Diazoxide Injection
» Diazoxide Injection is a sterile solution of Diazoxide in Water for Injection, prepared with the aid of Sodium Hydroxide. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C8H7ClN2O2S.
Packaging and storage
Preserve in single-dose containers, preferably of Type I glass, protected from light.
Identification
A:
A dilution of the Injection in methanol containing 1 mg of diazoxide per mL responds to the Thin-layer Chromatographic Identification Test 201, a solution of USP Diazoxide RS in methanol containing 1 mg per mL being used as the Standard solution. Develop the chromatogram with a solvent system consisting of a mixture of ethyl acetate, methanol, and ammonium hydroxide (17:4:3).
B:
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation, both relative to the internal standard, as obtained in the Assay.
Bacterial endotoxins 85
It contains not more than 0.5 USP Endotoxin Unit per mg of diazoxide.
pH 791:
between 11.2 and 11.9.
Other requirements
It meets the requirements under Injections 1.
Assay
Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system
Prepare as directed in the Assay under Diazoxide.
Assay preparation
Transfer an accurately measured volume of Injection, equivalent to about 45 mg of diazoxide, to a 50-mL volumetric flask, dilute with methanol to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, add 2.0 mL of Internal standard solution, dilute with a mixture of water and methanol (4:1) to volume, and mix.
Procedure
Proceed as directed for Procedure in the Assay under Diazoxide. Calculate the quantity, in mg, of C8H7ClN2O2S in each mL of the Injection taken by the formula:
C / V(RU / RS)
in which C is the concentration, in µg per mL, of USP Diazoxide RS in the Standard preparation; V is the volume, in mL, of Injection taken; and RU and RS are the peak response ratios obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information
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Chromatographic Column
USP32NF27 Page 2117
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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