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Tetracaine Hydrochloride for Injection
» Tetracaine Hydrochloride for Injection contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of tetracaine hydrochloride (C15H24N2O2·HCl).
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1, preferably of Type I glass.
Completeness of solution 641— A 10-mg portion dissolves in 1 mL of water in not more than 2 seconds to yield a colorless solution free from undissolved solid.
Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Identification—
Solution: the solution employed for measurement of absorbance in the Assay.
B: It responds to Identification test B under Tetracaine Hydrochloride.
Bacterial endotoxins 85— It contains not more than 0.7 USP Endotoxin Unit per mg of tetracaine hydrochloride.
Uniformity of dosage units 905: it meets the requirements employing the following method.
Standard preparation— Prepare as directed in the Assay under Tetracaine Hydrochloride in Dextrose Injection.
Test preparation— Transfer the contents of one container, with the aid of water, to a 200-mL volumetric flask, add water to volume, and mix. Pipet a portion of this solution, equivalent to about 1 mg of tetracaine hydrochloride, to a 100-mL volumetric flask, add 5 mL of dilute hydrochloric acid (1 in 200) and 10 mL of Buffer No. 6, 10 percent, pH 6.0 (see Phosphate Buffers and Other Solutions under Antibiotics— Microbial Assays 81), add water to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay, except to use the Test preparation instead of the Assay preparation.
Calculate the quantity, in mg, of C15H24N2O2·HCl in each container taken by the formula:
20(C / V)(AU / AS)
in which V is the volume, in mL, of the portion used in the Test preparation, AU is the absorbance of the Test preparation, and C and AS are as defined in the Assay.
pH 791: between 5.0 and 6.0, in a solution (1 in 100).
Water, Method I 921: not more than 2.0%.
Residue on ignition— Weigh accurately about 500 mg, transfer to a beaker, and dissolve in 10 mL of methanol. Filter through paper previously washed with methanol, collecting the filtrate in an ignited and tared crucible and washing the beaker and the filter paper with 25 mL to 30 mL of methanol. Evaporate with the aid of heat and a current of air to dryness, and proceed as directed under Residue on Ignition 281, beginning with “Heat, gently at first.” Not more than 0.1% of residue is found.
Chromatographic purity— Dissolve an accurately weighed quantity of Tetracaine Hydrochloride for Injection 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— It meets the requirements for Sterility Tests 71 and Labeling under Injections 1.
Assay—
Standard preparation— Prepare as directed in the Assay under Tetracaine Hydrochloride in Dextrose Injection.
Assay preparation— Transfer to a tared 20-mL beaker the contents of a sufficient number of containers of Tetracaine Hydrochloride for Injection to yield about 100 mg of tetracaine hydrochloride. Weigh immediately, and transfer with the aid of water to a 500-mL volumetric flask. Add water to volume, and mix. Transfer 5.0 mL to a 100-mL volumetric flask, add 5 mL of dilute hydrochloric acid (1 in 200) and 10 mL of Buffer No. 6, 10 percent, pH 6.0 (see Phosphate Buffers 81), then add water to volume, and mix.
Procedure— Concomitantly determine the absorbances of the Assay preparation and the Standard preparation at the wavelength of maximum absorbance at about 310 nm, with a suitable spectrophotometer, using water as the blank. Calculate the quantity, in mg, of C15H24N2O2·HCl in the portion of Tetracaine Hydrochloride for Injection taken by the formula:
10C(AU / AS)
in which C is the concentration, in µg per mL, of USP Tetracaine Hydrochloride RS in the Standard preparation, and AU and AS are the absorbances of the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Senior Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP31–NF26 Page 3357
Phone Number : 1-301-816-8143