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.
Change to read:
Identification—
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
Antibiotics—Microbial 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.
USP29
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.
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 C
15H
24N
2O
2·HCl.
Auxiliary Information—
Staff Liaison :
Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 2093
Pharmacopeial Forum : Volume No. 31(2) Page 451
Phone Number : 1-301-816-8143
