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Details
- Synonyms – (S)-3-(Aminomethyl)-5-methylhexanoic Acid
- Cas Number – 148553-50-8
- Mol. Formula – C8h17no2
- Mol. Weight – 159.22
- It Is White To Off-white Crystalline Powder With Its Melting Range Of 186° C To 188° C. It Is Freely Soluble In Water And Both Basic And Acidic Solutions.
- Standard – Offered Of Pharmaceutical Grade BP/USP/EP
- Packing – Offered In Export Worthy Packing Of 25 Kilos Or As Per Our Customer Requirements.
Pregabalin Is An Anticonvulsant And Neuropathic Pain Agent. It Is Thought To Bind To Certain Areas In The Brain That Help Reduce Seizures, Nerve Pain, And Anxiety. Treating Fibromyalgia Or Nerve Pain Caused By Certain Conditions (Eg, Shingles, Diabetic Nerve Problems, Spinal Cord Injury). It Is Also Used In Combination With Other Medicines To Treat Certain Types Of Seizures. Pregabalin Is A Lipophilic Gaba Analog/ligand At Α2δ Subunit Of Voltage-dependent Ca2+ Channels. Pregabalin Is An Anticonvulsant, Anxiolytic Analgesic Used To Treat Peripheral Neuropathic Pain. Pregabalin Is A Gamma-aminobutyric Acid Analog Anticonvulsant And Analgesic Used For Neuropathic Pain And As An Add On Therapy For Partial Seizures With Or Without Secondary Generalization In Adults. This Medication Is Used To Treat Pain Caused By Nerve Damage Due To Diabetes Or Toshingles (Herpes Zoster) Infection.
Certificate of analysis
Tests |
SPECIFICATIONS |
RESULTS |
Appearance |
Off-white to white powder |
White powder |
Identification |
The infrared absorption spectrum of the sample should concordant with that of the spectrum of working standard of product |
Conforms |
Solubility |
Sparingly soluble in water |
Conforms |
Specific Optical
Rotation (On anhydrous basis)(°) |
+10.0° ~ +12.0° |
+10.0° |
Loss on drying( w/w) |
≤0.5% |
0.32% |
Sulphate ash |
≤0.1% |
0.05% |
Heavy Metals(%) |
≤20ppm |
Conforms |
Enantiomeric purity |
The area of peak due to R-Pregabalin is not more than 0.5 % the area of the S-Pregabalin. |
Conforms |
Purity by HPLC |
Lactam impurities ≤0.5% |
Not detected |
Individual impurities ≤0.5% |
0.437% |
Total impurities ≤1.0% |
0.4% |
Purity≥99% |
99.6% |
Assay(%) |
98%~102.0%
It content not less than 98.0% and not more than 102.0% on dried basis. |
99.95% |
Common Name |
API Pregabalin Powder |
CAS Number |
148553-50-8 |
Molecular Weight |
159.226 |
Density |
1.0±0.1 g/cm3 |
Boiling Point |
274.0±23.0 °C at 760 mmHg |
Molecular Formula |
C8H17NO2 |
Melting Point |
194-196ºC |
Exterior |
White powder |
Flash Point |
119.5±22.6 °C |