Ceftriaxone for Injection
»Ceftriaxone for Injection contains an amount of Ceftriaxone Sodium equivalent to not less than 776µg of ceftriaxone (C18H18N8O7S3)per mg,calculated on the anhydrous basis,and the equivalent of not less than 90.0percent and not more than 115.0percent of the labeled amount of ceftriaxone (C18H18N8O7S3).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Bacterial endotoxins á85ñ— It contains not more than 0.20USP Endotoxin Unit per mg of ceftriaxone.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It responds to the Identificationtests and meets the requirements for Crystallinity,pH,and Waterunder Ceftriaxone SodiumIt meets also the requirements for Uniformity of Dosage Units á905ñand for Labelingunder Injections á1ñ.
Assay—
pH7.0buffer,pH5.0buffer,Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Prepare as directed in the Assayunder Ceftriaxone Sodium.
Assay preparation 1— Transfer about 40mg of Ceftriaxone for Injection,accurately weighed,to a 200-mLvolumetric flask,dissolve in and dilute with Mobile phaseto volume,and mix.Use this solution promptly after preparation.
Assay preparation 2 (where it is represented as being in a single-dose container)—Constitute Ceftriaxone 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 phaseto obtain a solution containing about 180µg of ceftriaxone per mL.Use this solution promptly after preparation.
Assay preparation 3 (where the label states the quantity of ceftriaxone in a given volume of constituted solution)—Constitute Ceftriaxone for Injection in a volume of water,accurately measured,corresponding to the volume of solvent specified in the labeling.Dilute an accurately measured volume of the constituted solution quantitatively with Mobile phaseto obtain a solution containing about 180µg of ceftriaxone per mL.Use this solution promptly after preparation.
Procedure— Proceed as directed in the Assayunder Ceftriaxone Sodium.Calculate the quantity,in µg,of ceftriaxone(C18H18N8O7S3)per mg of the Ceftriaxone for Injection taken by the formula:
200(CP/W)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Ceftriaxone Sodium RSin the Standard preparation;Pis the designated potency,in µg,of ceftriaxone per mg of USP Ceftriaxone Sodium RS;Wis the quantity,in mg,of Ceftriaxone for Injection taken to prepare Assay preparation 1;and rUand rSare the ceftriaxone peak responses obtained from Assay preparation 1and the Standard preparation,respectively.Calculate the quantity,in mg,of ceftriaxone (C18H18N8O7S3)withdrawn from the container,or in the portion of constituted solution taken by the formula:
(L/D)(CP)(rU/rS),
in which Lis the labeled quantity,in mg,of ceftriaxone (C18H18N8O7S3)in the container,or in the volume of constituted solution taken;Dis the concentration,in µg per mL,of ceftriaxone in Assay preparation 2or Assay preparation 3,based on the labeled quantity in the container or in the portion of constituted solution taken,respectively,and the extent of dilution;Cis the concentration,in mg per mL,of USP Ceftriaxone Sodium RSin the Standard preparation;Pis the designated potency,in µg,of ceftriaxone per mg of USP Ceftriaxone Sodium RS;and rUand rSare the ceftriaxone 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 406
Phone Number:1-301-816-8335