Packaging and storage—
Preserve in
Containers for Sterile Solids as described under
Injections 
1
, protected from light.
Labeling—
Label Tetracycline Hydrochloride for Injection that contains an anesthetic agent to indicate that it is intended for intramuscular administration only.
Constituted solution—
At the time of use, it meets the requirements for
Constituted Solutions under
Injections 1.
Identification—
The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for tetracycline, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay.
pH 791:
between 2.0 and 3.0, in a solution containing 10 mg per mL.
Loss on drying 731—
Dry about 100 mg, accurately weighed, in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60
for 3 hours: it loses not more than 5.0% of its weight.
Limit of 4-epianhydrotetracycline—
Using the
Diluting solvent,
Chromatographic system, and
Procedure set forth in the
Assay, chromatograph a Standard solution prepared by dissolving an accurately weighed quantity of
USP 4-Epianhydrotetracycline Hydrochloride RS in
Diluting solvent to obtain a solution having a known concentration of about 15 µg per mL. Using the chromatogram so obtained and the chromatogram of the
Assay preparation obtained as directed in the
Assay, calculate the percentage of 4-epianhydrotetracycline hydrochloride in the Tetracycline Hydrochloride for Injection taken by the formula:
(10CE / T)(rU / rS),
in which
CE is the concentration, in µg per mL, of
USP 4-Epianhydrotetracycline Hydrochloride RS in the Standard solution;
T is the quantity, in mg, of tetracycline hydrochloride in the portion of Tetracycline Hydrochloride for Injection taken to prepare the
Assay preparation, based on the labeled quantity; and
rU and
rS are the 4-epianhydrotetracycline peak responses obtained from the
Assay preparation and the Standard solution, respectively: not more than 3.0% is found.
Assay—
Diluting solvent, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system
—Prepare as directed in the
Assay under
Tetracycline Hydrochloride.
Assay preparation 1
(where it is represented as being in a single-dose container)—Constitute Tetracycline Hydrochloride for Injection as directed in the labeling. Withdraw all of the withdrawable contents, using a suitable hypodermic needle and syringe, and dilute quantitatively and stepwise with Diluting solvent to obtain a solution containing about 0.5 mg of tetracycline hydrochloride per mL.
Assay preparation 2
(where the label states the quantity of tetracycline hydrochloride in a given volume of constituted solution)—Constitute Tetracycline Hydrochloride for Injection as directed in the labeling. Dilute an accurately measured volume of the constituted solution quantitatively with Diluting solvent to obtain a solution containing about 0.5 mg of tetracycline hydrochloride per mL.
Procedure—
Proceed as directed in the
Assay under
Tetracycline Hydrochloride. Calculate the quantity, in mg, of C
22H
24N
2 O
8.HCl withdrawn from the container, or in the portion of constituted solution taken by the formula:
(L / D)(CP / 1000)(rU / rS),
in which
L is the labeled quantity, in mg, of C
22H
24N
2O
8.HCl in the container, or in the volume of constituted solution taken;
D is the concentration, in mg of tetracycline hydrochloride per mL, of
Assay preparation 1 or
Assay preparation 2, based on the labeled quantity in the container or in the portion of constituted solution taken, respectively, and the extent of dilution; and the other terms are as defined therein.
