Draft standard: bacterial endotoxin testing of peptide presentations
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 records that an…
§1Consultation and window
§1.1Window
- Opened
- 12 October 2025
- Closed
- 9 November 2025
- Duration
- 28 days
- Status
- Closed — the disposition is published
- Document under consultation
- Standard CEI-MS-05
- Submissions received
- 12
§1.2Consultation questions
The secretariat put the following questions. A submission was not required to address them and several did not; the questions record what the Institute was uncertain about rather than restricting what a respondent could raise.
- Are the interference-testing requirements proportionate for peptide matrices at the concentrations typically presented?
- Should the standard specify a limit, or state performance and leave the limit to the intended route of administration?
- Does the standard state clearly enough that a conformant endotoxin result says nothing about sterility?
§1.3How a submission is handled
- Every submission is signed. The Institute publishes no anonymous submission.
- Every submission carries a declared interest. A declaration of no interest is itself a declaration and is recorded as one. A declaration is not a disqualification and the Institute has never given a submission less weight on that ground.
- A submission from an employee of a marketing-authorisation holder is identified as an industry submission on its face, following a unanimous consultation on the conflicts policy.
- Every submission receives a secretariat response and a disposition. Submissions that are not accepted remain published in full; the Institute does not remove a submission because it disagrees with it.
- There is no voting, no reputation score, no reply thread and no editing after receipt.
§1.4Outcome
The standard was amended before ratification. It states performance and declines to set a universal limit, and it now carries an explicit statement that endotoxin content and sterility are separate determinations answering separate questions.
The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.