Pregabalin
Brief Introduction:
Pregabalin, the chemical name is: (S)(+)-3-Aminomethyl-5-methyl-hecanoic acid, the molecular formula is: C8H17NO2, is an anti-epileptic drug, mainly used for the clinical treatment of post-herpetic neuralgia.
Specifications of our Pregabalin:
| Test Items | Specifications | |
| Appearance | White or almost white powder | |
| Solubility | Sparingly soluble in water, very slightly soluble in methanol, practically insoluble in heptane | |
| Identification | A: IR | IR spectrum is accordant with that of reference standard |
| B: HPLC | The principal peak in the chromatogram obtained with the test solution is similar in retention time to the principal peak in the chromatogram obtained with the reference solution in the Enantiomeric purity | |
| Water | Not more than 0.5% | |
| Sulfated Ash | Not more than 0.1% | |
| Related Substances | Impurity A | Not more than 0.15% |
| Impurity C | Not more than 0.10% | |
| Impurity D | Not more than 0.10% | |
| Unspecified impurity | Not more than 0.10% | |
| Total impurities | Not more than 0.50% | |
| Enantiomeric purity (Impurity B) | Not more than 0.15% | |
| Residual Solvents | Ethanol | Not more than 5000 ppm |
| 2-Propanol | Not more than 5000 ppm | |
| Tert-Butylmethyl ether | Not more than 5000 ppm | |
| Ethyl acetate | Not more than 5000 ppm | |
| Tetrahydrofuran | Not more than 720 ppm | |
| Toluene | Not more than 890 ppm | |
| Assay (Calculated on the anhydrous basis) | 98.0% ~ 102.0% | |
Indications:
1. Neuralgia caused by diabetic peripheral neuropathy and post-herpetic neuralgia;
2. Adjuvant treatment of partial seizures of epilepsy;
3. It can also be used for anxiety, social phobia, arthritis, etc.
Packaging:
1kg/Aluminum Foil Bag, 25kg/Fibre Drum or according to the specific requirements from customers.
Storage Conditions:
Preserved in unopened original containers in a cool dry place before using; kept away from direct sunlight, heat and moisture.
Shelf Life:
36 months if stored under above mentioned conditions.
