Dapagliflozin (INN, USAN, trade name Farxiga far-see-guh in the U.S. and Forxiga in the EU and Russia) is a drug of the gliflozin class, used to treat type 2 diabetes. It was developed by Bristol-Myers Squibb in partnership with AstraZeneca.
Medical uses
In July 2011 a U.S. Food and Drug Administration (FDA) endocrinologic and metabolic drugs advisory committee recommended against approval until more data were available.
The FDA approved dapagliflozin on January 8, 2014 for glycemic control, along with diet and exercise, in adults with type 2 diabetes.
In 2012, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion on the drug. It is now marketed in a number of European countries.
The FDA approved the combination product dapagliflozin and metformin hydrochloride extended-release, called Xigduo XR, in October 2014.
In Feb 2017 the FDA approved a once-daily combination of dapagliflozin 10 mg and saxagliptin 5 mg, as Qtern.
Product Description:
Name: Dapagliflozin
Purity: 99%
Appearance: white Powder
| Product name | Dapagliflozin |
| Synonyms | dapagliflozin propanediol monohydrate |
| CAS No. | 461432-26-8 |
| Molecular formula | C24H35ClO9 |
| Molecular weight | 502.98200 |
| Appearance | White powder |
| Melting point | 202 °C |
| Boiling point | 661.189°C at 760 mmHg |
| Assay | 98%min |
| Packing | 100G/bag,1Kg/bag or as demand |
| Application | APIs |
Specifications:
| Tests | Specifications | Results |
| Appearance | White or off-white powder | White powder |
| Identification: | ||
| A. IR(KBr) | The sample spectrum corresponds to that of the working standard | Confirm |
| B. HPLC | The retention time of the major peak in the chromatogram of the sample corresponds to that exhibited by the working standard | Confirm |
| Single impurity | Not more than 0.1% | 0.08% |
| Total impurities | Not more than 1.0% | 0.5% |
| E.e % | More than 98.5% | 99% |
| Assay (by HPLC) | Not less than 98.0% and not more than 102.0% w/w | 99.1% |
| Conclusion | Comply with In-house standard. | |
| Storage | Store protected from light and moisture | |
Package:
1kg, 2kg, 5kg/Drum or carton with aluminum foil bags inside or small package as customer's requirement;
10kg, 15kg, 25kg/Drum with food grade plastic bag inside.
Storage:
Store in a cool & dry area. Keep Away from strong direct light.
Delivery: Transit could be DHL,UPS,TNT,EMS,Fedex,and so on.
For mass orders, it will be delivered by air or sea. Please allow 5-8 days by Air, 15-30 days by Sea.
For small order, please expect 3-7 days by UPS DHL EMS.
Depending on your location, please allow 1-5 business days for your order to arrive.
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