Tetracaine Hydrochloride
C15H24N2O2·HCl
300.82
Benzoic acid,4-(butylamino)-,2-(dimethylamino)ethyl ester,monohydrochloride.
2-(Dimethylamino)ethyl p-(butylamino)benzoate monohydrochloride [136-47-0].
»Tetracaine Hydrochloride contains not less than 98.5percent and not more than 101.0percent of C15H24N2O2·HCl,calculated on the anhydrous basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
Labeling—
Where it is intended for use in preparing injectable dosage forms,the label states that it is sterile or must be subjected to further processing during the preparation of injectable or other sterile dosage forms.
Identification—
Solution—
Prepare the test solution as follows.Dissolve about 50mg,accurately weighed,in water to make 250.0mL.Pipet 5mLof this solution into a 100-mLvolumetric flask,add 2mLof Buffer No.6,10percent,pH6.0(see Phosphate Buffers á81ñ),then dilute with water to volume,and mix.
Absorptivities at 310nm,calculated on the anhydrous basis,do not differ by more than 2.0%.
B:
Dissolve 100mg in 10mLof water,and add 1mLof potassium thiocyanate solution (1in 4):a crystalline precipitate is formed.Recrystallize the precipitate from water,and dry at 80
for 2hours:it melts between 130and 132.
for 2hours:it melts between 130and 132.
C:
Asolution of 100mg in 5mLof water responds to the tests for Chloride á191ñ.
Water,Method Iá921ñ:
not more than 2.0%.
Residue on ignition á281ñ:
not more than 0.1%.
Chromatographic purity—
Dissolve an accurately weighed quantity in water to obtain a test solution containing 50mg per mL,and proceed as directed in the test for Chromatographic purityunder Tetracaine,beginning with “Prepare a Standard solution.”
Other requirements—
Where the label states that Tetracaine Hydrochloride is sterile,it meets the requirements for Sterility Tests á71ñand for Bacterial endotoxinsunder Tetracaine Hydrochloride for Injection.Where the label states that Tetracaine Hydrochloride must be subjected to further processing during the preparation of injectable or other sterile dosage forms,it meets the requirements for Bacterial endotoxinsunder Tetracaine Hydrochloride for Injection.
Assay—
Transfer about 500mg of Tetracaine Hydrochloride,accurately weighed,to a suitable vessel,add 5mLof hydrochloric acid and 50mLof water,and proceed as directed under Nitrite Titration á451ñ,beginning with “cool to 15.”Each mLof 0.1Msodium nitrite is equivalent to 30.08mg of C15H24N2O2·HCl.
.”Each mLof 0.1Msodium nitrite is equivalent to 30.08mg of C15H24N2O2·HCl.
Auxiliary Information—
Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1881
Pharmacopeial Forum:Volume No.29(5)Page 1586
Phone Number:1-301-816-8379