Reconstitution calculator: difference between revisions
Diff·revision 26 → 27·14:08, 21 Feb 2025
Difference between revision 26 and revision 27 of Reconstitution calculator. 8 lines changed; the page grew by 798 bytes.
| Revision 26 — 03:16, 11 Feb 2025 MazdutideMads (talk) expand §What the label mass means 4,478 bytes +22 | Revision 27 — 14:08, 21 Feb 2025 SemaglutideSasha (talk) rv — see talk 5,276 bytes +798 | ||
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| 45 | Two rows are worth noticing for a different reason. A 150-unit dose does not fit in a 1 mL insulin syringe, and the tool warns when a computed volume exceeds a plausible barrel. A 5-unit dose sits at the very bottom of a U-100 barrel, where the graduation interval is a large fraction of the dose and precision is correspondingly poor; a lower concentration would place the same dose further up the scale.{{r|iso7886}} | 45 | Two rows are worth noticing for a different reason. A 150-unit dose does not fit in a 1 mL insulin syringe, and the tool warns when a computed volume exceeds a plausible barrel. A 5-unit dose sits at the very bottom of a U-100 barrel, where the graduation interval is a large fraction of the dose and precision is correspondingly poor; a lower concentration would place the same dose further up the scale.{{r|iso7886}} |
| 46 | 46 | ||
| + | 47 | == What the label mass means == | |
| + | 48 | {{main|Peptide content}} | |
| + | 49 | ||
| + | 50 | The calculation above treats the vial's label mass as the mass of peptide present. That is an assumption, and on a [[Certificate of analysis|certificate of analysis]] it is frequently not true. A lyophilised solid contains water ([[Karl Fischer titration|typically 3–8% by mass]]), a [[Trifluoroacetate counterion|counterion]] (2–12%), and residual salts, all of which occupy the labelled mass unless the label claim is explicitly a net peptide figure.{{r|usp1503}} | |
| + | 51 | ||
| + | 52 | A vial labelled 10 mg with 5.2% water and 6.4% trifluoroacetate contains approximately | |
| + | 53 | ||
| 47 | == References == | 54 | == References == |
| 48 | {{reflist}} | 55 | {{reflist}} |
| 49 | <ref name="usp797">United States Pharmacopeia, General Chapter <797>, "Pharmaceutical Compounding — Sterile Preparations". USP–NF, current revision.</ref> | 56 | <ref name="usp797">United States Pharmacopeia, General Chapter <797>, "Pharmaceutical Compounding — Sterile Preparations". USP–NF, current revision.</ref> |
| + | 57 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision.</ref> | |
| 50 | <ref name="iso7886">ISO 7886-1, ''Sterile hypodermic syringes for single use — Part 1: Syringes for manual use''. International Organization for Standardization.</ref> | 58 | <ref name="iso7886">ISO 7886-1, ''Sterile hypodermic syringes for single use — Part 1: Syringes for manual use''. International Organization for Standardization.</ref> |
| 51 | 59 |