Promazine Hydrochloride Tablets
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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)
Promazine Hydrochloride Tablets contain not less than 95.0 percent and not more than 110.0 percent of the labeled amount of C17H20N2S.HCl
Packaging and storage—Preserve in tight, light-resistant containers.
USP Reference standards 〈11〉—
USP Promazine Hydrochloride RS
[Note—Throughout the following procedures, protect test or assay specimens, the Reference Standard, and solutions containing them, by conducting the procedures without delay, under subdued light, or using low-actinic glassware.]
Identification—
A: Shake a portion of powdered Tablets, equivalent to about 50 mg of promazine hydrochloride, with 25 mL of 0.01 N hydrochloric acid for 5 minutes, and filter: the solution meets the requirements under Identification—Organic Nitrogenous Bases 〈181〉.
B: It responds to Identification test B under Promazine Hydrochloride.
Disintegration 〈701〉: 30 minutes, with disks.
Uniformity of dosage units 〈905〉: meet the requirements.
Assay—[Note—Use low-actinic glassware.] Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 50 mg of promazine hydrochloride, to a 100-mL volumetric flask. Add 50 mL of 0.1 N hydrochloric acid, and shake by mechanical means for about 1 hour. Dilute with 0.1 N hydrochloric acid to volume, mix, and centrifuge a portion of the mixture. Transfer 10.0 mL of the clear, supernatant to a 250-mL separator, and proceed as directed in the Assay under Promazine Hydrochloride Injection, beginning with “add 20 mL of water.” Calculate the quantity, in mg, of C17H20N2S.HCl in the portion of Tablets taken by the formula:
C(AU/AS)
in which C is the concentration, in µg per mL, of USP Promazine Hydrochloride RS in the Standard solution, and AU and AS are the absorbances of the solution from the Tablets and the Standard solution, respectively.
