Procaine Hydrochloride Injection
» Procaine Hydrochloride Injection is a sterile solution of Procaine 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 C13H20N2O2·HCl.
Packaging and storage Preserve in single-dose or in multiple-dose containers, preferably of Type I or Type II glass. The Injection may be packaged in 100-mL multiple-dose containers.
USP Reference standards 11
USP Endotoxin RS
Identification Evaporate a portion of Injection, equivalent to about 20 mg of procaine hydrochloride, on a steam bath just to dryness, and dry over silica gel for 18 hours: the residue responds to Identification tests A and B under Procaine Hydrochloride.
Bacterial endotoxins 85 It contains not more than 0.6 USP Endotoxin Unit per mg of procaine hydrochloride.
pH 791: between 3.0 and 5.5.
Particulate matter 788: meets the requirements under Small-volume injections.
Other requirements It meets the requirements under Injections 1.
Standard preparation Transfer to a 125-mL separator about 50 mg, accurately weighed, of USP Procaine Hydrochloride RS, and dilute with water to 20 mL.
Assay preparation Transfer to a 125-mL separator an accurately measured volume of Injection, equivalent to about 50 mg of procaine hydrochloride, and dilute with water to 20 mL.
Procedure To the Standard preparation and also to the Assay preparation add 5 mL of 6 N ammonium hydroxide, then treat each as follows. Extract with five 25-mL portions of chloroform, and filter the combined extracts through about 1 g of anhydrous sodium sulfate supported on a pledget of glass wool. Receive the filtrate in a 200-mL volumetric flask, add chloroform to volume, and mix. Transfer 3.0 mL of this solution to a 100-mL volumetric flask, add chloroform to volume, and mix. Concomitantly determine the absorbances of both solutions at the wavelength of maximum absorbance at about 280 nm, with a suitable spectrophotometer, using chloroform as the blank. Calculate the quantity, in mg, of C13H20N2O2·HCl in each mL of the Injection taken by the formula:
(W / V)(AU / AS)in which W is the weight, in mg, of USP Procaine Hydrochloride RS used, 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 4425