Pregabalin Lyrica Pharma Ingredient Gabapentin Replacement Anticonvulsant Antiepileptic Chemical Supplier
Pregabalin Pure Powder, API of Lyrica
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.
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) :
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Product name
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Pregabalin
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CAS
CAS No.
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148553-50-8
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Outer Packing
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25KG
25KG
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Production date
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2016.6
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Shelf life
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2019.5
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Standard adopted
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Enterprise standard
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Items of analysis
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Specification
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Results
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Appearance
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White or almost white powder
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conforms
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Identification
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IRHPLC
IRandHPLC
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conforms
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Loss on drying
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≤0.5%
≤0.5%
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0.2%
0.2%
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Specific Rotation
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+10°~+12°
+10°~+12°
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+10.77°
+10.77°
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Residue on ignition
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≤0.1%
≤0.1%
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0.08%
0.08%
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Heavy metals
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≤20ppm
≤20ppm
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conforms
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C
impurity C
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≤0.1%
≤0.1%
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conforms
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Any impurity
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≤0.1%
≤0.1%
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0.044%
0.044%
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Total impurity
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≤1.0%
≤1.0%
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0.14%
0.14%
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Assay(HPLC)
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98%-101%
98%-101%
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99.6%
99.6%
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R-(HPLC)
R-isomer
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≤0.15%
≤0.15%
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0.033%
0.033%
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()
Bromide cintent(Titrmetry)
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≤500ppm
≤500ppm
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26ppm
26ppm
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Ethanol
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≤5000ppm
≤5000ppm
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conforms
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Isopropyl alcohol
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≤5000ppm
≤5000ppm
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142ppm
142ppm
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≤5000ppm
≤5000ppm
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conforms
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≤60ppm
≤60ppm
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conforms
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Conclusion
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Qualified
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