Completeness & Clarity USP testing

Russian translation: испытание Фарм. США «Полнота растворения и прозрачность раствора»

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:Completeness & Clarity USP testing
Russian translation:испытание Фарм. США «Полнота растворения и прозрачность раствора»
Entered by: Igor_2006

05:20 Dec 28, 2019
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals / исследование
English term or phrase: Completeness & Clarity USP testing
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).
Olesya Poleschuk
Kazakhstan
Local time: 11:58
Полнота растворения и прозрачность раствора
Explanation:
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»
Selected response from:

Igor_2006
Russian Federation
Local time: 09:58
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1Полнота растворения и прозрачность раствора
Igor_2006


  

Answers


21 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
completeness & clarity usp testing
Полнота растворения и прозрачность раствора


Explanation:
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)
--------------------------------------------------

испытание Фарм. США «Полнота растворения и прозрачность раствора»

Igor_2006
Russian Federation
Local time: 09:58
Specializes in field
Native speaker of: Russian
PRO pts in category: 1191

Peer comments on this answer (and responses from the answerer)
agree  Marlin31
2 hrs
  -> Спасибо.
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