Chlorothiazide Sodium for Injection
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Chlorothiazide Sodium for Injection is a sterile, freeze-dried mixture of Chlorothiazide Sodium (prepared by the neutralization of Chlorothiazide with the aid of Sodium Hydroxide) and Mannitol. It contains chlorothiazide sodium (C7H5ClN3NaO4S2) equivalent to not less than 93.0 percent and not more than 107.0 percent of the labeled amount of chlorothiazide (C7H6ClN3O4S2).
Packaging and storage—Preserve as described in Packaging and Storage Requirements 〈659〉, Injection Packaging, Packaging for constitution.
USP REFERENCE STANDARDS 〈11〉—
USP Chlorothiazide RS
Constituted solution—At the time of use, it meets the requirements for Injections and Implanted Drug Products 〈1〉, Specific Tests, Completeness and clarity of solutions.
Change to read:
Identification, Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy : 197U (CN 1-May-2020) — Solution: 10 µg per mL.
Medium: sodium hydroxide solution (1 in 250).
BACTERIAL ENDOTOXINS TEST 〈85〉 —It contains not more than 0.3 USP Endotoxin Unit per mg of chlorothiazide sodium. UNIFORMITY OF DOSAGE UNITS 〈905〉: meets the requirements.
PH 〈791〉: between 9.2 and 10.0, in a solution prepared as directed in the labeling.
Other requirements—It meets the requirements under Injections and Implanted Drug Products 〈1〉.
Assay—Transfer an accurately weighed portion of Chlorothiazide Sodium for Injection, equivalent to about 500 mg of chlorothiazide, to a 1000- mL volumetric flask, add sodium hydroxide solution (1 in 250) to volume, and mix. Transfer 5.0 mL of this solution to a 250-mL volumetric flask, dilute with sodium hydroxide solution (1 in 250) to volume, and mix. Concomitantly determine the absorbances of this solution and a Standard solution of USP Chlorothiazide RS in the same medium having a known concentration of about 10 µg per mL in 1-cm cells at the wavelength of maximum absorbance at about 292 nm, with a suitable spectrophotometer, using sodium hydroxide solution (1 in 250) as the blank. Calculate the quantity, in mg, of C7H6ClN3O4S2 in the portion of Chlorothiazide Sodium for Injection taken by the formula:
50C(AU/AS)
in which C is the concentration, in µg per mL, of USP Chlorothiazide RS in the Standard solution; and AU and AS are the absorbances of the assay solution and the Standard solution, respectively.
