Ranitidine in Sodium Chloride Injection
» Ranitidine in Sodium Chloride Injection is a sterile solution of Ranitidine Hydrochloride and Sodium Chloride in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amounts of both ranitidine (C13H22N4O3S) and sodium chloride.
Packaging and storage Preserve in glass containers, preferably of Type I or Type II glass, or in containers of suitable plastic, protected from light. Store at a temperature between 2 and 25. Do not freeze.
USP Reference standards 11
USP Ranitidine Related Compound A RS
5-[[(2-Aminoethyl)thio]methyl]-N,N-dimethyl-2-furanmethanamine, hemifumarate salt.
A: The RF value of the principal spot observed in the chromatogram of the Test preparation obtained as directed in the Chromatographic purity test corresponds to that obtained from the Standard preparation.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation as obtained in the Assay.
Bacterial endotoxins 85 It contains not more than 7.0 USP Endotoxin Units per mg of ranitidine.
pH 791: between 6.7 and 7.3.
Test preparation [noteApply a quantity of extractives from Injection to the chromatographic plate to achieve a nominal loading of 200 µg of ranitidine. ] Transfer an accurately measured volume of Injection, equivalent to 10 mg of ranitidine, to a suitable flask, add about 5 times this volume of alcohol, and evaporate to dryness at a temperature not exceeding 30. Redissolve the residue in 1.0 mL of a mixture of methanol and water (50:50).
Standard preparation Dissolve USP Ranitidine Hydrochloride RS in a mixture of methanol and water (50:50) to obtain a Standard preparation having a known concentration of 672 µg (equivalent to 600 µg of ranitidine base) per mL. Dilute portions of this Standard preparation quantitatively, and stepwise if necessary, with the mixture of methanol and water (50:50) to obtain solutions having concentrations of 448 µg per mL (Diluted standard preparation A), 224 µg per mL (Diluted standard preparation B), 112 µg per mL (Diluted standard preparation C), 56 µg per mL (Diluted standard preparation D), and 11 µg per mL (Diluted standard preparation E), respectively.
Resolution preparation Dissolve USP Ranitidine Related Compound A RS in methanol to obtain a solution having a known concentration of 1.27 mg per mL.
Procedure Apply separately 10 µL of the Standard preparation, the Diluted standard preparations (A, B, C, D, and E) and 20 µL (superposition of 2 × 10 µL) of the Test preparation to a suitable thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture. In addition, apply separately a further loading of 10 µL of the Test preparation to the same plate, and on top of this application, apply 10 µL of the Resolution preparation. Allow the spots to dry, and develop the chromatograms in a solvent system consisting of a mixture of ethyl acetate, isopropyl alcohol, ammonium hydroxide, and water (25:15:5:1) until the solvent front has moved not less than 15 cm from the origin. Remove the plate from the developing chamber, mark the solvent front, and allow to air-dry. Expose the plate to iodine vapors in a closed chamber until the chromatogram is fully revealed. Examine the plate and compare the intensities of any secondary spots observed in the chromatogram of the Test preparation with those of the principal spots in the chromatograms of the Standard preparation and Diluted standard preparations (A, B, C, D, and E): the system suitability requirements are met when there is complete resolution between the primary spots of the Test preparation and the Resolution preparation and if a spot is observed in the chromatogram of Diluted standard preparation E. The major secondary spot is not greater in size or in intensity than the principal spot produced by the Standard preparation (3.0%), and no other secondary spot is greater in size or intensity than the principal spot produced by Diluted standard preparation A (2.0%). The sum of the intensities of all secondary spots obtained from the Test preparation corresponds to not more than 6.0%.
Other requirements It meets the requirements under Injections 1.
Assay for ranitidine
Mobile phase, Standard preparation, System suitability solution, and Chromatographic system Prepare as directed in the Assay under Ranitidine Injection.
Assay preparation Dilute an accurately measured volume of Injection, quantitatively and stepwise if necessary, with Mobile phase to obtain a solution having a concentration of 0.1 mg of ranitidine per mL.
Procedure Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the area responses for the major peaks. Calculate the quantity, in mg, of C13H22N4O3S in the portion of Injection taken by the formula:
(314.40 / 350.87)(L / D)(C)(rU / rS)in which 314.40 and 350.87 are the molecular weights of ranitidine and ranitidine hydrochloride, respectively; L is the labeled quantity of ranitidine in the Injection taken; D is the concentration, in mg per mL, of ranitidine in the Assay preparation, on the basis of the labeled quantity and the extent of dilution; C is the concentration, in mg per mL, of USP Ranitidine Hydrochloride RS in the Standard preparation and rU and rS are the peak area responses obtained from the Assay preparation and the Standard preparation, respectively.
Assay for sodium chloride Dilute an accurately measured volume of Injection, quantitatively and stepwise if necessary, with water to obtain a suitable volume of a solution having a concentration of about 0.5 mg of sodium chloride per mL. Titrate with 0.1 N silver nitrate VS using a silver-silver chloride electrode. Each mL of 0.1 N silver nitrate is equivalent to 3.545 mg of chloride. From the determined concentration per mL, subtract the quantity (35.453/314.40)W so as to correct for the chloride present as ranitidine hydrochloride where W is the quantity, in mg per mL, of ranitidine as determined in the Assay for ranitidine. Multiplication of the answer by 1.648 gives the amount of sodium chloride per mL.
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