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Gabapentin Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Gabapentin USP CAS No: 60142- 96- 3

Batch No: GAB/ 030313 A. R. No 13/ FP/ GAB/ 0303

Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

Batch Quantity 165 kg Date of Retest Jan- 2016

Sr. No Test Results Acceptance Criteria

1. Appearance

2. Solubility

3. Identification

Complies a) By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

Complies b) By HPLC: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.

4. pH 7.1 Between 6.5–8.0

5. Heavy Metals Complies 20ppm

6. Water Content by KF 0.18% NMT 0.5%

7. Residue On Ignition 0.035% NMT 0.1%

8. Assay HPLC 98.85% 98.0% –102.0

. .

Gabapentin

Gabapentin2DACS. svg

Gabapentin 3D. png

Systematic ( IUPAC) name

1- ( aminomethyl) cyclohexaneacetic acid

Clinical data

Trade names Neurontin, Gabarone, Gralise

AHFS/ Drugs. com monograph

MedlinePlus a694007

Licence data US Daily Med: link

Pregnancy

category

AU: B1

US: C ( Risk not ruled out)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 27- 60% ( inversely proportional to dose; a high fat meal also increases bioavailability) [ 1] [ 2]

Protein binding Less than 3% [ 1] [ 2]

Metabolism Not significantly metabolised[ 1] [ 2]

Biological half- life 5 to 7 hours[ 1] [ 2]

Excretion Renal[ 1] [ 2]

Identifiers

CAS Registry Number 60142- 96- 3 Yes

ATC code N03AX12

PubChem CID: 3446

DrugBank DB00996 Yes

ChemSpider 3328 Yes

UNII 6CW7F3G59X Yes

KEGG D00332 Yes

ChEBI CHEBI: 42797 Yes

ChEMBL CHEMBL940 Yes

PDB ligand ID GBN ( PDBe, RCSB PDB)

Chemical data

Formula C9H17NO2

Molecular mass 171.237 g/ mol


Company Contact:


  • Phone: 912406641875

  • Address: PLOT NO: 04 JALGAON ROAD, HARSOOL, AURANGABAD, India

  • Email: Email


Published date: September 8, 2015 -

  • Business Description: We, at SWAPNROOP, are committed to providing affordable Drugs &

    Pharmaceuticals of global quality standards to Pharma Companies all over

    the world. In our warehouse facilities, approved by FDA. we supply

    Pharmaceutical Finished products, Dental products and Active

    Pharmaceutical Ingredients.

    We, at SWAPNROOP, are committed to providing affordable Drugs & Pharmaceuticals of global quality standards to Pharma Companies all over the world. Our warehouse facilities is approved by FDA and we are specializes in sales and marketing of Pharmaceutical Finished products, Pharmaceutical Active Ingredients (API's) and Dental products, providing a wide range of quality and affordable products to a large number of pharmaceutical companies, reputed private and government/semi government organizations/ research centers as well as universities.

    We supply and market over 500 molecules and their combinations in multiple dosage forms, catering to patient needs in various therapies. These include Anti infectives, Cardiovascular, Pain management, Central Nervous System (CNS), Gastrointestinal, Respiratory, Dermatology, Orthopaedics, Nutritionals, Urology and Dental.

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