Table 4 Number of injections tested for purity by the Formulation WG
API | Formulation | Strength | Products | Method |
|---|---|---|---|---|
Cefazolin sodium | Injection/sterile powders for injection | 1Â g/vial | 5 | JP (formulation) |
Cisplatin | Injection/solutions | 10Â mg/vial | 6 | JP (API), EP, Approval documentation |
Elcatonin injection | Injection/solutions | 10 elcatonin/1Â mL/vial | 13 | JP (API) |
Famotidine | Injection/sterile powders for injection | 20Â mg/vial | 6 | JP (formulation) |
Injection/solutions | 20Â mg/vial | 1 | Approval documentation | |
Iopamidol | Injection/solutions | 61.24Â % 50Â mL/vial | 4 | JP (API) |
Minocycline hydrochloride for injection | Injection/sterile powders for injection | 100Â mg/vial | 6 | JP (formulation) |
Nafamostat mesilate | Injection/sterile powders for injection | 10Â mg/vial | 15 | Approval documentation |
Nicardipine hydrochloride | Injection/solutions | 10Â mg/vial | 7 | JP (formulation) |
Ozagrel sodium | Injection/sterile powders for injection | 20Â mg/vial | 11 | JP (formulation) |
Injection/solutions | 20Â mg/vial, 80Â mg/vial | 5 | Approval documentation | |
Piperacillin sodium | Injection/sterile powders for injection | 1Â g/vial | 7 | JP (formulation) |
Ritodrine hydrochloride | Injection/solutions | 50Â mg/vial | 10 | JP (API) |
Sulbactam sodium/Ampicillin sodium | Injection/sterile powders for injection | 1.5Â g/vial | 9 | Approval documentation |
Vancomycin hydrochloride | Injection/sterile powders for injection | 0.5Â g/vial | 8 | JP (formulation) |
Total | 13 formulations | Â | 113 products | Â |