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Ifosfamide
[ SYNONYMS ] : 3-(2-Chloroethyl)-2-[(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide, A-4942, Asta-Z-4942, Cyfos, Holoxan, Holoxan 1000, Ifex, Ifosfamid, Ifosfamide, Iphosphamid, Isoendoxan, Isofosfamide, Isophosphamide, Mitoxana, MJF-9325, Naxamide, NSC-109724, Z-4942, Z4942
[CAS Number ] : 3778-73-2
[ SPECIFICATION: ] :
USP23, see the COA.
Certificate of Analysis
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| Batch No. 000302 |
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Mfg. Date: 2000/03 |
| Quantity: 1kg |
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Exp. Date: 2002/03 |
| Appearance: |
White to off-white crystalline powder;No visible evidence of contamination by foreign matter. |
conforms |
| Identification A |
IR spectrum exhibits maxima only at the same wavelenghts as that of similar preparation of the USP reference standard |
conforms |
| Identification B |
Retention time of the sample corresponds to the retention time of the reference standard by HPLC |
conforms |
| PH |
4.0--7.0 |
5.1 |
| Water content; |
Not more than 0.3% |
0.1% |
| Heavy metals: |
Not more than 0.002% |
less than 0.002% |
| Ionic chloride |
Not more than 0.018% |
less than 0.018% |
| Chloroform-insoluble Phosphorus |
Not more than 0.0415% |
0.0077% |
| 2-chloroethylamine hydrochloride |
Not more than 0.25% |
less than 0.25% |
| Assay: |
98.0%--102.0% |
98.9% |
| Residual Solvents |
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Ethanol
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NMT 0.1% |
less than 0.1% |
Ethyl ether
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NMT 0.05% |
less than 0.05% |
THF
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NMT 0.05% |
less than 0.05% |
| Organic Volatile Impurities |
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Chloroform
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NMT 0.005% |
less than 0.005% |
Methylene Chloride
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NMT 0.01% |
less than 0.01% |
| Bacterial Endotoxins |
NMT 0.125EU/mg |
less than 0.125EU/mg |
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