High-Purity Pemetrexed Disodium Powder/Apis
China High-Purity Pemetrexed Disodium Powder/Apis, Find details about China Pemetrexed, Disodium from High-Purity Pemetrexed Disodium Powder/Apis
Basic Info.
Heavy Metal
Nmt 20ppm
Trademark
Simcere Pharmaceutical
Transport Package
1kg/Aluminum Bottle
Origin
China
Heavy Metal
Nmt 20ppm
Trademark
Simcere Pharmaceutical
Transport Package
1kg/Aluminum Bottle
Origin
China
Product Desciption
Product Application
1. Pemetrexed disodium (marketed as ALIMTA®, "pemetrexed") is a novel, multi-targeted antifolate. It suppresses tumor growth by impeding both DNA synthesis and folate metabolism. Pemetrexed disodium has demonstrated promising clinical activity in a wide variety of solid tumors, including non-small cell lung, breast, mesothelioma, colorectal, pancreatic, gastric, bladder, cervix, and head and neck.
2. Pemetrexed disodium is approved to be used alone or with other drugs to treat malignant pleural mesothelioma in patients who cannot be treated with surgery and non-small cell lung cancer (certain types) in patients whose disease is locally advanced or has metastasized (spread to other parts of the body). Pemetrexed disodium is also being studied in the treatment of other types of cancer.
Specifications
Qualifications
1. Pemetrexed disodium (marketed as ALIMTA®, "pemetrexed") is a novel, multi-targeted antifolate. It suppresses tumor growth by impeding both DNA synthesis and folate metabolism. Pemetrexed disodium has demonstrated promising clinical activity in a wide variety of solid tumors, including non-small cell lung, breast, mesothelioma, colorectal, pancreatic, gastric, bladder, cervix, and head and neck.
2. Pemetrexed disodium is approved to be used alone or with other drugs to treat malignant pleural mesothelioma in patients who cannot be treated with surgery and non-small cell lung cancer (certain types) in patients whose disease is locally advanced or has metastasized (spread to other parts of the body). Pemetrexed disodium is also being studied in the treatment of other types of cancer.
Specifications
| Item | Specifications | ||
| Appearance | White to slightly yellow powder; Freely soluble in water, 0.1mol/L NaOH; slightly soluble in 0.1mol/L HCl; practically insoluble in chloroform. | ||
| Specific optical rotation | +10.0°~ +13.0° | ||
| PH | 7.5~8.4 | ||
| Water | 7.8%~9.6% | ||
| Heavy Metals | NMT 20 ppm | ||
| Chloride | NMT 0.05% | ||
| Ethyl p-toluenesulfonate | NMT 60 ppm | ||
| Impurity A | NMT 0.15% | ||
| Impurity D | NMT 0.15% | ||
| Other Individual Impurity | NMT 0.1% | ||
| Total Impurities | NMT 0.6% | ||
| Enantiomer (Impurity E) | NMT 0.3% | ||
| Ethanol | NMT 0.5% | ||
| Acetone | NMT 0.5% | ||
| Dichlomethane | NMT 0.06% | ||
| DMF | NMT 0.088% | ||
| DMSO | NMT 0.5% | ||
| TAMC | NMT 103 cfu/g | ||
| TYMC | NMT 102 cfu/g | ||
| E. coli. | Should be Absent per g | ||
| Alive Mite | Should be Absent | ||
| Assay | 98.5% ~ 102.0% of Pemetrexed Disodium (C20H19N5O6Na2), calculated on the anhydrous basis |
Qualifications
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