Gabapentin Neurontin USP39 Pharma Materials Gabapentin Manufacturer

Gabapentin (Neurontin) Manufacturer
Product Name: Gabapentin
Synonyms:NEURONTIN;GABAPENTINE;GABAPENTIN;HYDROCHLORIDE;GABAPENTIN;GOE-3450;(1-AMINOMETHYL-CYCLOHEXYL)-ACETIC ACID;
1-(AMINOMETHYL)CYCLOHEXANEACETIC ACID;AKOS 92109
CAS: 60142-96-3
MF: C9H17NO2
MW: 171.24
EINECS: 262-076-3
Chemical Properties: White Crystalline Solid
Uses: Amino acid structurally related to γ-Aminobutyric Acid (GABA), designed to cross the  blood brain barrier. Used as an anticonvulsant. antipsychotic, 5HT2A antagonist. selective H1- receptor antagonist. For the treatment of adult Restless Legs Syndrome (RLS) and postherpetic  neuralgia (PHN).

Gabapentin (GPN), marketed under the brand name Neurontin among others, is a medication used to  treat epilepsy, neuropathic pain, hot flashes, and restless leg syndrome. In epilepsy it may be  used for those with partial seizures. It is recommended as one of a number of first line  medications for the treatment of neuropathic pain in diabetic neuropathy, post-herpetic  neuralgia, and central neuropathic pain. A 2017 review of its use for diabetic neuropathy and  postherpetic neuralgia found that about 15% of people have a meaningful benefit.

Gabapentin / Neurontin USP39 Pharma Materials Chemical Tests (COA) :

Test items
Items of analysis
Standard
Specification
Result
Results
appearance
white crystalline powder
white crystalline powder
identification
IR spectrum should comply with the CRS
HPLC-RT should comply with the CRS
conform
conform
PH
6.5-8.0
7.2
water
not more than 0.5%
0.0%
resiude on ignition
not more than 0.1%
0.0%
heavy metals
not more than 0.02%
less than 0.002%
impurity A
not more than 0.1%
<0.02%
impurity B
not more than 0.06%
<0.02%
impurity E
not more than 0.1%
<0.02%
impurity CDMA
not more than 0.1%
<0.02%
max individual unknown impurity
not more than 0.1%
<0.03%
impurity D
not more than 0.1%
<0.02%
impurity CAI
not more than 0.1%
<0.02%
max individual unknown impurity
not more than 0.1%
<0.02%
total impurity
not more than 0.5%
0.0%
methanol
not more than 3000ppm
55ppm
isopropanol
not more than 5000ppm
52ppm
methylene chloride
not more than 600ppm
N.D
toluene
not more than 890ppm
N.D
assay
98.0%~102.0%
99.4%
Conclusion
Conclusion
Qualified
Qualified

 

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