Cefotiam for Injection
» Cefotiam for Injection contains an amount of Cefotiam Hydrochloride equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of cefotiam (C18H23N9O4S3). It may contain Sodium Carbonate.
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.
USP Reference standards 11
USP Cefotiam Hydrochloride RS Click to View Structure
Identification—
Solution: 20 µg per mL.
Medium: water.
B: The retention time of the cefotiam peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation; as obtained in the Assay.
Pyrogen— It meets the requirements of the Pyrogen Test 151, the test dose being 1.0 mL per kg of a solution prepared by diluting Cefotiam for Injection with Sterile Water for Injection to a concentration of 40 mg of cefotiam per mL.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 5.7 and 7.2, in a solution containing the equivalent of 100 mg of cefotiam per mL.
Loss on drying 731 Dry about 100 mg, accurately weighed, in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: it loses not more than 6.0% of its weight.
Particulate matter 788: meets the requirements for small-volume injections.
Assay—
Mobile phase , Standard preparation, System suitability solution, and Chromatographic system—Prepare as directed in the Assay under 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 1 mg of cefotiam (C18H23N9O4S3) per mL. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix. This solution contains the equivalent of about 50 µg 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 1 mg of cefotiam (C18H23N9O4S3) per mL. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix. This solution contains the equivalent of about 50 µg of cefotiam per mL. Use this solution without delay.
Procedure— Proceed as directed for Procedure in the Assay under 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 C is the concentration, in µg per mL, of cefotiam (C18H23N9O4S3) in the Standard preparation, based on the quantity of USP Cefotiam Hydrochloride RS taken to prepare the Standard preparation, the designated cefotiam (C18H23N9O4S3) content, in µg per mg, of USP Cefotiam Hydrochloride RS, and the extent of dilution; L is the labeled quantity, in mg, of cefotiam (C18H23N9O4S3) in the container, or in the volume of constituted solution taken; D is the concentration, in µg of cefotiam per mL, of Assay preparation 1 or 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 rU and rS are the cefotiam peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Senior Scientific Liaison
1-301-816-8161
(SM12010) Monographs - Small Molecules 1
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
71 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
1-301-816-8339
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 2563