SPL Set ID: ee7b9119-e88f-48ad-ae97-55e53374e62f

Pregabalin is described chemically as ( S )-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8 H 17 NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is: Pregabalin is a white to off-white, crystalline solid with a pKa 1 of 4.2 and a pKa 2 of 10.6. It is sparingly soluble in water and slightly soluble in methanol. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, USP, along with lactose monohydrate and talc as inactive ingredients. The capsule shells contain gelatin, iron oxide black (200 mg and 225 mg), iron oxide red (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) sodium lauryl sulfate and titanium dioxide. The imprinting black ink contains black iron oxide, butyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. chemical-structure