Doxycycline for Injection
» Doxycycline for Injection contains an amount of Doxycycline Hyclate equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of doxycycline (C22H24N2O8).
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1, protected from light.
USP Reference standards 11
USP Endotoxin RS
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Identification Dissolve a suitable quantity in methanol to obtain a solution containing the equivalent of 1 mg of doxycycline per mL, and filter. Using the filtrate as the Test Solution, proceed as directed for Method II under IdentificationTetracyclines 193.
Bacterial endotoxins 85 It contains not more than 1.14 USP Endotoxin Units per mg of doxycycline.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined, Fluid D being used instead of Fluid A.
pH 791: between 1.8 and 3.3, in the solution constituted as directed in the labeling.
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: the article containing added substances loses not more than 2.0% of its weight; the article containing no added substances loses not more than 4.0% of its weight.
Particulate matter 788: meets the requirements for small-volume injections.
Mobile phase, Diluent, Resolution solution, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Doxycycline Hyclate.
Assay preparation 1 (where it is represented as being in a single-dose container)Constitute Doxycycline for Injection as directed in the labeling. Withdraw all of the withdrawable contents, using a suitable hypodermic needle and syringe, and dilute quantitatively with Diluent to obtain a solution containing the equivalent of about 1000 µg of doxycycline per mL.
Assay preparation 2 (where the label states the quantity of doxycycline equivalent in a given volume of constituted solution)Constitute Doxycycline for Injection as directed in the labeling. Dilute an accurately measured volume of the constituted solution quantitatively with Diluent to obtain a solution containing the equivalent of about 1000 µg of doxycycline per mL.
Procedure Proceed as directed for Procedure in the Assay under Doxycycline Hyclate. Calculate the quantity, in mg, of doxycycline (C22H24N2O8) withdrawn from the container, or in the portion of constituted solution taken by the formula:
(L / D)(CP)(rU / rS)in which L is the labeled quantity, in mg, of doxycycline in the container, or in the volume of constituted solution taken, D is the concentration, in µg of doxycycline 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.
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USP35NF30 Page 2986