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Promazine Hydrochloride Injection

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26 views1 page

Promazine Hydrochloride Injection

Uploaded by

ghofrane ekvl
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Printed on: Sat Jul 31 2021, 06:05:35 PM Official Status: Currently Official on 31-Jul-2021 DocId: 1_GUID-64E720E8-627A-40DC-9549-73D9C97F5798_3_en-US

(EST)
Printed by: Le Tran Official Date: Official as of 01-May-2018 Document Type: USP @2021 USPC
1

Other requirements—It meets the requirements under


Promazine Hydrochloride Injection Injections and Implanted Drug Products á1ñ.
Assay— [NOTE—Use low-actinic glassware.] Transfer a volume
» Promazine Hydrochloride Injection is a sterile of Injection, equivalent to about 50 mg of promazine
hydrochloride, to a 100-mL volumetric flask, dilute with 0.1 N
solution of Promazine Hydrochloride in Water for hydrochloric acid to volume, and mix. Transfer 10.0 mL of the
Injection. It contains not less than 95.0 percent and solution to a 250-mL separator, add 20 mL of water, render
not more than 110.0 percent of the labeled alkaline with ammonium hydroxide, and extract with four
amount of C17H20N2S · HCl. 25-mL portions of ether. Extract the combined ether extracts
with five 15-mL portions of 0.1 N hydrochloric acid, collecting
Packaging and storage—Preserve in single-dose or in the aqueous extracts in a 100-mL volumetric flask. Aerate to
multiple-dose containers, preferably of Type I glass, protected remove residual ether, dilute with 0.1 N hydrochloric acid to
from light. volume, and mix. Without delay, concomitantly determine the
USP Reference standards á11ñ— absorbances of this solution and of a Standard solution of USP
USP Promazine Hydrochloride RS Promazine Hydrochloride RS in the same medium having a
[NOTE—Throughout the following procedures, protect known concentration of about 50 µg per mL in 1-cm cells at
test or assay specimens, the Reference Standard, and the wavelength of maximum absorbance at about 301 nm,
solutions containing them, by conducting the procedures with a suitable spectrophotometer, using 0.1 N hydrochloric
without delay, under subdued light, or using low-actinic acid as the blank. Calculate the quantity, in mg, of C17H20N2S
glassware.] · HCl in each mL of the Injection taken by the formula:
Identification— (C/V)(A U/A S)
A: It meets the requirements under Identification—Organic

al
Nitrogenous Bases á181ñ. in which C is the concentration, in µg per mL, of USP
B: It responds to Identification test B under Promazine Promazine Hydrochloride RS in the Standard solution, V is the
Hydrochloride. volume, in mL, of Injection taken, and A U and A S are the
Bacterial Endotoxins Test á85ñ —It contains not more than absorbances of the solution from the Injection and the
1.8 USP Endotoxin Units per mg of promazine hydrochloride. Standard solution, respectively.
pH á791ñ: between 4.0 and 5.5.
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