Table 3.
Source | Lot no. | Sample details | Method (calculations based on area %) |
|||||||
---|---|---|---|---|---|---|---|---|---|---|
BP-HPLC |
OTR-UPLC |
|||||||||
% vancomycin B | % total impurities | % largest impurity | % CDP-1 (maximum amt) | % vancomycin B | % total impurities | % largest impurity | % CDP-1 (maximum amt) | |||
Sandoz Incorporated | AY1780 | 1-g vial | 93 | 7 | 1.4 | 1.8 | 94 | 6 | 1.5 | 1.1 |
Baxter Health Care Corporation | NC063966 | 1-g intravenous bag | 92 | 8 | 1.7 | 0.3 | ||||
2G3552 | 200-ml intravenous bag | 95 | 5 | 2.0 | 0.6 | |||||
Hospira Inc. | 923103A | 1-g vial | 90 | 10 | 0.5 | 1.4 | 89 | 11 | 1.7 | 0.5 |
APP Pharmaceuticals LLC | 6100850 | 1-g vial | 94 | 6 | 1.9 | 1.2 | ||||
6100475 | 93 | 7 | 1.5 | None detected | ||||||
Bioniche Pharma USA LLC | 10F13112A | 1-g vial | 93 | 7 | 1.6 | 0.2 | ||||
10H18782A | 94 | 6 | 1.2 | 2.0 | ||||||
Akorn Strides, LLC | 7004195 | 1-g vial | 91 | 9 | 2.0 | 0.6 | ||||
7004471 | 94 | 6 | 1.1 | 1.9 |