Draft standard CEI-MS-19: Purity determination for peptides… — disposition

§3Disposition and amendments

§3.1Disposition table

Table 1. Every submission with its disposition. Each row links to the submission in full.

§3.2Summary by disposition

Table 2. Counts by disposition, with the meaning of each.

§3.3Resulting amendments

1. The matrix interferes with the determination and no control is required — arising from DRAFT-POORLY-RETAI/001. 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.
2. Nothing prevents a chromatogram being reprocessed until it passes — arising from DRAFT-POORLY-RETAI/003. The standard now requires the processing method and its version to be recorded with every result and the primary data to be retained. A full audit trail is recommended and not required, since it depends on software many laboratories in scope do not run.
3. The reporting threshold is not tied to a demonstrated limit of quantitation — arising from DRAFT-POORLY-RETAI/004. The reporting threshold is now conditional on demonstrating the required signal-to-noise at that threshold within the run, and a determination that cannot demonstrate it reports the achievable threshold instead of the nominal one.
4. The draft prescribes a procedure where it should state performance — arising from DRAFT-POORLY-RETAI/005. The prescriptive clauses are converted to performance requirements, the specific conditions are retained as a worked example clearly labelled as one, and a laboratory using a different validated procedure that meets the stated performance reports a conformant…
5. The standard would be applied more consistently with a worked example — arising from DRAFT-POORLY-RETAI/006. A worked example is added showing the same primary data treated two ways, with both resulting figures stated and the difference between them quantified, so that the consequence of the misapplication is visible rather than described.
6. Nothing states how long a prepared standard solution remains usable — arising from DRAFT-POORLY-RETAI/009. The procedure now requires solution stability to be demonstrated over the period of intended use, and the demonstration to be recorded with the result.
7. The preparation solvent is not specified and changes what is measured — arising from DRAFT-POORLY-RETAI/010. The preparation solvent is now a required reporting field and the procedure names an acceptable range. Specifying one solvent for every material in scope would exclude compounds the standard is intended to cover.
8. Results are reported without an estimate of measurement uncertainty — arising from DRAFT-POORLY-RETAI/011. Every determination now reports the repeatability observed in the run, the reporting precision, and a statement that two results differing by less than the stated repeatability are not distinguishable by this method.
9. Nothing addresses the container the material was held in — arising from DRAFT-POORLY-RETAI/012. Container type and headspace atmosphere are now reported where known, and recorded as not held where they are not, rather than omitted.
10. Rounding conventions are not stated and change the reported result — arising from DRAFT-POORLY-RETAI/013. The standard now requires that no rounding be applied before the reporting step, states the reporting precision for each quantity, and states the rounding convention used at that step.
11. The scope does not say which materials the standard excludes — arising from DRAFT-POORLY-RETAI/014. The scope now states both what the standard applies to and what it does not, with the excluded classes named and, where another standard covers them, cross-referenced.
12. Quantitative claims are reproduced without the method that produced them — arising from DRAFT-POORLY-RETAI/015. Every quantitative claim now carries the determination that produced it at the point of use, and figures obtained by non-comparable methods are no longer presented in the same row or sentence.
13. A determination does not record the version of the standard it was made under — arising from DRAFT-POORLY-RETAI/016. Every determination reported under this standard now carries the standard identifier and version on its face, and a claim of conformance that does not identify the version is recorded by the Institute as not conformant.

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.

1. 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.