Sun Pharmaceutical Industries Limited

Pharmaceutical Industries Limited

Bhaskar Pallerla

Rajamannar Thennati

Subhas Balaram Bhowmick

Sudeep Kumar Agrawal

Alpesh Goyani

Deepak Singodia

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&#xb0; C. and 60% relative humidity for at least three months.

Parenteral unit dosage form of dihydroergotamine

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&#xb0; C. and 60% relative humidity for at least three months. 

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Baroda, India

Bhaskar Pallerla