SPL Set ID: ecab983e-6ed8-4440-b7b4-7ac4bf39b26c

Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate, USP with the HMG-CoA-reductase inhibitor atorvastatin calcium, USP. Amlodipine besylate, USP is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro­ 6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20 H 25 ClN 2 O 5 •C 6 H 6 O 3 S. Atorvastatin calcium, USP is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl­4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. Its empirical formula is (C 33 H 34 FN 2 O 5 ) 2 Ca•3H 2 O. The structural formulae for amlodipine besylate, USP and atorvastatin calcium, USP are shown below. Amlodipine besylate Atorvastatin calcium Amlodipine and atorvastatin tablets, USP contain amlodipine besylate, USP, a white or almost white powder, and atorvastatin calcium, USP, a white to off-white powder. Amlodipine besylate, USP has a molecular weight of 567.1 and atorvastatin calcium, USP has a molecular weight of 1209.42. Amlodipine besylate, USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in 2-propanol and in water. Atorvastatin calcium, USP is freely soluble in methanol, slightly soluble in ethanol, very slightly soluble in water and in pH 7.4 phosphate buffer, insoluble in aqueous solution of pH 4 and in acetonitrile. Amlodipine and atorvastatin tablets, USP are available as film-coated tablets for oral administration containing: • 2.5 mg amlodipine equivalent to 3.5 mg amlodipine besylate, USP and 10 mg atorvastatin equivalent to 10.3 mg atorvastatin calcium, USP. • 2.5 mg amlodipine equivalent to 3.5 mg amlodipine besylate, USP and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium, USP. • 2.5 mg amlodipine equivalent to 3.5 mg amlodipine besylate, USP and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium, USP. • 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate, USP and 10 mg atorvastatin equivalent to 10.3 mg atorvastatin calcium, USP. • 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate, USP and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium, USP. • 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate, USP and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium, USP. • 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate, USP and 80 mg atorvastatin equivalent to 82.7 mg atorvastatin calcium, USP. • 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate, USP and 10 mg atorvastatin equivalent to 10.3 mg atorvastatin calcium, USP. • 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate, USP and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium, USP. • 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate, USP and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium, USP. • 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate, USP and 80 mg atorvastatin equivalent to 82.7 mg atorvastatin calcium, USP. Each film-coated tablet also contains calcium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3000, polysorbate 80, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. Additionally 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg also contains FD&C Blue #2 Aluminum Lake. Amlodipine and atorvastatin tablets, USP meets USP Dissolution Test 2 . amloatorva-amlodipine.jpg amloatorva-atorvastatin.jpg