Oxytetracycline Hydrochloride
C22H24N2O9·HCl 496.90

2-Naphthacenecarboxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,6,10,12,12a-hexahydroxy-6-methyl-1,11-dioxo-,monohydrochloride,[4S-(4a,4aa,5a,5aa,6b,12aa)]-.
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,6,10,12,12a-hexahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride [2058-46-0].
»Oxytetracycline Hydrochloride has a potency equivalent to not less than 835µg of oxytetracycline (C22H24N2O9)per mg,calculated on the dried basis.
Packaging and storage— Preserve in tight,light-resistant containers.
Labeling— Where it is intended for use in preparing injectable or ophthalmic dosage forms,the label states that it is sterile or must be subjected to further processing during the preparation of injectable or ophthalmic dosage forms.
Identification—
Solution: 20µg per mL.
Medium: 0.1Nhydrochloric acid.
Absorptivity,calculated on the dried basis,at 353nm is between 88.2%and 96.8%of that of USP Oxytetracycline RS,the potency of the Reference Standard being taken into account.
B: To 1mg add 2mLof sulfuric acid:a light red color is produced.
Crystallinity á695ñ: meets the requirements.
pHá791ñ: between 2.0and 3.0,in a solution containing 10mg per mL.
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:it loses not more than 2.0%of its weight.
Other requirements— Where the label states that Oxytetracycline Hydrochloride is sterile,it meets the requirements for Sterilityand Bacterial endotoxinsunder Oxytetracycline for Injection.Where the label states that Oxytetracycline Hydrochloride must be subjected to further processing during the preparation of injectable dosage forms,it meets the requirements for Bacterial endotoxinsunder Oxytetracycline for Injection.Where it is intended for use in preparing ophthalmic dosage forms,it is exempt from the requirements for Bacterial endotoxins.
Assay—
Tetrabutylammonium hydrogen sulfate solution,Edetate disodium solution,pH7.5Phosphate buffer,Mobile phase,Standard preparation,System suitability solution,and Chromatographic system— Proceed as directed in the Assayunder Oxytetracycline.
Assay preparation— Transfer about 44mg of Oxytetracycline Hydrochloride to a 200-mLvolumetric flask,add about 25mLof 0.01Nhydrochloric acid,swirl to dissolve,dilute with 0.01Nhydrochloric acid to volume,and mix.
Procedure— Proceed as directed in the Assayunder Oxytetracycline.Calculate the quantity,in µg,of oxytetracycline (C22H24N2O9)in each mg of Oxytetracycline Hydrochloride taken by the formula:
200(CP/W)(rU/rS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1450
Phone Number:1-301-816-8335