Strategies to stabilize dalbavancin in aqueous solutions: Section 4—identification of heat degradation products in 2-hydroxypropyl-β-cyclodextrin and divalent metal ion solutions at pH 4.5 and 7.0

AAPS Open

Table 5 The effect of 2HPβCD with and without Ca²⁺ on the yields of degradation products of dalbavancin found after stressing at 70 °C for 5 days in 10 mM acetate buffer

Compound ID	Relative EIC peak intensity^a (%)		Fraction of total HPLC-UV peak area^b (%)
Compound ID	AcB10Cyclod55	AcB10 Ca10Cyclod55	AcB10	AcB10Cyclod55	AcB10Ca10Cyclod55
MAG	79	68	51.2	40.1	34.9
DB-Iso-DP1	143	176	0.97	1.4	1.74
DB-DP1	31	38	0.77	0.23	0.34
DB-Iso-DP2	129	198	1.6	2.1	3.3
DB-DP2	29	44	1.1	0.26	0.40
Dalbavancin (B0)	125	158	39.5	50.9	54.0
Unknown degradants	None detected	None detected	4.9	5.0	5.3
Total degradants	N/A	N/A	60.6	49.1	46.0

^aLevels of degradation products are expressed relative to their levels in acetate buffer without metal ions
^bLevels of degradation products are expressed as the area under their HPLC peak as a percentage of the total peak area