Ceftaroline Fosamil

Physical and Quality Control Parameters

Appearance: White to off-white crystalline powder, odorless, hygroscopic; the sodium salt form is more hygroscopic and requires vacuum-sealed packaging.

Solubility

The sodium salt is very soluble in water (solubility > 80 mg/mL, 25℃), slightly soluble in methanol, and practically insoluble in ethanol and acetone;

The aqueous solution is clear, with a pH range of 4.5-6.5, suitable for the preparation of intravenous injections, and shows no significant precipitation after reconstitution.

Stability

The solid form should be stored sealed, protected from light, and refrigerated at 2-8℃, with a shelf life of 24 months; it is easily degraded after moisture absorption and requires aluminum-plastic composite film packaging to avoid contact with moisture.

The reconstituted solution is stable for 6 hours at room temperature and 24 hours when refrigerated at 2-8℃; avoid mixing with solutions containing metal ions (such as Ca²⁺, Mg²⁺) to prevent the formation of insoluble precipitates.

Key Quality Control Indicators (API level, sodium salt)

Chemical Purity: ≥99.0% (HPLC area normalization method, detection wavelength 254 nm)

Related Substances: Single impurity ≤0.1%, total impurities ≤0.5% (HPLC impurity comparison method)

Moisture Content: ≤2.0% (Karl Fischer method)

Phosphorus Content: 5.4%-5.8% (Molybdenum blue colorimetric method)

Sodium Content: 3.8%-4.2% (Atomic absorption spectrophotometry)

Sterility: Complies with the requirements of the Chinese Pharmacopoeia sterility test method

Bacterial Endotoxin: ≤0.1 EU/mg