Cephalothin for Injection
» Cephalothin for Injection contains an amount of Cephalothin Sodium equivalent to not less than 90.0 percent and not more than 115.0 percent of the labeled amount of cephalothin (C16H16N2O6S2). It may contain Sodium Bicarbonate.
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Specific rotation 781S: between +124 and +134, calculated on the dried and sodium bicarbonate-free basis.
Test solution: a known amount of specimen, equivalent to about 50 mg of cephalothin, per mL, in water.
Bacterial endotoxins 85 It contains not more than 0.13 USP Endotoxin Unit per mg of cephalothin.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Uniformity of dosage units 905: meets the requirements.
Procedure for content uniformity Perform the Assay on individual containers using Assay preparation 1 or Assay preparation 2, or both, as appropriate.
pH 791: between 6.0 and 8.5, in the solution constituted as directed in the labeling.
Particulate matter 788: meets the requirements for small-volume injections.
Content of sodium bicarbonate (if present) Dissolve about 1 g of it, accurately weighed, in 50 mL of water. Add methyl orange TS, and titrate with 0.1 N sulfuric acid VS. Each mL of 0.1 N sulfuric acid is equivalent to 8.401 mg of NaHCO3. Calculate the percentage of sodium bicarbonate, and use the value obtained to calculate the Specific rotation on the dried and sodium bicarbonate-free basis.
Other requirements It meets the requirements for Identification test A and Loss on drying under Cephalothin Sodium. It meets also the requirements for Labeling under Injections 1.
Mobile phase , Resolution solution, and Chromatographic systemProceed as directed in the Assay under Cephalothin Sodium.
Standard preparation Dissolve a suitable quantity of USP Cephalothin Sodium RS, accurately weighed, in Mobile phase to obtain a solution having a known concentration of about 1 mg of cephalothin per mL.
Assay preparation 1 (where it is represented as being in a single-dose container)Constitute Cephalothin for Injection in a volume of water, accurately measured, corresponding to the volume of solvent specified in the labeling. Withdraw all of the withdrawable contents, using a suitable hypodermic needle and syringe, and dilute quantitatively with Mobile phase to obtain a solution having a concentration of about 1 mg of cephalothin per mL.
Assay preparation 2 (where the label states the quantity of cephalothin in a given volume of constituted solution)Constitute 1 container of Cephalothin for Injection in a volume of water, accurately measured, corresponding to the volume of solvent specified in the labeling. Dilute an accurately measured portion of the constituted solution quantitatively with Mobile phase to obtain a solution having a concentration of about 1 mg of cephalothin per mL.
Procedure Proceed as directed in the Assay under Cephalothin Sodium. Calculate the quantity, in mg, of cephalothin (C16H16N2O6S2) in the container, and in the portion of constituted solution taken by the formula:
(L / D)(CP / 1000)(rU / rS)in which L is the labeled quantity of cephalothin in the container, or in the volume of constituted solution taken; D is the concentration, in mg per mL, of cephalothin in Assay preparation 1 or in Assay preparation 2, on the basis of the labeled quantity in the container, or in the portion of constituted solution taken, respectively, and the extent of dilution; and the other terms are as defined therein. Where the test for Uniformity of dosage units has been performed using the Procedure for content uniformity, use the average of these determinations as the Assay value.
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USP32NF27 Page 1875
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.