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Pregabalin Lyrica Pharma Ingredient Gabapentin Replacement Anticonvulsant Antiepileptic

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Pregabalin Pure Powder, API of Lyrica

Nom du produit: Pregabalin
Synonymes: Lyrica, 3(S)-(AMINOMETHYL)-5-METHYLHEXANOIC ACID;(3S)-3-(AMINOMETHYL)-5-METHYLHEXANOIC ACID;PREGABALIN;Pregablin;3-(Aminomethyl)-5-methyl-hexanoic acid;PREDNISOLONESODIUMPHOSPHATE;(R)-Pregabalin;(S)-Pregabalin
CAS: 148553-50-8
MF: C8H17NO2
MW: 159.23
EINECS: 200-659-6
Chemical Properties Off-White Solid
Melting point 194-196°C
Uses new antiepileptic drugs

Pregabalin Usage And Synthesis
Antiepileptic drus and therapeutic drugs for neuropathic pain. Pregabalin is a new
antiepileptic drug, having a γ-amino butyric acid structure on its molecular structure, which has anticonvulsant effects, and is successfully developed by the company Pfizer for the treatment of peripheral neuropathic pain, or adjuvant treatment of partial seizures.
In December 2008, the US Food and Drug Administration (FDA) approved pregabalin (trade nameLyrica”) for the treatment of diabetic peripheral neuropathic pain (DPN) and postherpetic neuralgia (PHN)which are Both the most common neuropathic pains.
Neuropathic pain is one of the most difficult chronic pain syndromes to treat , dull pain,burning, tingling as the main feature, there are a lot of incentives of neuralgia, diabetes,infections (such as herpes zoster), cancer and AIDS, etc.. can cause neurological pain, in Europe about 3% of the population suffer from neuralgia torture.

Uses S-Enantiomer of Pregabalin. A GABA analogue used as an anticonvulsant. Anxiolytic analgesic used to treat peripheral neuropathic pain and fibromyalgia.
Uses Pregabalin is an anticonvulsant drug used for neuropathic pain, as an adjunct therapy for partial seizures, and in generalized anxiety disorder. It was designed as a more potent successor to gabapentin.

Pregabalin / Lyrica Pharma Materials Chemical Tests (COA) :

Product name
Pregabalin
CAS
n ° CAS.
148553-50-8
Outer Packing
25KG
25KG
Date de production
2016.6
Durée de conservation
2019.5
Norme adoptée
Norme d'entreprise
Éléments d'analyse
spécification
Résultats
Apparence
White or almost white powder
conforms
Identification
IRHPLC
IRandHPLC
conforms
Perte au séchage
≤0,5%
≤0,5%
0.2%
0.2%
Rotation spécifique
+10°~+12°
+10°~+12°
+10.77°
+10.77°
Residue on ignition
≤0.1%
≤0.1%
0.08%
0.08%
Heavy metals
≤20ppm
≤20ppm
conforms
C
impurity C
≤0.1%
≤0.1%
conforms
Any impurity
≤0.1%
≤0.1%
0.044%
0.044%
Total impurity
≤1.0%
≤1.0%
0.14%
0.14%
Essai(CLHP)
98%-101%
98%-101%
99.6%
99.6%
R-(CLHP)
R-isomer
≤0.15%
≤0.15%
0.033%
0.033%
()
Bromide cintent(Titrmetry)
≤500ppm
≤500ppm
26ppm
26ppm
Ethanol
≤5000ppm
≤5000ppm
conforms
Isopropyl alcohol
≤5000ppm
≤5000ppm
142ppm
142ppm
≤5000ppm
≤5000ppm
conforms
≤60ppm
≤60ppm
conforms
Conclusion
Qualifié

 

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