Yohimbine Injection

Printed on: Tue Aug 03 2021, 07:36:13 AM Official Status: Currently Official on 03-Aug-2021 DocId: 1_GUID-09409A82-B859-42F2-AA3A-39F08FCA1C88_3_en-US
(EST)
Printed by: Le Tran Official Date: Official as of 01-May-2018 Document Type: USP @2021 USPC
1
1-decanesulfonate in each 1000 mL. Make adjustments if

Yohimbine Injection necessary (see System Suitability under Chromatography
á621ñ).
» Yohimbine Injection is a sterile solution of Standard preparation—Transfer about 55 mg of USP
Yohimbine Hydrochloride RS, accurately weighed, to a 25-mL
Yohimbine Hydrochloride in Water for Injection. It volumetric flask, add 20 mL of water, warm, and swirl to
contains not less than 90.0 percent and not more dissolve. Add 84 mg of anhydrous citric acid, and swirl to
than 110.0 percent of the labeled amount of dissolve. Allow the solution to cool, adjust with 1 N sodium
yohimbine (C 21 H 26 N 2 O 3). hydroxide to a pH of 4.0, dilute with water to volume, and
mix. Transfer 125.0 µL of this stock solution to a second 25-mL
Packaging and storage—Preserve in single-dose or volumetric flask, dilute with Diluent to volume, and mix. This
multiple-dose containers as described in Packaging and Storage solution contains about 0.011 mg of USP Yohimbine
Requirements á659ñ, Injection Packaging. Store at controlled Hydrochloride RS per mL.
room temperature. Resolution solution—Prepare a solution in methanol
Labeling—Where it is intended for veterinary use only, it is containing about 0.56 mg of methylparaben and 0.06 mg of
so labeled. propylparaben per mL. Transfer 200 µL of this solution to a
USP Reference standards á11ñ— 25-mL volumetric flask, add 125.0 µL of the stock solution
USP Yohimbine Hydrochloride RS used to prepare the Standard preparation, dilute with Diluent
to volume, and mix.
Identification, Thin-Layer Chromatographic Identification Assay preparation—Transfer an accurately measured
Test á201ñ— volume of Injection, equivalent to about 0.25 mg of
Test solution—Transfer a volume of Injection, equivalent to yohimbine, to a 25-mL volumetric flask, dilute with Diluent to
about 40 mg of yohimbine, to a separator, add 5 mL of a volume, and mix.
al
sodium carbonate solution (1 in 20), and extract with four Chromatographic system (see Chromatography á621ñ)—The
10-mL portions of chloroform, combining the chloroform liquid chromatograph is equipped with a 254-nm detector
extracts in a beaker and evaporating to dryness. Add 20 mL of and a 3.9-mm × 15-cm column that contains 5-µm packing
methanol to the beaker, and swirl to dissolve the residue. L1. The flow rate is about 1 mL per minute. Chromatograph
Standard solution—Prepare a solution of USP Yohimbine the Resolution solution, and record the peak responses as
Hydrochloride RS in methanol containing 2 mg per mL.
Mixed solution: a mixture of the Test solution and the
Standard solution (1:1).
ci directed for Procedure: the relative retention times are about
0.4 for methylparaben, 0.7 for propylparaben, and 1.0 for
yohimbine; and the resolution, R, between methylparaben
Application volume: 1 µL. and propylparaben and between propylparaben and
Developing solvent system: methylene chloride, methanol, yohimbine is not less than 2.0. Chromatograph the Standard
ffi
and ammonium hydroxide (90:14:1), in a saturated chamber. preparation, and record the peak responses as directed for
Procedure—Allow the plate to air-dry in a hood. Expose the Procedure: the relative standard deviation for replicate
dry plate for 30 minutes to short-wavelength UV light, then injections is not more than 2.0%.
examine under long-wavelength UV light: the size, intensity, Procedure—Separately inject equal volumes (about 25 µL)
and R F value of the principal spots in the chromatograms of the Standard preparation and the Assay preparation into the
obtained from the Test solution and the Mixed solution chromatograph, record the chromatograms, and measure the
O
correspond to those characteristics of the principal spot in the areas for the major peaks. Calculate the quantity, in mg, of
chromatogram obtained from the Standard solution. yohimbine (C 21 H 26 N 2 O 3) in each mL of the Injection taken
Bacterial Endotoxins Test á85ñ—It contains not more than by the formula:
45.5 USP Endotoxin Units per mg of yohimbine.
Sterility Tests á71ñ—It meets the requirements when tested (354.45/390.90)(25,000C/V)(r U/r S)
as directed for Membrane Filtration under Test for Sterility of the
Product to be Examined. in which 354.45 and 390.90 are the molecular weights of
pH á791ñ: between 3.7 and 4.3. yohimbine and yohimbine hydrochloride, respectively; C is the
Other requirements—It meets the requirements under concentration, in mg per mL, of USP Yohimbine
Injections and Implanted Drug Products á1ñ. Hydrochloride RS in the Standard preparation; V is the volume,
in µL, of Injection taken to prepare the Assay preparation; and
Assay— r U and r S are the yohimbine peak responses obtained from the
Diluent—Prepare a mixture of acetonitrile, water, and Assay preparation and the Standard preparation, respectively.
glacial acetic acid (49:49:2).
Mobile phase—Prepare a mixture of water, acetonitrile, and
glacial acetic acid (603:377:20) containing 3.5 g of sodium
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Printed on: Tue Aug 03 2021, 07:36:13 AM Official Status: Currently Official on 03-Aug-2021 DocId: 1_GUID-09409A82-B859-42F2-AA3A-39F08FCA1C88_3_en-US

1-decanesulfonate in each 1000 mL. Make adjustments if

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