Ampicillin Sodium and Sulbactam Sodium Mixture Ratio 2:1 for Injection

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Ampicillin Sodium and Sulbactam Sodium Mixture 2:1 for Injection

Product Name: Ampicillin Sodium and Sulbactam Sodium Mixture 2:1 for Injection

Synonyms: Ampicillin Sodium and Sulbactam Sodium

Characteristics: White powder.

Assay and Potency:

Ampicillin ≥563ug/mg

Subactam ≥280ug/mg

Package: 6KG/TIN; 2TINS/CTN

COA—Ampicillin Sodium and Sulbactam Sodium Mixture 2:1 for Injection

Name of Product	Ampicilline Sodium and Sulbactam Sodium (2:1) for Injection
Testing Item	Standard	Result
Appearance	White powder.	A white powder
Identification	The retention times of the major peaks in the chromatogram of the Assay preparation correspond to those in the chromatogram of the Standard preparation, as obtained in the Assay.	Complies
pH	8.0 ~ 10.0	8.7
Water	≤ 2.0%	0.2%
Visible Particles	Conforms	Conforms
Crystallinity	Conforms	Conforms
Paticulate matter	≥10 μm ≤ 6000 particle/g ≥25 μm ≤ 600 particle/g	356 particle/g 0 particle/g
Bacterial Endotoxins	≤ 0.17EU/mg	0.08EU/mg
Sterility	Should meet the requirement	Complies
Methylene Chloride	≤ 600ppm	425ppm
Ethanol	≤ 5000ppm	992ppm
Assay	Ampicillin ≥563ug/mg Sulbactam ≥280ug/mg	589ug/mg 300ug/mg

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