английский => русский Медицина Медицина: Фармацевтика

Solution containing approximately 0.5% bibenzooxazole acid impurity (a known process impurity) and potential degradant RX-01 acid were injected.
Tafamidis meglumine samples were subjected to thermal and photo stressed study.
Thermal stress study was conducted at 60 °C for 5, 10 and 15 days.
60 °C for up to 15 days was chosen as the stress condition as gelatin shell is not stable at higher temperatures.
Tafamidis meglumine samples were also subjected to ICH option 2 photo stress condition.
Acceptance Criteria
There should be no interference of the active peak from potential degradants, drug substance process impurities, RX-01 acid, blank related peaks and excipient related peaks (Rs ≥ 1.5 from active peak).
Peak purity of the tafamidis peak performed on an Agilent system should have a peak purity factor ≥ 995 for all forced degradation samples.
There should be no interference between specified (known) related substances from each other (Rs ≥ 1.0).
RESULTS
All results met acceptance criteria.
Chromatograms of specificity study are presented in Figure 3.2.P.5.3-1 to .
The peak purity of the tafamidis peak from the forced degradation study is shown in
.
The results met acceptance criteria for all stressed samples.
Figure 3.2.P.5.3-.
Example Chromatogram of the Filtered Diluent (blank)

Подписи под точками на графике: R TA *BI*