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  3. Medical: Pharmaceuticals

maximum impurity

Russian translation: примесь с самым высоким содержанием

19:53 May 26, 2020
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals / response document
English term or phrase: maximum impurity
An authority writes to a pharmaceutical company:

Thus, according to the ICH Q3B and GF XIV guidelines, the maximum daily dose of the drug is from 10 mg to 2.0 g (for this drug, 800 mg) control of unidentified impurities must be at the level of "not more than 0.2 %", and impurities with a content of more than 0.2 % must be identified and, if necessary, qualified (their safety must be confirmed). In this connection: provide data on the study of the stability of the drug, indicating the actual results for the content of identified and unidentified impurities (the data provided shows the actual values for one maximum impurity);
Artyom Timeyev
Russian Federation
Local time: 12:59
Russian translation:примесь с самым высоким содержанием
Explanation:
одна примесь, которой больше всего
Selected response from:

Ksenia ILINSKA
Ukraine
Local time: 10:59
Grading comment
Спасибо!
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +1примесь с самым высоким содержанием
Ksenia ILINSKA
4доминирующая примесь
cherepanov


  

Answers


34 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
примесь с самым высоким содержанием


Explanation:
одна примесь, которой больше всего

Ksenia ILINSKA
Ukraine
Local time: 10:59
Specializes in field
Native speaker of: Native in RussianRussian, Native in UkrainianUkrainian
PRO pts in category: 280
Grading comment
Спасибо!

Peer comments on this answer (and responses from the answerer)
agree  Tatiana Bobritsky (X)
20 mins
Login to enter a peer comment (or grade)

8 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
доминирующая примесь


Explanation:
http://www.booksshare.net/index.php?id1=4&category=biol&auth...
...выделен нужный антиген, а не доминирующая примесь.

http://www.issp.ac.ru/ebooks/disser/Andreev_B_A.pdf
...наиболее распространенными примесями являются алюминий (это чаще всего доминирующая примесь), бор и фосфор.

cherepanov
Ukraine
Local time: 10:59
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 1147
Login to enter a peer comment (or grade)



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