99% Oral Hypoglycemic Agents,
Oral Hypoglycemic Agents CAS 148553-50-8,
CAS 148553-50-8 Pregabalin Lyrica Powder
Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23.
Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 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.
LYRICA (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, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.
How to use
LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.
|Appearance||A white to off white powder||White powder|
|Identification||A. Meets the requirement||Complies|
|B. IR: similar to Reference Substance||Complies|
|Loss on drying||≤0.5%||0.21%|
|Related Substances||Any single impurity ≤0.1%
Total impurity ≤0.8%
|Purity By HPLC R-isomer||≤0.15%||0.10|
|Residue on ignition||≤0.1%||0.05%|
|Residual solvents||Isopropyl alcohol ≤5000ppm
Ethyl Acetate ≤5000ppm
|Conclusion||Analyse according to Factory Standard , Conform|
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