Certificate of analysis: difference between revisions
Diff·revision 14 → 15·08:16, 7 Jan 2025
Difference between revision 14 and revision 15 of Certificate of analysis. 11 lines changed; the page grew by 363 bytes.
| Revision 14 — 11:03, 27 Dec 2024 StyleSheetSybil (talk) clarify that a signature on a certificate is a release, not a verification 6,033 bytes +336 | Revision 15 — 08:16, 7 Jan 2025 ArchiveBot (talk) bot: flag bare reference 6,396 bytes +363 | ||
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| 8 | | Issued by = The supplier, manufacturer or repackager | 8 | | Issued by = The supplier, manufacturer or repackager |
| 9 | | Scope = One named lot | 9 | | Scope = One named lot |
| + | 10 | <!-- Typical content --> | |
| + | 11 | | Core fields = Product, lot, test, specification, result, method, release date | |
| + | 12 | | Frequently absent = Water content, peptide content, counterion, endotoxin | |
| + | 13 | | Standing = Self-published primary document | |
| 10 | }} | 14 | }} |
| 11 | {{hatnote|This article is about the document. For results obtained by a laboratory unconnected with the supplier, see [[Third-party testing]]; for the sampling problem that limits both, see [[Blind sampling]].}} | 15 | {{hatnote|This article is about the document. For results obtained by a laboratory unconnected with the supplier, see [[Third-party testing]]; for the sampling problem that limits both, see [[Blind sampling]].}} |
| ⋮ | ⋮ | ||
| 49 | <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> | 53 | <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> |
| 50 | <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> | 54 | <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> |
| + | 55 | ||
| + | 56 | == See also == | |
| + | 57 | * [[Third-party testing]] | |
| + | 58 | * [[Area percent purity]] | |
| + | 59 | * [[Peptide content]] | |
| + | 60 | * [[Blind sampling]] | |
| + | 61 | * [[Lot traceability]] | |
| 51 | 62 | ||
| 52 | {{DEFAULTSORT:Certificate of analysis}} | 63 | {{DEFAULTSORT:Certificate of analysis}} |