Liesbeth Nyquist-Obiora | The standard does not state that a determination on one unit says nothing about the batch | Accepted |
| DRAFT-RP-HPLC-PURI/002 | Rukayat Zaleski-Mbeki | The matrix interferes with the determination and no control is required | Accepted |
| DRAFT-RP-HPLC-PURI/003 | Dr Liesbeth Achterberg | The standard should require documented operator competence | Not accepted |
| DRAFT-RP-HPLC-PURI/004 | Dr Jolanta Uttridge | The standard should state a pass limit | Not accepted |
| DRAFT-RP-HPLC-PURI/005 | Dr Abimbola Sotomayor-Ekwueme | Nothing addresses the container the material was held in | 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 | 2 | 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 | 1 | 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
- The standard does not state that a determination on one unit says nothing about the batch — arising from DRAFT-RP-HPLC-PURI/001. Every determination made under this standard now carries a sampling statement recording how many units were sampled, from what population and by what plan, and the standard states that a determination on a single unit supports no inference about any other…
- The matrix interferes with the determination and no control is required — arising from DRAFT-RP-HPLC-PURI/002. An inhibition and enhancement control is now required for every determination under this standard, with stated recovery limits, and a determination reported without it is recorded as not conformant rather than as a low result.
- Nothing addresses the container the material was held in — arising from DRAFT-RP-HPLC-PURI/005. Container type and headspace atmosphere are now reported where known, and recorded as not held where they are not, rather than omitted.
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