Tolazoline Hydrochloride Injection
» Tolazoline Hydrochloride Injection is a sterile solution of Tolazoline Hydrochloride in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C10H12N2·HCl.
Packaging and storage Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.
USP Reference standards 11
USP Endotoxin RS
A: Infrared Absorption 197KObtain the test specimen as follows. Steam-distill a volume of Injection, equivalent to about 250 mg of tolazoline hydrochloride, for 5 to 10 minutes, and discard the distillate. Transfer the remaining solution to a separator, add about 2 mL of 1 N sodium hydroxide, and extract with 20 mL of ether. Filter the ether extract through cotton into a beaker, evaporate to dryness, and dry the residue in vacuum over silica gel for 4 hours.
B: It responds to Identification test B under Tolazoline Hydrochloride.
C: To 1 mL of Injection add 1 mL of ammonium reineckate TS: a pink precipitate is formed.
Bacterial endotoxins 85 It contains not more than 0.8 USP Endotoxin Unit per mg of tolazoline hydrochloride.
pH 791: between 3.0 and 4.0.
Other requirements It meets the requirements under Injections 1.
Standard preparation Transfer about 30 mg of USP Tolazoline Hydrochloride RS, accurately weighed, to a 100-mL volumetric flask, dissolve in and dilute with methanol to volume, and mix.
Assay preparation Transfer an accurately measured volume of Injection, equivalent to about 150 mg of tolazoline hydrochloride, to a 100-mL volumetric flask, dilute with methanol to volume, and mix. Transfer 20.0 mL of this solution to a second 100-mL volumetric flask, dilute with methanol to volume, and mix.
Procedure Transfer 3.0 mL each of the Standard preparation, the Assay preparation, and methanol to provide the blank, to separate 25-mL volumetric flasks. To each flask add 1 mL of 0.5 N sodium hydroxide and 1 mL of dilute sodium nitroferricyanide TS (1 in 2), mix, and allow to stand for 10 minutes. Add 3 mL of sodium bicarbonate solution (1 in 12) to each flask, dilute with water to volume, mix, and allow to stand for 10 minutes. Concomitantly determine the absorbances of the solutions in 1-cm cells at the wavelength of maximum absorbance at about 565 nm, with a suitable spectrophotometer, against the blank. Calculate the quantity, in mg, of C10H12N2·HCl in each mL of the Injection taken by the formula:
(0.5C / V)(AU / AS)in which C is the concentration, in µg per mL, of USP Tolazoline Hydrochloride 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 4890