Reconstitution of lyophilised peptides: difference between revisions

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Revision 5 — 03:52, 19 Jul 2024 HypoHildur (talk) expand §Mechanics 2,071 bytes ±0	Revision 6 — 01:19, 30 Jul 2024 StubSorterBot (talk) bot: sort category members 2,816 bytes +745
10	Two quantities determine the resulting concentration: the mass of peptide actually present in the vial, and the volume of diluent added. The first is not the number printed on the label unless [[Peptide content\|content]], water and fill mass are known — a vial nominally containing 5 mg may contain appreciably less peptide. See [[Underfilling]].{{r\|usp1503}}	10	Two quantities determine the resulting concentration: the mass of peptide actually present in the vial, and the volume of diluent added. The first is not the number printed on the label unless [[Peptide content\|content]], water and fill mass are known — a vial nominally containing 5 mg may contain appreciably less peptide. See [[Underfilling]].{{r\|usp1503}}
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+		12	The choice of diluent determines how long the resulting solution can be regarded as usable. [[Bacteriostatic water]] contains a preservative and is used where a container will be entered more than once; [[Sterile water for injection]] contains none. Neither confers sterility on a non-sterile powder.{{r\|usp797}}
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12	== Mechanics ==	14	== Mechanics ==
13	Diluent is directed against the vial wall rather than onto the cake. A jet striking the cake dissolves it violently, generating the air–liquid interfaces and shear at which peptides unfold and aggregate; running the liquid down the wall lets the cake dissolve from beneath.{{r\|manning2010}}	15	Diluent is directed against the vial wall rather than onto the cake. A jet striking the cake dissolves it violently, generating the air–liquid interfaces and shear at which peptides unfold and aggregate; running the liquid down the wall lets the cake dissolve from beneath.{{r\|manning2010}}
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15	Dissolution is completed by gentle swirling or by leaving the vial to stand. Shaking is the practice most likely to produce visible haze, for the same interfacial reason. A cake that has not fully dissolved after several minutes should be given time rather than agitation.	17	Dissolution is completed by gentle swirling or by leaving the vial to stand. Shaking is the practice most likely to produce visible haze, for the same interfacial reason. A cake that has not fully dissolved after several minutes should be given time rather than agitation.
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+		19	Visual inspection after dissolution is informative. A clear, colourless solution free of visible particles is the expected result; haze, particles or fibrous material indicate that the material has changed, whatever the certificate said about the powder. See [[Peptide aggregation]].{{r\|usp1503}}
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17	== References ==	21	== References ==
18	{{reflist}}	22	{{reflist}}
19	<ref name="manning2010">Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. "Stability of protein pharmaceuticals: an update." ''Pharmaceutical Research'' 27(4):544–575 (2010). PMID 20143256.</ref>	23	<ref name="manning2010">Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. "Stability of protein pharmaceuticals: an update." ''Pharmaceutical Research'' 27(4):544–575 (2010). PMID 20143256.</ref>
20	<ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref>	24	<ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref>
+		25	<ref name="usp797">United States Pharmacopeia, General Chapter <797>, ''Pharmaceutical Compounding — Sterile Preparations''.</ref>
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22	{{DEFAULTSORT:Reconstitution of lyophilised peptides}}	27	{{DEFAULTSORT:Reconstitution of lyophilised peptides}}