Dihydroergotamine Mesylate Injection
» Dihydroergotamine Mesylate Injection is a sterile solution of Dihydroergotamine Mesylate in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C33H37N5O5·CH4O3S.
Packaging and storage Preserve in single-dose containers, preferably of Type I glass, protected from light.
USP Reference standards 11
USP Endotoxin RS
Identification Dilute 2 mL of Injection with water to 25 mL: the UV absorption spectrum of the solution so obtained exhibits maxima and minima at the same wavelengths as that of a similar solution of USP Dihydroergotamine Mesylate RS, concomitantly measured.
Bacterial endotoxins 85 It contains not more than 175.0 USP Endotoxin Units per mg of dihydroergotamine mesylate.
pH 791: between 3.4 and 4.9.
Other requirements It meets the requirements under Injections 1.
Reagent preparation Dissolve 250 mg of p-dimethylaminobenzaldehyde in a cooled mixture of 130 mL of sulfuric acid and 70 mL of water, and add 0.40 mL of ferric chloride solution (1 in 20).
Standard preparation Dissolve in tartaric acid solution (1 in 100) a suitable quantity of USP Dihydroergotamine Mesylate RS, accurately weighed, and dilute quantitatively and stepwise with the same solvent to obtain a solution having a known concentration of about 50 µg per mL.
Assay preparation Transfer an accurately measured volume of Injection, equivalent to about 5 mg of dihydroergotamine mesylate, to a 100-mL volumetric flask, dilute with tartaric acid solution (1 in 100) to volume, and mix.
Procedure Transfer 5.0 mL each of the Standard preparation, the Assay preparation, and tartaric acid solution (1 in 100) to provide the blank, to separate 50-mL conical flasks. Add 10.0 mL of the Reagent preparation to each, shake, and allow to stand for 30 minutes. Concomitantly determine the absorbances of the solutions in 1-cm cells at the wavelength of maximum absorbance at about 585 nm, with a suitable spectrophotometer, using the blank to set the instrument. Calculate the quantity, in mg, of C33H37N5O5·CH4O3S in each mL of the Injection taken by the formula:
(0.1C / V)(AU / AS)in which C is the concentration, in µg per mL, of USP Dihydroergotamine Mesylate RS in the Standard preparation, V is the volume, in mL, of Injection taken, and AU and AS are the absorbances of the solutions from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 2909