Direct Determination of ECD in ECD Kit: A Solid Sample Quantitation Method for Active Pharmaceutical Ingredient in Drug Product

Table 2

Preparation and composition of ECD calibration standards, blank, and quality control samples.

Sample	WECD^(1) (mg/vial)	WKit^(2) (mg/vial)	WS^(3) (mg/vial)	%WS^(4) (%, w/w)
Kit blank (BkKit)	0.00	25.61	0.00	0.00
ECD Calibration standards
StdECD no. 1	0.78	26.27	0.123	0.47
StdECD no. 2	0.89	26.00	0.140	0.54
StdECD no. 3	0.97	26.10	0.152	0.58
StdECD no. 4	1.07	26.04	0.168	0.65
ECD QC samples (QCECD)
QC-L	0.23	7.27	0.036	0.48
QC-M	0.27	7.23	0.042	0.57
QC-H	0.31	7.19	0.049	0.65

⁽¹⁾Nominal weight of ECD in ECD Kit.
⁽²⁾Total weight of ECD Kit.
⁽³⁾Nominal weight of sulfur in ECD Kit.
⁽⁴⁾Percentage of sulfur (%, w/w) in ECD Kit.