Draft standard CEI-MS-12: Residual solvent determination by… — 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. Quantitative claims are reproduced without the method that produced them — arising from DRAFT-RESIDUAL-SOL/008. 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.
2. The limitations section states what the method cannot do but not what a reader will wrongly conclude — arising from DRAFT-RESIDUAL-SOL/005. The limitations section now lists the specific conclusions a conformant determination does not support, each stated as a sentence a reader could otherwise have written, and the list is placed before the references rather than in an annex.
3. Terms are used in senses that differ from established pharmacopoeial usage — arising from DRAFT-RESIDUAL-SOL/011. The three terms now follow established pharmacopoeial usage, the glossary records the definition and its source, and where the Institute uses a term in a narrower sense the departure is stated at first use in the standard.
4. Nothing requires the report to state who performed the determination — arising from DRAFT-RESIDUAL-SOL/010. The report now requires the identity of the laboratory that performed the determination, its accreditation status where claimed, and a statement of whether the releasing party is the performing party, with the fields classified as critical.
5. A single method cannot support the conclusion the standard permits — arising from DRAFT-RESIDUAL-SOL/004. The standard now distinguishes a determination of the measured quantity, which stands alone, from a conclusion about the material, which requires a named orthogonal determination, and states that the second claim made on the strength of the first alone is not…
6. The standard does not state that a determination on one unit says nothing about the batch — arising from DRAFT-RESIDUAL-SOL/015. 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…
7. A field classified as critical is not one a reading turns on — arising from DRAFT-RESIDUAL-SOL/014. The classification test is now stated in the standard: a field is critical where its absence changes the meaning of a reported figure or prevents attribution to a batch. One field has been reclassified under that test and the reasoning recorded.
8. A determination does not record the version of the standard it was made under — arising from DRAFT-RESIDUAL-SOL/007. 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.
9. References should carry a persistent identifier for every cited source — arising from DRAFT-RESIDUAL-SOL/002. Every reference without a persistent identifier now carries an explicit statement that the identifier is not held by the Institute, so that its absence is a recorded fact rather than an apparent oversight.
10. Results are reported without an estimate of measurement uncertainty — arising from DRAFT-RESIDUAL-SOL/012. 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.
11. Nothing requires a laboratory to demonstrate ongoing performance — arising from DRAFT-RESIDUAL-SOL/006. The standard now requires that system suitability results be trended across runs and that a determination report whether the trend was within the laboratory's stated limits, which places the demonstration inside the document the Institute can read.
12. Rounding conventions are not stated and change the reported result — arising from DRAFT-RESIDUAL-SOL/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.
13. The standard would be applied more consistently with a worked example — arising from DRAFT-RESIDUAL-SOL/003. 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.

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.