Methdilazine Hydrochloride
C18H20N2S·HCl
332.89
10H-Phenothiazine,10-[(1-methyl-3-pyrrolidinyl)methyl]-,monohydrochloride.
10-[(1-Methyl-3-pyrrolidinyl)methyl]phenothiazine monohydrochloride [1229-35-2].
»Methdilazine Hydrochloride contains not less than 97.0percent and not more than 103.0percent of C18H20N2S·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
USP Reference standards á11ñ—
USP Methdilazine 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:
Infrared Absorption á197Kñ.
B:
Ultraviolet Absorption á197Uñ—
Solution:
5µg per mL.
Medium:
water.
C:
Asolution of it responds to the tests for Chloride á191ñ.
pHá791ñ:
between 4.8and 6.0,in a solution (1in 100).
Loss on drying á731ñ—
Dry it in vacuum at 65
for 16hours:it loses not more than 1.0%of its weight.
for 16hours:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ:
not more than 0.5%.
Selenium á291ñ—
The absorbance of the solution from the Test Solution,prepared with 100mg of Methdilazine Hydrochloride and 100mg of magnesium oxide,is not greater than one-half that from the Standard Solution(0.003%).
Heavy metals,Method IIá231ñ:
0.002%.
Ordinary impurities á466ñ—
Test solution:
methanol.
Standard solution:
methanol.
Application volume:
10µL.
Eluant:
a mixture of toluene,isopropyl alcohol,and ammonium hydroxide (70:29:1),in a nonequilibrated chamber.
Visualization:
5.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Transfer about 100mg of Methdilazine Hydrochloride,accurately weighed,to a 1000-mLvolumetric flask,add water to volume,and mix.Transfer 5.0mLof this solution to a 100-mLvolumetric flask,dilute with water to volume,and mix.Concomitantly determine the absorbances of this solution and of a Standard solution of USP Methdilazine Hydrochloride RSin the same medium having a known concentration of about 5µg per mL,in 1-cm cells at 252and 275nm,with a suitable spectrophotometer,using water as the blank.Calculate the quantity,in mg,of C18H20N2S·HCl in the portion of Methdilazine Hydrochloride taken by the formula:
20C(A252-A275)U/(A252-A275)S,
in which Cis the concentration,in µg per mL,of USP Methdilazine Hydrochloride RSin the Standard solution;and the parenthetic expressions are the differences in the absorbances of the two solutions at the wavelengths indicated by the subscripts,for the solution of Methdilazine Hydrochloride (U)and the Standard solution (S),respectively.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 1238
Phone Number:1-301-816-8389