SPL Set ID: 8e78dc54-8322-435d-8879-4bfe37f1b98c

1 drug(s) with this SPL Set ID

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DOXYCYCLINE DOXYCYCLINE
40 mg Capsule
ALEMBIC PHARMACEUTICALS LIMITED FDA Rx Only

Doxycycline capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline pellets (24 mg immediate release and 16 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C 22 H 24 N 2 O 8 ). The structural formula of doxycycline, USP is: with an empirical formula of C 22 H 24 N 2 O 8 •H 2 O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water and in alcohol, practically insoluble in ether. It dissolves in dilute solutions of mineral acids and in solutions of alkali hydroxides and carbonates. Inert ingredients in the formulation are: Sugar spheres (composed of sucrose, corn starch and purified water), hypromellose, talc, polysorbate 80, methacrylic acid copolymer, triethyl citrate and FD&C Red No. 40 Aluminum Lake. Hard gelatin capsule shell contains iron oxide black, iron oxide red, iron oxide yellow, titanium dioxide and gelatin. The capsule shells are printed with edible black ink containing shellac, iron oxide black and potassium hydroxide. FDA approved dissolution test method and specifications differ from USP. doxycycline-str.jpg

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