EU chem.

[zvezdochka230107]

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EU
Выражение встречается в следующем контексте:
The formulation and manufacturing process for PEG-IFN alfa-2b drug product
is identical to the currently approved formulation and manufacturing process for
PEG-Intron 50-150µg strength vials (Hepatitis-C) with the exception of the varying
amount of drug substance. Therefore, the EU harmonised specification limits
proposed for PEG-Intron Powder for Injection 50µg to 150µg strengths (Hepatitis-C)
will also be applied to PEG-IFN alfa-2b 200µg to 600µg high strength vials
(Oncology) (as outlined in ~xr1i ) based on the following justification:

и еще здесь
The data reported in Table 6 were generated using Superdex HR column
method. While the YMC Diol method specification limit for Di-PEG-IFN of ≤7.7% is
provided on previous page, the Superdex batch results in Table 6, in all cases meet
the EU-based Superdex specification limit for Di-PEG-IFN of ≤7.2%.
Заранее спасибо

[DpoH]

European Union