Doxycycline for Injection
»Doxycycline for Injection contains an amount of Doxycycline Hyclate equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of doxycycline (C22H24N2O8).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ,protected from light.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Identification— Dissolve a suitable quantity in methanol to obtain a solution containing the equivalent of 1mg of doxycycline per mL,and filter.Using the filtrate as the Test Solution,proceed as directed for Method IIunder Identification—Tetracyclines á193ñ.
Bacterial endotoxins á85ñ— It contains not more than 1.14USP Endotoxin Units per mg of doxycycline.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined,Fluid Dbeing used instead of Fluid A.
pHá791ñ: between 1.8and 3.3,in the solution constituted as directed in the labeling.
Loss on drying á731ñ— Dry about 100mg,accurately weighed,in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5mm of mercury at 60for 3hours: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 á788ñ: meets the requirements for small-volume injections.
Assay—
Mobile phase,Diluent,Resolution solution,Standard preparation,andChromatographic system— Proceed as directed in the Assayunder 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 Diluentto obtain a solution containing the equivalent of about 1000µg 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 Diluentto obtain a solution containing the equivalent of about 1000µg of doxycycline per mL.
Procedure— Proceed as directed for Procedurein the Assayunder Doxycycline Hyclate.Calculate the quantity,in mg,of doxycycline (C22H24N2O8)withdrawn from the container,or in the portion of constituted solution taken by the formula: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 Lis the labeled quantity,in mg,of doxycycline in the container,or in the volume of constituted solution taken,Dis the concentration,in µg of doxycycline per mL,of Assay preparation 1or 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.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 701
Phone Number:1-301-816-8335