Samples: |
A-1 |
A-2 |
B-1 |
B-2 |
B-3 |
Appearance |
white |
white |
light yellow |
white |
light yellow |
Water |
7.1% |
7.1% |
1.8% |
1.9% |
1.9% |
X-ray powder diffraction1 |
Figure 2 |
TGA2 |
Figure 3 |
Uniformity of mass (RSD) |
2.6% |
2.5% |
2.7% |
2.6% |
3.2% |
Related
substances |
MTT |
0.16% |
0.14% |
0.31% |
0.38% |
0.89% |
Total impurities |
0.41% |
0.46% |
1.31% |
2.37% |
2.50% |
High molecular mass polymers |
0.10% |
0.09% |
0.27% |
0.31% |
1.06% |
Assay3 |
105.7% |
106.3% |
97.2% |
94.4% |
90.8% |
1 Samples A-1, A-2: crystalline form; Samples B-1, B-2, B-3: amorphous form.
2 Samples A-1 and A-2 had similar TGA curves (Figure 3-A) while samples B-1,
B-2, B-3 had similar TGA curves (Figure 3-B).
3 Assay was based on its labeled amount of cefpiramide (1.0 g/ vial). |
