USP Monographs: Methotrimeprazine

Methotrimeprazine

C19H24N2OS

328.47

10H-Phenothiazine-10-propanamine, 2-methoxy-N,N,

-trimethyl-, (

)-.
(

)-10-[3-(Dimethylamino)-2-methylpropyl]-2-methoxyphenothiazine

[60-99-1].

» Methotrimeprazine contains not less than 98.0 percent and not more than 101.0 percent of C19H24N2OS, calculated on the dried basis.

Packaging and storage— Preserve in well-closed, light-resistant containers. Store at 25

, excursions permitted between 15

and 30

USP Reference standards

— USP Methotrimeprazine RS.

NOTE—Throughout the following procedures, protect test or assay specimens, the USP Reference Standard, and the solutions containing them, by conducting the procedures without delay, under subdued light, or using low-actinic glassware.

Identification—

A: Infrared Absorption

197K

B: Ultraviolet Absorption

197U

—

Solution: 7 µg per mL.

Medium: alcohol.

Absorptivities at 255 nm, calculated on the dried basis, do not differ by more than 3.0%.

Specific rotation

781S

: between

and

Test solution: 50 mg per mL, in chloroform.

Loss on drying

731

— Dry it at 100

for 3 hours: it loses not more than 0.5% of its weight.

Selenium

291

— The absorbance of the solution from the Test Solution, prepared with 100 mg of Methotrimeprazine and 100 mg of magnesium oxide, is not greater than one-half that from the Standard Solution (0.003%).

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

Assay— Dissolve about 700 mg of Methotrimeprazine, accurately weighed, in 100 mL of chloroform, add 1 drop of a 1 in 500 solution of crystal violet in chloroform, and titrate with 0.1 N perchloric acid VS to the first disappearance of the violet tinge. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 32.85 mg of C19H24N2OS.

Auxiliary Information— Staff Liaison : Clydewyn M. Anthony, Ph.D., Scientist

Expert Committee : (MDCCA05) Monograph Development-Cough Cold and Analgesics

USP29–NF24 Page 1385

Pharmacopeial Forum : Volume No. 29(6) Page 1931

Phone Number : 1-301-816-8139


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