Table 2.
Summary of results for U.S. marketplace vancomycin samples
| Parameter | Vancomycin assay result |
||||||
|---|---|---|---|---|---|---|---|
| USP | Hospira | Bioniche | Akorn Strides | APP Pharma | Sandoz | Baxter | |
| Vancomycin B assay value (%, wt/wt)a | NDc | 100.8 | 111.4 | 109.8 | 107.0 | 109.9 | 94.9 |
| CDP-1 total (%, wt/wt) | ND | 0.48 | 0.20 | 0.25 | 0.15 | 1.21 | 0.06 |
| Largest impurity | Unknown | VM B isomer | VM B isomer | VM B isomer | VM B − Me | VM B isomer | Unknown |
| m/z of largest impurity (z = 2) | 723.71266 | 724.72104 | 724.72104 | 724.72104 | 717.71280 | 724.72104 | 723.71266 |
| Total impurities (area %)b | 5.43 | 9.37 | 4.79 | 5.15 | 5.03 | 4.68 | 5.53 |
| CDP-1 total (area %)b | 0.05 | 0.28 | 0.19 | 0.16 | 0.19 | 0.40 | 0.09 |
| Largest impurity (area %)b | 1.23 | 1.03 | 0.97 | 0.95 | 1.12 | 0.95 | 1.24 |
| Area % of VM Bb | 94.6 | 90.6 | 95.2 | 94.9 | 95.0 | 95.3 | 94.5 |
a
When assayed quantitatively against a USP standard.
b
Normalized area percent.
c
ND, not determined.