[character] the product is a white paste.
[identification]
[check] water to take this product, with anhydrous methanol chloroform (30:70) as solvent, as moisture determination method (Appendix 58 pages, the first method) determination
Water, containing not more than 2%.
Extrusion experiment to take this product 5, the content should be easy out, must not be blocked.
Sterile take this product, add 45 DEG C sterile isopropyl myristate, 300ml, blending, 10ml, and penicillin enzyme 2000
Million units, shake, at a temperature of 37 DEG C placed 30 minutes, to check (Appendix 76 pages), shall comply with the provisions of.
Installed capacity to take this product in 5 branches, each branch of squeezing out content weight should be 4.5 ~ 4.7g.
[] according to the content determination by high performance liquid chromatography (Appendix 24 pages) determination.
Chromatographic conditions and test system for eighteen alkyl silane bonded silica as filler; potassium dihydrogen phosphate solution
Methanol (1:1) as mobile phase, adjusted to pH 5 with phosphoric acid; the detection wavelength was 230nm. According to the number of board chlorazol West
Raymond Lam calculation should not be lower than 1500 degrees of separation of ampicillin and cloxacillin in West Raymond Lam shall conform to the requirements.
Determination of fetching content, volume under stirring, about 1.5g, accurately weighed, the centrifugal tube, joined by ampicillin
Ampicillin and Cloxacillin saturated with petroleum ether (boiling range of 30 DEG to 60 DEG) 20ml, mixing, centrifugal, discard supernatant; with the same method
The operation of a; adding mixed with ampicillin and Cloxacillin saturated ether 20ml
China (Mainland)
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