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Lamotrigine Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name LAMOTRIGINE CAS No: 84057- 84- 1

Batch No: LAM/ 011114 A. R. No 14/ FP/ LAM/ 0111

Date of Manufacture Nov- 2014 Date of Analysis 02- 11- 14

Batch Quantity 100 kg Date of Retest Jan- 2017

Sr. No Test Results Acceptance Criteria

1. Appearance Complies White to off white powder

2. Identification Complies IR

3. Loss on drying 0.20% NMT 0.25%

4. Sulphated ash 0.072% NMT 0.1%

5. Heavy metals Complies NMT 10 PPM

6. Related substances

Single impurity

Total impurities

0.06%

0.08%

NMT 0.5%

NMT 1.0%

7. Assay 99.45% 98.5% to 101.5%

Lamotrigine

Lamotrigine. svg

Lamotrigine 3d structure. png

Systematic ( IUPAC) name

6- ( 2, 3- dichlorophenyl) - 1, 2, 4- triazine- 3, 5- diamine

Clinical data

Trade names Lamictal

AHFS/ Drugs. com monograph

MedlinePlus a695007

Licence data US FDA: link

Pregnancy

category

AU: D

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 98%

Protein binding 55%

Metabolism Hepatic ( mostly UGT1A4- mediated)

Biological half- life 29 hours

Excretion Urine ( 65% ) , faeces ( 2% )

Identifiers

CAS Registry Number 84057- 84- 1 Yes

ATC code N03AX09

PubChem CID: 3878

IUPHAR/ BPS 2622

DrugBank DB00555

ChemSpider 3741 Yes

UNII U3H27498KS Yes

KEGG D00354 Yes

ChEBI CHEBI: 6367

ChEMBL CHEMBL741 Yes

Chemical data

Formula C9H7Cl2N5

Molecular mass 256.091 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 9, 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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