Table 1 Median of triplicates of physicochemical stability tests (F05).

Organoleptic assessment

Blue fluid gel with characteristic odor

pH

5.40

(5.20–5.40)

5.37

(5.37–5.40)

5.21

(5.08–5.31)

MB monomer quantification (A₆₆₃ nm)

2.260

(2.257–2.260)

2.273

(2.269–2.295)

2.301

(2.228–2.362)

D/M ratio (A₆₂₃/A₆₆₃)

0.498

(0.498–0.498)

0.496

(0.496–0.496)

0.502 *

(0.500–0.503)