Glossary entry (derived from question below)
English term or phrase:
Completeness & Clarity USP testing
Russian translation:
испытание Фарм. США «Полнота растворения и прозрачность раствора»
Added to glossary by
Igor_2006
Dec 28, 2019 05:20
4 yrs ago
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English term
Completeness & Clarity USP testing
English to Russian
Medical
Medical: Pharmaceuticals
исследование
During execution of the infusion study, lots AY4782-W (a recently produced, unreleased batch) and R45729 (a stability batch that had recently expired) were Out of Limit (OOL) for Completeness & Clarity USP testing, a test for the presence of visible particles (note that this test is equivalent to the EP Particulate Matter Visible test).
Proposed translations
(Russian)
4 +1 | Полнота растворения и прозрачность раствора | Igor_2006 |
Change log
Dec 29, 2019 15:32: Igor_2006 Created KOG entry
Proposed translations
+1
21 mins
Selected
Полнота растворения и прозрачность раствора
Completeness and Clarity of Solution— Constitute the solution as directed in the labeling supplied bythe manufacturer for the sterile dry dosage form.
A: The solid dissolves completely, leaving no visible residue as undissolved matter.
B: The constituted solution is not significantly less clear than an equal volume of the diluent or ofPurified Water contained in a similar vessel and examined similarly.
https://www.usp.org/sites/default/files/usp/document/harmoni...
В USP из показателей качества приведены «Механические включения» и «Стерильность». Отдельно приведены требования к восстановленным растворам (показатели «Полнота растворения и прозрачность раствора» и «Механические включения»).
https://zapdoc.site/aktualnaya-informaciya4-a-n-mironov-o-ru...
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Note added at 23 мин (2019-12-28 05:43:07 GMT)
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испытание Фарм. США «Полнота растворения и прозрачность раствора»
A: The solid dissolves completely, leaving no visible residue as undissolved matter.
B: The constituted solution is not significantly less clear than an equal volume of the diluent or ofPurified Water contained in a similar vessel and examined similarly.
https://www.usp.org/sites/default/files/usp/document/harmoni...
В USP из показателей качества приведены «Механические включения» и «Стерильность». Отдельно приведены требования к восстановленным растворам (показатели «Полнота растворения и прозрачность раствора» и «Механические включения»).
https://zapdoc.site/aktualnaya-informaciya4-a-n-mironov-o-ru...
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Note added at 23 мин (2019-12-28 05:43:07 GMT)
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испытание Фарм. США «Полнота растворения и прозрачность раствора»
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