Printed on: Fri Jan 05 2024, 09:01:12 PM(EST) Status: Currently Official on 06-Jan-2024 DocId: GUID-3C267BC4-1AB1-4394-B39C-40E529CCB8BF_4_en-US

Printed by: USP NF Official Date: Official as of 01-May-2020 Document Type: USP @2024 USPC
Do Not Distribute DOI Ref: g29io DOI: https://doi.org/10.31003/USPNF_M89238_04_01
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100r s/(r U + r s)
Xylazine Hydrochloride
in which r s is the sum of the areas of all the impurity peaks
C12H16N2S · HCl 256.79 observed; and r U is the area of the xylazine peak: the sum of
4H-1,3-Thiazin-2-amine, N-(2,6-dimethylphenyl)-5,6- the impurity responses is not greater than 2.0%.
dihydro-, monohydrochloride.
Assay—
5,6-Dihydro-2-(2,6-xylidino)-4H-1,3-thiazine hydrochloride
Mobile phase—Dissolve 6.0 g of sodium 1-heptanesulfo
CAS RN®: 23076-35-9; UNII: NGC3S0882S.
nate in 2500 mL of water, add 60 mL of glacial acetic acid,
dilute with water to 3000 mL, and mix. Prepare a mixture of
» Xylazine Hydrochloride contains not less than 2200 mL of this solution and 1800 mL of methanol, and pass
98.0 percent and not more than 102.0 percent through a filter having a 0.5-µm or finer porosity. Make
of C12H16N2S · HCl. adjustments if necessary (see System Suitability under
Chromatography á621ñ).
Packaging and storage—Preserve in tight containers. Store Standard preparation—Prepare a solution of USP Xylazine
at 25°, excursions permitted between 15° and 30°. Hydrochloride RS in Mobile phase having a known
Labeling—Where it is intended for veterinary use only, the concentration of about 1 mg per mL.
label so states. Assay preparation—Transfer about 25 mg of Xylazine
USP Reference standards á11ñ— Hydrochloride, accurately weighed, to a 25-mL volumetric
USP Xylazine Hydrochloride RS flask, dissolve in and dilute with Mobile phase to volume,
and mix.
Identification— Chromatographic system (see Chromatography á621ñ)—The
liquid chromatograph is equipped with a 254-nm detector, a

al
Change to read:
2-mm × 2-cm guard column that contains packing L1, and a
A: ▲Spectroscopic Identification Tests á197ñ, Infrared 3.9-mm × 30-cm analytical column that contains packing
Spectroscopy: 197K▲ (CN 1-May-2020). L1 and is maintained at a constant temperature of about 40°.
B: Thin-Layer Chromatographic Identification Test á201ñ— The flow rate is about 2.5 mL per minute. Chromatograph the
Test solution: 5 mg per mL, in methanol. Standard preparation, and record the peak responses as
Developing solvent system: methanol and ammonium
hydroxide (98.5: 1.5).
Procedure—Separately apply 1 µL of the Test solution and the
ci directed for Procedure: the relative standard deviation for
replicate injections is not more than 2.0%. [NOTE—After daily
use, rinse the column with 100 mL of acetonitrile and with
Standard solution. Allow the applications to dry with the aid 100 mL of methanol, and store the column containing
of a stream of nitrogen, develop in a saturated methanol.]
ffi
chromatographic chamber, and dry the plate in a current of Procedure—Separately inject equal volumes (about 20 µL)
air: the size, intensity, and R F value of the principal spot of the Standard preparation and the Assay preparation into the
obtained from the Test solution correspond to those of the chromatograph, record the chromatograms, and measure the
principal spot obtained from the Standard solution. responses for the major peaks. Calculate the quantity, in mg,
Melting range á741ñ: between 164° and 168°. of C12H16N2S · HCl in the portion of Xylazine Hydrochloride
pH á791ñ: between 4.0 and 6.0, in a solution (1 in 100). taken by the formula:
O

Loss on drying á731ñ—Dry it at 105° for 4 hours: it loses not

more than 1.0% of its weight. 25C(r U/r S)
Residue on ignition á281ñ: not more than 0.1%.
Chromatographic purity—Examine the chromatogram in which C is the concentration, in mg per mL, of USP Xylazine
obtained from the Assay preparation. Calculate the percentage Hydrochloride RS in the Standard preparation; and r U and r S
of impurities in the Xylazine Hydrochloride taken by the are the areas of the xylazine peak responses in the
formula: chromatograms obtained from the Assay preparation and the
Standard preparation, respectively.

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