High Quality Neratinib CAS NO.698387-09-6

 Qingdao Sigma Chemical Ltd is is a global chemical industry manufacturers and suppliers of pharmaceuticals and intermediates, peptide,Nootropis etc API, food and feed additives, herbal extracts, agrochemicals and fine chemicals etc.

 

Our Laboratory is located in shandong province. There are 15 experts in our research team. Talented personnel and well-equipped laboratory makes rigorous and professional quality control possible. Lyphar Biotech is equipped with various detection devices, such as HPLC, GC, Spectrophotometer, AAS, Polarimeter, Auto titrators, BOD Incubators, COD Incubators, Melting point apparatus and so on.

 

The aim of QDSIGMA is a quality policy that "Elements in the system all have been satisfied, Personnel has been trained; Every batch of material is checked, Each procedure guarantees the quality; Every bag of our products is top grade, Service is thoughtful all the time, quality and reputation to increase market share and promote enterprise development. The quality, colors and forms of our products have reached a high level in related chemical industry, which relies on characteristic and advanced processing technology and it has gained a high and reliable reputation from customers at both quality and services.

 

QDSIGMA has become the "Top 500 Chinese manufacturing companies","Top 20 of global chemical sales".QDSIGMA has 21 subsidiaries and holding companies.

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.

Function

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