TABLE 1.
Percentages of vancomycin factor B (purity) and impurities in six of the vancomycin products licensed for parenteral use in the United States measured by the FDA by HPLCa
| VAN product | Manufacturer | Lot no. | % |
||
|---|---|---|---|---|---|
| VAN factor B | Total impurities | Largest impurity | |||
| A | Mylan, Inc.b | 12L37772A | 92.5 | 7.5 | 2.1 |
| B | Hospira, Inc. | 204628E04 | 92.9 | 7.1 | 1.1 |
| C | Pfizer, Inc.c | 7601646 | 91.6 | 8.4 | 1.2 |
| D | APP Pharmaceutics, LLC | 6105175 | 92.2 | 7.8 | 2.2 |
| E | Sandoz, Inc. | BU6345 | 92.5 | 7.5 | 1.5 |
| F | Baxter Healthcare Corp. | 2G3552/NC077974 | 94.6 | 5.4 | 2.4 |
a
The data for the vancomycin (VAN) products were provided blinded (labeled products A through F) by the FDA to the University of Florida researchers. The names of the manufacturers of the vancomycin products were provided to the University of Florida researchers only after the experiments and analysis of the data were completed and the first draft of the manuscript was written.
b
Mylan, Inc., purchased Bioniche Pharma USA, LLC.
c
Pfizer, Inc., purchased Akorn Strides, LLC.