SPL Set ID: b2b81bb6-5423-4221-8a61-f70a38d6a1e9

Pregabalin, USP 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, USP is: Pregabalin, USP is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin USP, along with pregelatinized starch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain iron oxide red and titanium dioxide and the white capsule shells contain titanium dioxide. Sodium Lauryl Sulfate (SLS) is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide and potassium hydroxide. prega-11-desc