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| Ifosfamide sterile |
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| Ifosfamide |
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| Antineoplastics |
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Appearance: White or almost white,fine,crystalline power White,fine,crystalline power
Identification:
IR absorption: Sample exhibits maximal only at the same wavelengths
as ifosfamide reference spectrum Conforms Appearance of solution: Clear and ≤Y7 Conforms
Acidity or alkalinity: Not more than 0.1ml of 0.01M
Hydrochloric acid solution R is added Conforms
Not more than 0.3ml of 0.01M sodium
Hydroxide solution R is added
PH of 10% solution should between 4.0-7.0 5.1
Specific optical rotataion: -0.10°to +0.10° 0°
Related substances(TLC):
a.)Impurity A.C.E.F ≤0.25% Conforms
b)Impurity B: ≤0.15% Conforms
d)All other impurities: ≤0.15% Conforms
Chlorides(Ionic chloride): ≤100ppm Conforms
Chloroform-insoluble phosphorus: ≤415ppm Conforms
Heavy metals: ≤10ppm Conforms
Water: ≤0.3% 0.0%
Bacterial endotoxins: Not more than 0.125E.U.per mg Conforms
Sterility test(by membrane filtration method): Meet the requirements Conforms
Residual solvents:
a) Ethanol ≤0.1% 0.03%
b)Ethyl ether: ≤0.05% 0.01%
c)Tetrahydrofuran ≤0.05% 0.01%
Organic volatile impurities:
a) Chloroform ≤0.005% 0.003%
b)Methylene chloride: ≤0.01% 0.002%
Assay(HPLC):
Ifosfamide: 98.0%-102.0% 100.8%
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