Pregabalin Lyrica Pharma Materials Gabapentin Chemical Replacement Anticonvulsant Antiepileptic

Pregabalin Lyrica Pharma Materials Gabapentin Chemical Replacement Anticonvulsant Antiepileptic
Pregabalin Lyrica Pharma Materials Gabapentin Chemical Replacement Anticonvulsant Antiepileptic

Product Name: Pregabalin
Synonyms: 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 name
“Lyrica”) 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.
The above information is edited by the chemicalbook of Tian Ye.

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
CAS No.
148553-50-8
Outer Packing
25KG
25KG
Production date
2016.6
Shelf life
2019.5
Standard adopted
Enterprise standard
Items of analysis
Specification
Results
Appearance
White or almost white powder
conforms
Identification
IRHPLC
IRandHPLC
conforms
Loss on drying
≤0.5%
≤0.5%
0.2%
0.2%
Specific Rotation
+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%
Assay(HPLC)
98%-101%
98%-101%
99.6%
99.6%
R-(HPLC)
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
Qualified

 

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