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 98.5 percent and not more than 101.0 percent of C15H24N2 O2·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.
A: Ultraviolet Absorption 197U
Solution Prepare the test solution as follows. Dissolve about 50 mg, accurately weighed, in water to make 250.0 mL. Pipet 5 mL of this solution into a 100-mL volumetric flask, add 2 mL of Buffer No. 6, 10 Percent, pH 6.0 (see AntibioticsMicrobial Assays 81), then dilute with water to volume, and mix. For the purposes of this test, Buffer No. 6, 10 Percent, pH 6.0 does not have to be sterilized.
Absorptivities at 310 nm, calculated on the anhydrous basis, do not differ by more than 2.0%.
B: Dissolve 100 mg in 10 mL of water, and add 1 mL of potassium thiocyanate solution (1 in 4): a crystalline precipitate is formed. Recrystallize the precipitate from water, and dry at 80 for 2 hours: it melts between 130 and 132.
C: A solution of 100 mg in 5 mL of water meets the requirements of the tests for Chloride 191.
Water, Method I 921: not more than 2.0%.
Residue on ignition 281: not more than 0.1%.
Chromatographic purity Dissolve an accurately weighed quantity in water to obtain a test solution containing 50 mg per mL, and proceed as directed in the test for Chromatographic purity under 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 71 and for Bacterial endotoxins under 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 endotoxins under Tetracaine Hydrochloride for Injection.
Assay Transfer about 500 mg of Tetracaine Hydrochloride, accurately weighed, to a suitable vessel, add 5 mL of hydrochloric acid and 50 mL of water, and proceed as directed under Nitrite Titration 451, beginning with cool to 15. Each mL of 0.1 M sodium nitrite is equivalent to 30.08 mg of C15H24N2O2·HCl.
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USP32NF27 Page 3690Pharmacopeial Forum: Volume No. 31(2) Page 451