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HOME >> API >> API List 2 >> Gabapentin

Gabapentin CAS number 60142-96-3

Gabapentin Molecular Weight 207.70, Formula C9H17NO2

Name : Gabapentin

Molecular Weight 207.70

Systematic (IUPAC) name

2-[1-(aminomethyl)cyclohexyl]acetic acid

Identifiers

CAS number 60142-96-3

ATC code N03AX12
PubChem 3446
DrugBank APRD00015

Chemical data

Formula C9H17NO2
Mol. mass 171.237 g/mol
Pharmacokinetic data
Bioavailability Rapid, in part by saturable carrier-mediated L-amino acid transport system
60% for 0.9 g daily to 27% for 4.8 g daily dose
Food increases absorption by 14%
Protein binding Less than 3%
Metabolism Not appreciably metabolized
Half life 5 to 7 hours
Excretion Renal

Specification For : Gabapentin
Test Specification
Description White to off white crystalline powder
Identification
A) Test A The IR spectrum of sample is concordant with the IR Spectrum of Gabapentin working std. Obtain in same manner
B) Test B Retention time of the major peak in the chromatogram of assay Preparation corresponds to that in the chromatogram of the std. Preparation as obtained in the assay
Solubility Soluble in water & 0.1N NaOH solution, sparingly soluble in methanol.
Residue on Ignition Limit : Max. 0.1% w/w
Heavy Metals Limit: Max.0.002 % w/w
Ph Limit : between 6.5 to 7.5
Chloride Related Substances (By HPLC) Limit : Max. 0.01% w/w
a) Impurity at RRt about 0.5 Limit : Max.0.1%
b) Gabapentin related compound A (Lactum) Limit : Max.0.1%
c) Individual impurity Limit : Max. 0.3%
d) Total impurity Limit : Max.0.5%
Water Content Limit: Max. 0.3% w/w
Organic Volatile Impurity & Residual Solvent Acetone : Max. 5000µg/g
Methanol : Max. 3000µg/g
Methylene Chloride : Max. 600µg/g
Assay by HPLC (On dried Basis) Limit: 99% to 101% w/w

Information Associated with Product:

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