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Gabapentine Manufacturing Thailand, the United Kingdom and USA
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Gabapentine

  • Product Name : Gabapentine
  • Grade : IP / BP / USP
  • Therapeutic Category : Anti convulsant
  • CAS No : 60142-96-3
  • Other Name : Neurontin
  • COA : Available
  • MSDS : Available

Description

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.

·         CAS: 60142-96-3

·         MW: 171.23

·         MF: C9H17NO2

·         Purity: 99%

·         Appearance: White crystalline powder

·         Other name: Neurontin

 

Specification:

 

Item

Specifications

Assay(on anhydrous basis)

≥98%

Appearance

White or almost white crystalline

powder

Identification A

The sample IR absorption spectrum

should match the reference standard

Identification B

The retention time of the major

peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation

pH

6.5 ~ 8.0

Loss on drying

≤0.5%

Ignition Residue

≤0.1%

Heavy metals

≤0.002 %

Related

compounds

Early eluting

Impurity E   ≤0.10%

   

Impurity A   ≤0.10%

   

Impurity B   ≤0.06%

   

Individual unknown impurity ≤0.10%

 

Late eluting

Impurity D  ≤0.10%

   

Individual Unknown impurity  ≤0.10%

 

Total impurities

≤0.50%

Residual solvents (Ethanol)

≤5000 ppm

  

Packaging details:

 

Packaging details:

25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum.

Storage:

Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat

Shelf Life:

5 years if sealed and store away from direct sun light.

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