Table 1.

Characteristics, pH, Titratable Alkalinity, Turbidity Point, and Molecular Weight of the Six Asian ISS Preparations Compared with the Originator Iron Sucrose (IS_ORIG) and the Pharmacopeia (USP). (Studies Performed by the Quality Control Laboratory of Vifor (International), St. Gallen, Switzerland)

Parameter	USPa	ISORIG	ISSFERP	ISSFERI	ISSFERO	ISSENCI	ISSENCI	ISSBACK	ISSBACK	ISSLIB
Lot	-	517100	H3797	024-T	6016	LHA04003	LHA05005	F5097	D5064	A5015
Characteristics	-	Dark brown, opaque aqueous solution	Complies	Complies	Complies	Complies	Complies	Complies	Complies	Complies
pH	10.5-11.1	10.9	10.5	10.4	9.8	10.6	10.8	10.8	10.5	10.6
Titratable alkalinity (ml)	0.5-0.8	0.8	0.55	0.4	0.18	0.33	0.4	0.46	0.38	0.37
Turbidity point	4.4-5.3	4.9	5.1	9.7	4.2	5.8	6.4	N/Ab	N/Ab	5.33
Mw (Da)	34,000-60,000	45,700	50,600	215,000	39,200	50,500	46,400	293,000	162,000	246,000
Mn (Da)	≥24,000	33,900	36,100	85,200	31,300	35,100	34,200	175,000	93,300	151,000
P	≤1.7	1.3	1.4	2.52	1.25	1.44	1.36	1.67	1.74	1.63

^a[27]

^bStarting solution turbid

N/A, not available; Mw (Da), weight average molecular weight in Dalton; Mn (Da), number average molecular weight in Dalton; P = ratio Mw/Mn