698387-09-6 Neratinib Neratinib Price
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Introduction
[English Name] Neratinib
[CAS No.] 698387-09-6
[Mol. Formula ] C30H29ClN6O3
[Storage] Stored in a clean, cool and dry area; keep away from strong, direct light.
[Packaging]100 grams, 500 grams, 1kg, 5 kgs or according to customer's requiement
[Delivery] 2 working days after payment.
Transit could be DHL,UPS,TNT,EMS,Fedex,and so on.
Neratinib was discovered and initially developed by Wyeth; Pfizer continued development up to Phase III in breast cancer, and licensed it to Puma Biotechnology in 2011.
In September 2016 Puma submitted a new drug application to the US FDA for neratinib as a treatment for some people with HER-2 positive breast cancer.
In July 2017 it was approved by the US FDA for adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, (after adjuvant trastuzumab-based therapy).
In January 2018 an EMA committee gave a negative review to neratinib.
Application
Neratinib is used as an adjuvant therapy in people with early stage breast cancer in which HER2 is overexpressed, after the person receives treatment with trastuzumab.
People should be given drugs to prevent diarrhea when they are given neratinib.
Women who are pregnant should not take it, and women should not become pregnant while taking it, and women who are breast-feeding should not use it, as it causes fetal harm.
Specification
Test Item |
Analysis Specification |
Result |
Description |
crystalline powder |
Conforms |
Melting range |
129°C~132°C |
130.8°C-131°C |
Loss on drying |
≤0.5% |
0.20 % |
Specific rotation |
-58°~-62°(C=1,in CH3OH) |
-61.05° |
Sulphated ash |
≤0.1% |
0.08 % |
Heavy metals |
≤10ppm |
Conforms |
Chlorides |
≤0.02% |
Conforms |
Sulfates |
≤0.02% |
Conforms |
Fluorine |
14.7%~17.9% |
15.2% |
Residual solvent |
Methanol ≤0.2% Isopropanol ≤0.2% Ethyl acetate≤0.2% Chloroform ≤0.2% |
0.0% 0.0% 0.0% 0.0% |
Related substances (HPLC) |
Single impurity ≤0.2% Total impurities ≤0.5% |
0.05% 0.08% |
Assay |
≥99.5% |
99.92% |
Conclusion |
Accordance with the reference |
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