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Parenteral unit dosage form of dihydroergotamine
专利权人:
SUN PHARMACEUTICAL INDUSTRIES LIMITED
发明人:
Alpesh Goyani,Deepak Singodia,Bhaskar Pallerla,Sudeep Kumar Agrawal,Subhas Balaram Bhowmick,Rajamannar Thennati
申请号:
US16285495
公开号:
US10532049B1
申请日:
2019.02.26
申请国别(地区):
US
年份:
2020
代理人:
摘要:
A parenteral unit dosage form comprising an aqueous solution of dihydroergotamine or pharmaceutically acceptable salt thereof as a sole active ingredient, one or more pH adjusting agents, and optionally one or more co-solvents, wherein the pH of the aqueous solution is such that it contains substantially lower amount of impurity of Formula I and impurity of Formula II as compared to aqueous solution having a pH of 4.0 or less, when the parenteral unit dosage form is stored at 25° C. and 60% relative humidity for at least three months.
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