Shanghai ERP Biotechnology: difference between revisions
Diff·revision 33 → 34·23:20, 2 Nov 2025
Difference between revision 33 and revision 34 of Shanghai ERP Biotechnology. 3 lines changed; the page grew by 617 bytes.
| Revision 33 — 03:22, 30 Oct 2025 PurityClaimPia (talk) fix arithmetic in worked example 6,585 bytes ±0 | Revision 34 — 23:20, 2 Nov 2025 COA_Colwyn (talk) replace primary source with the review 7,202 bytes +617 | ||
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| 53 | Submitted reports on ERP material to July 2026 are concentrated on the incretin range. Reported [[Area percent purity|area percent]] figures have clustered in the high nineties, consistent with accompanying certificates where available.{{r|reports}} | 53 | Submitted reports on ERP material to July 2026 are concentrated on the incretin range. Reported [[Area percent purity|area percent]] figures have clustered in the high nineties, consistent with accompanying certificates where available.{{r|reports}} |
| 54 | 54 | ||
| + | 55 | The set includes two reports in which the purchaser also had the material assayed for [[Bacterial endotoxin test|endotoxin]], both returning results below the reporting limit of the method used. Endotoxin is not a stability property and does not decrease on storage; a below-limit result on one vial is a fact about that vial.{{r|reports,iso17025}} Endotoxin testing is rare in submissions to this wiki and is recorded where it occurs. | |
| + | 56 | ||
| 55 | == References == | 57 | == References == |
| 56 | {{reflist}} | 58 | {{reflist}} |
| ⋮ | ⋮ | ||
| 60 | <ref name="tally">PeptidePedia reception tally (self-reported submissions; '''weak evidence''' — see [[Project:Sourcing guidelines]]). Self-selected sample; period and count stated at each point of use.</ref> | 62 | <ref name="tally">PeptidePedia reception tally (self-reported submissions; '''weak evidence''' — see [[Project:Sourcing guidelines]]). Self-selected sample; period and count stated at each point of use.</ref> |
| 61 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision.</ref> | 63 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision.</ref> |
| + | 64 | <ref name="iso17025">ISO/IEC 17025:2017, ''General requirements for the competence of testing and calibration laboratories''. International Organization for Standardization.</ref> | |
| 62 | <ref name="ruo">Research-use-only labelling practice; see [[Research use only]] for the legal and commercial function of the phrase.</ref> | 65 | <ref name="ruo">Research-use-only labelling practice; see [[Research use only]] for the legal and commercial function of the phrase.</ref> |
| 63 | 66 |