Certificate of analysis: difference between revisions
Diff·revision 22 → 23·23:21, 11 May 2025
Difference between revision 22 and revision 23 of Certificate of analysis. 3 lines changed; the page grew by 497 bytes.
| Revision 22 — 18:48, 28 Apr 2025 CategoryBot (talk) bot: update parent category chain 8,096 bytes +583 | Revision 23 — 23:21, 11 May 2025 BlindSampleBrid (talk) add category for certificates of analysis 8,593 bytes +497 | ||
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| 61 | # the [[Peptide content|peptide content]], or the counterion identity and content from which it can be derived. | 61 | # the [[Peptide content|peptide content]], or the counterion identity and content from which it can be derived. |
| 62 | 62 | ||
| + | 63 | Requests of this kind are made against the lot identifier printed on the vial. The supplier articles on this wiki each record, under §Ordering and availability, which of the four that organisation supplies as standard and which it supplies on request.{{r|reports}} | |
| + | 64 | ||
| 63 | == References == | 65 | == References == |
| 64 | {{reflist}} | 66 | {{reflist}} |
| 65 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision. Describes the determinations that together characterise a synthetic peptide, and why purity alone does not.</ref> | 67 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision. Describes the determinations that together characterise a synthetic peptide, and why purity alone does not.</ref> |
| 66 | <ref name="iso17025">ISO/IEC 17025:2017, ''General requirements for the competence of testing and calibration laboratories''. International Organization for Standardization. The standard against which a testing laboratory's competence is assessed; self-description is not assessment against it.</ref> | 68 | <ref name="iso17025">ISO/IEC 17025:2017, ''General requirements for the competence of testing and calibration laboratories''. International Organization for Standardization. The standard against which a testing laboratory's competence is assessed; self-description is not assessment against it.</ref> |
| + | 69 | <ref name="reports">Independent test reports and purchaser submissions held by PeptidePedia, 2024–2026. Individual reports on individual samples; they are not a sample of any organisation's output. See [[Blind sampling]].</ref> | |
| 67 | <ref name="ich">International Council for Harmonisation, ''Q6A: Specifications — Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances''. Defines a specification as a list of tests, references to analytical procedures and acceptance criteria; a result reported without one is not a release decision.</ref> | 70 | <ref name="ich">International Council for Harmonisation, ''Q6A: Specifications — Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances''. Defines a specification as a list of tests, references to analytical procedures and acceptance criteria; a result reported without one is not a release decision.</ref> |
| 68 | 71 |