Cefotiam for Injection
»Cefotiam for Injection contains an amount of Cefotiam Hydrochloride equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of cefotiam (C18H23N9O4S3).It may contain Sodium Carbonate.
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Identification—
Solution: 20µg per mL.
Medium: water.
B: The retention time of the cefotiam peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparationas obtained in the Assay.
Pyrogen— It meets the requirements of the Pyrogen Test á151ñ,the test dose being 1.0mLper kg of a solution prepared by diluting Cefotiam for Injection with Sterile Water for Injection to a concentration of 40mg of cefotiam per mL.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 5.7and 7.2,in a solution containing the equivalent of 100mg of cefotiam per mL.
Loss on drying á731ñ— Dry about 100mg,accurately weighed,in vacuum at a pressure not exceeding 5mm of mercury at 60for 3hours:it loses not more than 6.0%of its weight.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Assay—
Mobile phase ,Standard preparation,System suitability,and Chromatographic system—Prepare as directed in the Assayunder Cefotiam Hydrochloride.
Assay preparation 1 (where it is represented as being in a single-dose container)—Constitute a container of Cefotiam for Injection in a volume of water,accurately measured,corresponding to the volume of diluent specified in the labeling.Withdraw all of the withdrawable contents,using a suitable hypodermic needle and syringe,and dilute quantitatively with water to obtain a solution containing the equivalent of about 1mg of cefotiam (C18H23N9O4S3)per mL.Transfer 5.0mLof this solution to a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.This solution contains the equivalent of about 50µg of cefotiam per mL.Use this solution without delay.
Assay preparation 2 (where the label states the quantity of cefotiam in a given volume of constituted solution)—Constitute a container of Cefotiam for Injection in a volume of water,accurately measured,equivalent to the volume of diluent specified in the labeling.Dilute an accurately measured volume of the constituted solution quantitatively with water to obtain a solution containing about 1mg of cefotiam (C18H23N9O4S3)per mL.Transfer 5.0mLof this solution to a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.This solution contains the equivalent of about 50µg of cefotiam per mL.Use this solution without delay.
Procedure— Proceed as directed for Procedurein the Assayunder Cefotiam Hydrochloride.Calculate the quantity,in mg,of cefotiam (C18H23N9O4S3)withdrawn from the container,or in the portion of constituted solution taken by the formula:
C(L/D)(rU/rS),
in which Cis the concentration,in µg per mL,of cefotiam (C18H23N9O4S3)in the Standard preparation,based on the quantity of USP Cefotiam Hydrochloride RStaken to prepare the Standard preparation,the designated cefotiam (C18H23N9O4S3)content,in µg per mg,of USP Cefotiam Hydrochloride RS,and the extent of dilution;Lis the labeled quantity,in mg,of cefotiam (C18H23N9O4S3)in the container,or in the volume of constituted solution taken;Dis the concentration,in µg of cefotiam per mL,of Assay preparation 1or Assay preparation 2,based on the labeled quantity in the container or in the volume of constituted solution taken,respectively,and the extent of dilution;and rUand rSare the cefotiam peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 393
Phone Number:1-301-816-8335