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.
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.
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 (C
18H
23N
9O
4S
3) withdrawn from the container, or in the portion of constituted solution taken by the formula: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 (C
18H
23N
9O
4S
3) in the
Standard preparation, based on the quantity of
USP Cefotiam Hydrochloride RS taken to prepare the
Standard preparation, the designated cefotiam (C
18H
23N
9O
4S
3) content, in µg per mg, of
USP Cefotiam Hydrochloride RS, and the extent of dilution;
L is the labeled quantity, in mg, of cefotiam (C
18H
23N
9O
4S
3) 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.
