Product Name: Pregabalin

Alias: Pregablin; (R)-Pregabalin; (S)-Pregabalin; 3-isobutyl GABA; (R-)-3-isobutyl GABA; 3-(aminomethyl)-5-methyl-(S)-Lyrica; 3-(aminomethyl)-5-methyl-hexanoic acid; 3(S)-(AMINOMETHYL)-5-METHYLHEXANOIC ACID; (3S)-3-(AMINOMETHYL)-5-METHYLHEXANOIC ACID; (3R)-3-(aminomethyl)-5-methylhexanoic acid; 3-(aminomethyl)-5-methyl-(3S)-Hexanoic acid; (S)(+)-3-Aminomethyl-5-methyl-hecanoic acid; (3S)-3-(aminomethyl)-5-methyl-hexanoic acid

CAS No.: 148553-50-8

EINECS No.: 604-639-1

Molecular Formula: C8H17NO2

Molecular Weight: 159.23

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:

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.