Customization: | Available |
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Powder: | Yes |
Customized: | Non-Customized |
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Product name |
Afatinib |
CAS NO. | 439081-18-2 |
Synonyms |
Afatinib |
Category | Pharmaceutical Raw Materials,Active Pharmaceutical Ingredients,Bulk Drugs,Fine Chemicals. |
Purity | 99% Afatinib |
Appearance | Afatinib characteristic powder |
Shelf life | 2 years |
Usage |
Afatinib is an active pharmaceutical ingredient used for antineoplastics |
Storage |
Afatinib should be stored in a well-closed container at low temperature, keep away from moisture, heat and light. |
Afatinib (INN; trade name Gilotrif in the US and Giotrif in Europe, previously Tomtovok and Tovok) is a drug approved in United States, Europe, Taiwan, Mexico, Chile and Japan as well as other countries for the first-line treatment of patients with distinct types of metastatic (EGFR mutation positive) non-small cell lung carcinoma (NSCLC), developed by Boehringer Ingelheim. It acts as an irreversible covalent inhibitor of thereceptor tyrosine kinases epidermal growth factor receptor (EGFR) and erbB-2 (HER2).
2. Afatinib is not only active against EGFR mutations targeted by first generation TKIs like erlotinib or gefitinib, but also against mutations such as T790M which are not sensitive to these standard therapies.Because of its additional activity against Her2, it is being investigated for breast cancer as well as other EGFR and Her2 driven cancers.
3. Afatinib is a drug for the first-line treatment of patients with distinct types of metastatic (EGFR mutation positive) non-small cell lung carcinoma (NSCLC).It acts as an irreversible covalent inhibitor of the receptor tyrosine kinases epidermal growth factor receptor (EGFR) and erbB-2 (HER2)
Certificate of Analysis
Batch Number | Z20190412001 | ||
Production Date | 2019.04.12 | ||
Batch Quantity | 80 KGS | ||
Item | Test Standard | Testing Result | |
Appearance | Powder | Complies | |
Color | White fine Powder | Complies | |
Particle Size | 100% pass 80 mesh | Complies | |
Oder | Characteristic | Complies | |
Taste | Characteristic | Complies | |
Loss on Drying | ≤5.0% | 2.20% | |
Residue on Ignition | ≤0.1% | 0.05% | |
Residual acetone | ≤0.1% | Complies | |
Residual Ethanol | ≤0.5% | Complies | |
Heave Mentals | ≤10ppm | Complies | |
Na | ≤0.1% | <0.1% | |
Pb | ≤3 ppm | Complies | |
Total Plate | <1000CFU/g | Complies | |
Yeast & Mold | <100 CFU /g | Complies | |
E. Coli | Negative | Complies | |
Salmonella | Negative | Complies | |
Conclusion: Conform with USP Standard |
Storage:Closed container. dry & cool. keep away from moisture &strong light
Shelf life:24 Months
Shipping Options as follows
EMS | Around 7-10 working days |
DHL | Around 3-5 working days |
Fedex | Around 4-6 working days |
TNT | Around 6-7 working days |
By Air | Around 5-7 working days |
By Sea | Around 15-30 working days |
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