Isoxsuprine hydrochloride

Accessed from 128.83.63.20 by nEwp0rt1 on Thu Nov 24 23:35:39 EST 2011 3600 Isotretinoin / Official Monographs sponses. Calculate the per centage of isotretinoin dissolved by Assay—[NOTE—Protect the System suitability solution, the Stan-
dard preparation, the Assay stock preparation, and the Assay Diluent—Heat 0.1 N sodium hydroxide to about 60 ° to 70 °.
Cool it to room temperature and purge with helium or nitro- gen. Store it in a plastic container.
Solvent A—Prepare a solution of 0.5% acetic acid in in rU and rS are the peak responses for the Test solution and the Solvent B—Prepare a solution of 0.5% acetic acid in water.
Standard solution, respectively; CS is the concentration, in mg per mL, of the Standard solution; 900 is the volume, in mL, of Mobile phase—Prepare a mixture of Solvent A and Solvent B Medium; 100 is the per centage conversion factor; and L is the (71:29). Make adjustments if necessar y (see System Suitability under Chromatography 〈621〉).
Tolerances—Not less than 70% (Q) of the labeled amount of System suitability solution—Dissolve suitable quantities of USP Isotretinoin RS and USP T retinoin RS in Diluent to obtain a solu- tion having known concentrations of about 0.04 mg per mL of Uniformity of dosage units 〈905〉: meet the requirements.
isotretinoin and 0.02 mg per mL of tretinoin.
Chromatographic purity—
Standard preparation—Dissolve an accurately weighed quan- Methylene chloride reagent—Transfer 50 g of sodium bicarbo- tity of USP Isotretinoin RS in Diluent, and dilute with Diluent, nate to 1000 mL of methylene chloride, shake, and allow to stepwise if necessar y, to obtain a solution having a known stand overnight. At the time of use, filter suitable portions of concentration of about 0.04 mg per mL.
this solution, and add 10 mg of butylated hydroxytoluene per Assay stock preparation—Transfer not fewer than 10 Capsules to a suitable volumetric flask. Add Diluent to the volumetric Mobile phase—Prepare a filtered and degassed mixture of flask to fill about 50% of the volume, sonicate for 1 hour with hexanes, ethyl acetate, and glacial acetic acid (970:30:0.1).
occasional shaking to disperse all the contents, and make up Make adjustments if necessar y (see System Suitability under the volume with Diluent to obtain a solution having a known concentration of about 0.4 mg per mL of isotretinoin.
System suitability solution—Dissolve accurately weighed quan- Assay preparation—Transfer 5 mL of the Assay stock prepara- tities of USP Isotretinoin RS and USP Tretinoin RS in Methylene tion to a 50-mL volumetric flask, and dilute with Diluent to vol- chloride reagent to obtain a solution having known concentra- ume. Pass the solution through a suitable 0.45- µm or finer tions of about 1 mg of each Reference Standard per mL. T rans- fer 1.0 mL of this solution, and dilute quantitatively with hex- Chromatographic system (see Chromatography 〈621〉)—The anes to 100.0 mL to obtain a solution having known liquid chromatograph is equipped with a 353-nm detector and concentrations of about 0.01 mg of each Reference Standard a 4.6-mm × 25-cm column containing packing L1. The flow rate is about 1.5 mL per minute. Chromatograph the System Standard solution—Dissolve an accurately weighed quantity suitability solution, and record the peak areas as directed for of USP Tretinoin RS in Methylene chloride reagent to obtain a Procedure: the relative retention times for isotretinoin and treti- solution having a known concentration of about 0.5 mg per noin are about 1.0 and 1.3, respectively; the resolution, R, be- mL. Dilute an accurately measured volume of this solution tween isotretinoin and tretinoin is not less than 2.0; the tailing quantitatively, and stepwise if necessar y, with hexanes to obtain factor for the isotretinoin peak is not greater than 2.0; and the a solution having a known concentration of about 1 µg per mL.
column efficiency determined from the isotretinoin peak is not Test solution—Weigh a number of Capsules, equivalent to less than 2000. Chromatograph the Standard preparation, and about 200 mg of isotretinoin. W ith a sharp blade, carefully record the peak areas as directed for Procedure: the relative open the Capsules, without loss of material, and transfer the standard deviation for replicate injections is not more than contents by pipetting 5 mL of Methylene chloride reagent over each Capsule and rinsing with hexanes. Collect the washings in Procedure—Separately inject equal volumes (about 20 µL) of a 500-mL volumetric flask, dilute with hexanes to volume, and the Standard preparation and the Assay preparation into the mix. Transfer 50.0 mL of this solution to a 200-mL volumetric chromatograph, record the chromatograms, and measure the flask, dilute with hexanes to volume, and mix to obtain a solu- areas for the major peaks. Calculate the quantity, in mg, of tion having a concentration of about 0.1 mg of isotretinoin per isotretinoin (C20H28O2) in each of the Capsules taken by the Chromatographic system (see Chromatography 〈621〉)—The liquid chromatograph is equipped with a 365-nm detector and a 4.6-mm × 25-cm column containing packing L3. The flow rate is about 1 mL per minute. Chromatograph the System suit- in which C is the concentration, in mg per mL, of isotretinoin ability solution [NOTE—The injection volume is about 20 µL.], in the Standard preparation; V is the volume, in mL, of the vol- and record the peak responses as directed for Procedure: the umetric flask used to prepare the Assay stock preparation; N is relative retention times for isotretinoin and tretinoin are about the number of Capsules taken; and rU and rS are the isotretinoin 0.75 and 1.00, respectively; the resolution, R, between isotreti- peak areas obtained from the Assay preparation and the Stan- noin and tretinoin is not less than 3.0; the tailing factor for the dard preparation, respectively.
isotretinoin peak is not greater than 2.5; and the relative stan- dard deviation for replicate injections is not more than 2.0%.
Procedure—Separately inject equal volumes (about 50 µL) of the Standard solution and the Test solution into the chromato- Isoxsuprine Hydrochloride
graph, and allow the Test solution to elute for not less than two times the retention time of isotretinoin. Record the chromato- grams, and measure the peak responses: the peak response for any impurity is not more than that of the tretinoin response obtained from the Standard solution (1.0%); and the sum of all the peak responses, excluding that of isotretinoin, obtained from the Test solution, is not more than 1.5 times the tretinoin response obtained from the Standard solution (1.5%).
Benzenemethanol, 4-hydroxy-α-[1-[(1-methyl-2-phenoxyethy- l)amino]ethyl]-, hydrochloride, stereoisomer.
Official from May 1, 2012Copyright (c) 2011 The United States Pharmacopeial Convention. All rights reserved.
Accessed from 128.83.63.20 by nEwp0rt1 on Thu Nov 24 23:35:39 EST 2011 Official Monographs / Isoxsuprine 3601 p-Hydroxy-α-[1-[(1-methyl-2-phenoxyethyl)amino]ethyl]benzyl enthetic expressions are the differences in the absorbances of the two solutions at the wavelengths indicated by the sub- (±)-(αR*)-p-Hydroxy-α-[(1S*)-1-[[(1S*)-1-methyl-2-phenoxyethyl] scripts, for the assay solution ( U) and the Standard solution ( S), amino]ethyl]benzyl alcohol hydrochloride [579-56-6; 34331- » Isoxsuprine Hydrochloride contains not less than 97.0 percent and not more than 103.0 per- Isoxsuprine Hydrochloride Injection
cent of C 18H23NO3 · HCl, calculated on the dried » Isoxsuprine Hydrochloride Injection is a sterile Packaging and storage—Preserve in tight containers.
solution of Isoxsuprine Hydrochloride in W ater for Injection. It contains not less than 95.0 per- USP Reference standards 〈11〉
cent and not more than 105.0 per cent of the labeled amount of C 18H23NO3 · HCl.
Identification—
A: Infrared Absorption 〈197K〉.
Packaging and storage—Preserve in single-dose or in multi-
B: Ultraviolet Absorption 〈197U〉—
ple-dose containers, preferably of T ype I glass.
USP Reference standards 〈11〉
C: To 1 mL of a solution (1 in 100), obtained by heating as
necessary, add 3 mL of a 1 in 15 solution of sodium nitrite in Identification—To a 60-mL separator transfer 10 mL of pH
2 N sulfuric acid. Add ammonium hydroxide dropwise: a yellow 9.0 buffer (prepared by mixing equal volumes of 0.1 M mono- precipitate is formed and it dissolves upon the addition of so- basic potassium phosphate and 0.1 N sodium hydroxide and, using a pH meter, adjusting to a pH of 9.0 by adding, as neces- D: To 1 mL of a solution (1 in 100) add 1 mL of phospho-
sary, more of either solution) add 1 mL of Injection, and mix.
molybdic acid solution (1 in 100): a pale yellow to white pre- Add 2 mL of chloroform, shake vigorously for 1 minute, filter the chloroform extract through a pledget of cotton, and mix pH 〈791〉: between 4.5 and 6.0, in a solution (1 in 100).
the filtrate with 500 mg of potassium bromide. Evaporate the chloroform, carefully removing the last trace of solvent in a Loss on drying 〈731〉Dry it at 105 ° for 1 hour: it loses not
small vacuum flask: the IR absorption spectrum of a potassium bromide dispersion of the isoxsuprine so obtained exhibits max- Residue on ignition 〈281〉: not more than 0.2%.
ima only at the same wavelengths as that of a similar prepara- Heavy metals, Method II 〈231〉: 0.002%.
tion of USP Isoxsuprine Hydrochloride RS that has been treated Related compounds—To 10 mg, accurately weighed in a
suitable vial, add 1 mL of N-trimethylsilylimidazole, and heat at Bacterial endotoxins 〈85〉It contains not more than 35.70
65° for 10 minutes. Add 5 mL of isooctane, wash with one 3- USP Endotoxin Units per mg of isoxsuprine hydrochloride.
mL portion of water, and allow the layers to separate. Inject a pH 〈791〉: between 4.9 and 6.0.
2-µL portion of the isooctane solution into a gas chromato- Other requirements—It meets the requirements under Injec-
graph equipped with a 0.3-cm × 2.0-m glass column packed with packing S1A containing 3% liquid phase G2 and a flame- ionization detector. The column temperature is maintained at Assay—
215°, and the injection port and detector are maintained at pH 4.0 Citrate buffer—Mix equal volumes of 0.5 M citric acid 250°. The carrier gas is nitrogen, flowing at the rate of 25 mL and 0.5 M sodium citrate, and adjust, by the addition of either per minute. Adjust the instrument to provide full-scale response solution as necessar y, the pH of the solution to 4.0 ± 0.2.
for the major component. Inject a second 2- µL portion of the Mixed solvent—Shake 40 mL of ether, 160 mL of isooctane, isooctane solution with the attenuator adjusted to an 8-fold in- and 10 mL of water in a separator, remove and discard the crease in sensitivity, and record the chromatogram from 0.5 to water phase, and pass the solvent phase through a large 1.5 relative to the retention time of the major peak. Measure pledget of cotton to remove excess water.
the area of all minor peaks, and correct for differences in sensi- Standard preparation—Transfer about 40 mg of USP Isox- tivity settings. Calculate the per centage of related compounds suprine Hydrochloride RS , accurately weighed, to a 50-mL volu- metric flask, add 2 N sulfuric acid to volume, and mix. T ransfer 10.0 mL of this solution to a 100-mL volumetric flask, dilute with 2 N sulfuric acid to volume, and mix. The concentration of USP Isoxsuprine Hydrochloride RS in the Standard preparation is in which A is the sum of the corrected area peaks for all minor peaks, and B is the sum of the corrected area peaks for the major and minor peaks. Not more than 2.0% is found.
Chromatographic column—Proceed as directed under Column Partition Chromatography (see Chromatography 〈621〉), packing a Assay—Transfer about 50 mg of Isoxsuprine Hydrochloride, ac-
chromatographic tube with two segments of packing material.
curately weighed, to a 1000-mL volumetric flask, add water to The lower segment is a mixture of 2 g of Solid Support and 1 volume, and mix. Concomitantly determine the absorbances of mL of pH 4.0 Citrate buffer, and the upper segment is a mixture this solution and of a Standard solution of USP Isoxsuprine Hy- prepared as directed under Assay preparation.
drochloride RS in the same medium having a known concentra- tion of about 50 µg per mL in 1-cm cells at the wavelengths of Assay preparation—Transfer an accurately measured volume maximum absorbance at about 269 and 300 nm, with a suita- of Injection, equivalent to about 4 mg of isoxsuprine hydrochlo- ble spectrophotometer, using water as the blank. Calculate the ride, to a 100-mL beaker, add 1 mL of dimethyl sulfoxide, and quantity, in mg, of C 18H23NO3 · HCl in the Isoxsuprine Hydro- allow to stand for about 10 minutes, with occasional swirling.
Add 1 mL of pH 4.0 Citrate buffer and 3 g of Solid Support, mix as directed under Chromatographic column, and transfer to the C(AU269 AU300) / (AS269AS300) column. Pass 75 mL of Mixed solvent through the column, and discard the eluate. Elute the column with a solution prepared in which C is the concentration, in µg per mL, of USP Isox- by mixing 0.2 mL of bis(2-ethylhexyl)phosphoric acid with 75 suprine Hydrochloride RS in the Standard solution; and the par- mL of Mixed solvent, and collect the eluate in a 125-mL Official from May 1, 2012Copyright (c) 2011 The United States Pharmacopeial Convention. All rights reserved.

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