Gabapentin(Gabapentin hydrochloride)

Short Description:



Gabapentin(Gabapentin hydrochloride)
CAS Number: 60142-96-3
Molecular Formula: C9H17NO2
Standard: USP32
Package: 25kg/drum

Description:



Gabapentin(Gabapentin hydrochloride)
CAS Number: 60142-96-3
Molecular Formula: C9H17NO2
Standard: USP32
Package: 25kg/drum

ITEMS LIMIT
Appearance White crystalline powder
Identification A.      IR Spectrum should comply with the CRS
B.      HPLC-RT should comply with the CRS
pH 6.5~8.0
Water NMT 0.5%
Residue on ignition NMT 0.1%
Heavy Metals NMT 0.002%
Early eluting impurities Impurity A: NMT 0.1%
Impurity B: NMT 0.06%
Impurity E: NMT 0.10%
Impurity CDMA: NMT 0.10%
Max individual impurity: NMT 0.10%
Late eluting impurities Impurity D: NMT 0.10%
Impurity CAI: NMT 0.10%
Max individual impurity: NMT 0.1%
Total impurity (early and late) NMT 0.5%
Residual solvent Methanol: NMT 0.3%
Isopropanol: NMT 0.5%
Methylene chloride: NMT 0.06%
Toluene: NMT 0.089%
Assay (anhydrous basis) 98.0 ~ 102.0%
Note CDMA: 1,1-cyclohexane diacetic acid mono amide
CAI: 3,3-pentamethylene glutarimide

 


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