Cloxacillin Sodium
powder, oral
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Application
Quality used for the manufacture of oral dosage forms such as granules for suspension, tablets, and film-coated tablets.
Antibiotic category
Semisynthetic penicillin for oral use
Packaging
Storage
Store below 25°C,
Protect from light and moisture
Shelf life
60 months
Specification
| Appearance | white or almost white, crystalline powder |
|---|---|
| Solubility | freely soluble in water |
| Specific optical rotation | +160° to +169° 1) |
| Absorbance (430nm; Ph.Eur.) | not more than 0.040 |
| Bulk density | 0.40 g/ml - 0.59 g/ml |
| Tapped density | informative g/ml |
| Water content (Karl Fischer) | 3.0 - 4.5 % |
| Clarity of solution ( Ph.Eur.) | clear |
| pH-value | 5.0 - 7.0 |
| 2-Ethylhexanoic acid | not more than 0.5 % |
| Related substances (HPLC) | individual: not more than 1.0 % total: not more than 5.0% |
| Assay | Cloxacillin Sodium (HPLC): 95.0 - 102.0 % 1) 950 - 1020 µg/mg 1) |
1) Based on the anhydrous substance
Remark
N,N-Dimethylaniline and dichloromethane are not used in the manufacturing process
Pharmacopoeial quality
USP, BP, Ph.Eur.
