Table 3.

Purity, Identity and Quality of X07091 = NVP-13.

Molecular Formula (Sodium Salt)	C164H183O83N64S15P15Na15
Molecular weight	5365.3 Da (free acid) / 5693.94 Da (sodium salt)
Description	White to off-white powder, odourless
Stereochemistry	NVP-13 is a mixture of 215 stereoisomers
Hygroscopicity	The drug substance is hygroscopic
Crystalline form	Amorphous
pH	The pH value of a 5 mg/mL solution of NVP-13 in - aCSF is approximately 7.1 - water for injection (WfI) is approximately 7.2, - isotonic sterile saline (0.9% NaCl) is approx. 6.5.
Solubility	The compound is a sodium salt that is soluble in aqueous solution. The solubility is ≥ 30 mg/mL