Shenzhen Hybio Pharmaceutical: difference between revisions
Diff·revision 12 → 13·00:00, 24 Oct 2025
Difference between revision 12 and revision 13 of Shenzhen Hybio Pharmaceutical. 13 lines changed; the page grew by 1,143 bytes.
| Revision 12 — 13:04, 14 Oct 2025 EndotoxinEd (talk) fix a broken wikilink 8,150 bytes +399 | Revision 13 — 00:00, 24 Oct 2025 DPP4_Dagmar (talk) correct the trading name — the short code and the legal name are different things 9,293 bytes +1,143 | ||
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| 41 | Water content by [[Karl Fischer titration|Karl Fischer titration]] appears on the certificates described in the submitted set more often than for most entities covered here, and [[Peptide content|peptide content]] is reported on a separate line from chromatographic purity across a substantial part of it.{{r|reports,usp1503}} Those two determinations are what let a purity percentage be read as a statement about mass, and their routine presence is the most useful documentary observation available about this organisation. | 41 | Water content by [[Karl Fischer titration|Karl Fischer titration]] appears on the certificates described in the submitted set more often than for most entities covered here, and [[Peptide content|peptide content]] is reported on a separate line from chromatographic purity across a substantial part of it.{{r|reports,usp1503}} Those two determinations are what let a purity percentage be read as a statement about mass, and their routine presence is the most useful documentary observation available about this organisation. |
| 42 | 42 | ||
| + | 43 | What the record does not establish is the physical arrangement of manufacture, whether synthesis is performed in-house or contracted out, or what quality system governs it. Statements to that effect in the organisation's own material are self-published and are not corroborated here.{{r|selfpub,gmp}} | |
| + | 44 | ||
| 43 | == Product range == | 45 | == Product range == |
| 44 | | Class | Representative listings | Documentation reported | | 46 | | Class | Representative listings | Documentation reported | |
| ⋮ | ⋮ | ||
| 52 | The active-ingredient listings are documented differently from the catalogue lines — a specification sheet rather than a single purity figure, and in places a reference to a [[Drug master file|drug master file]] said to be held with a regulator elsewhere. Whether such a file exists, and what it covers, is not established by any source available to this wiki, and a reader should treat the reference as a claim until it is.{{r|selfpub}} | 54 | The active-ingredient listings are documented differently from the catalogue lines — a specification sheet rather than a single purity figure, and in places a reference to a [[Drug master file|drug master file]] said to be held with a regulator elsewhere. Whether such a file exists, and what it covers, is not established by any source available to this wiki, and a reader should treat the reference as a claim until it is.{{r|selfpub}} |
| 53 | 55 | ||
| + | 56 | == Independent testing record == | |
| + | 57 | Reports on HYB material submitted to PeptidePedia between 2024 and 2026 cover the incretin analogues most heavily, with a smaller set on repair and secretagogue peptides and a handful on bulk raw material. Reported [[Area percent purity|area percent]] figures have been high across the set, and where a report and the accompanying certificate can be compared the two have generally agreed within a few tenths of a percentage point.{{r|reports}} | |
| + | 58 | ||
| 54 | == References == | 59 | == References == |
| 55 | {{reflist}} | 60 | {{reflist}} |
| ⋮ | ⋮ | ||
| 60 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision.</ref> | 65 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision.</ref> |
| 61 | <ref name="ruo">Research-use-only labelling practice; see [[Research use only]] for the legal and commercial function of the phrase.</ref> | 66 | <ref name="ruo">Research-use-only labelling practice; see [[Research use only]] for the legal and commercial function of the phrase.</ref> |
| + | 67 | <ref name="gmp">World Health Organization, ''Good Manufacturing Practices for Pharmaceutical Products: Main Principles'', WHO Technical Report Series. The general framework against which a GMP claim is assessed.</ref> | |
| + | 68 | ||
| + | 69 | == See also == | |
| + | 70 | * [[Certificate of analysis]] | |
| + | 71 | * [[Third-party testing]] | |
| + | 72 | * [[Area percent purity]] | |
| + | 73 | * [[Peptide content]] | |
| + | 74 | * [[Research use only]] | |
| 62 | 75 | ||
| 63 | {{DEFAULTSORT:Shenzhen Hybio Pharmaceutical}} | 76 | {{DEFAULTSORT:Shenzhen Hybio Pharmaceutical}} |