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Leflunomide Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Leflunomide CAS No: 75706- 12- 6

Batch No: LEF/ 011114 A. R. No 14/ FP/ LEF/ 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 or off- white crystalline powder

2. Identification Complies UV/ IR

3. Any other individual

impurity 0.067% NMT 0.1%

4. Total impurities 0.22% NMT 0.4%

5. Melting point 166ºC to 167ºC 164ºC to 168ºC

6. Heavy metals Complies NMT 20 PPM

7. Loss on drying 0.09% NMT 0.3%

8. Assay 99.84% 98% to 102%

.

Leflunomide

Leflunomide. svg

Leflunomide ball- and- stick. png

Systematic ( IUPAC) name

5- methyl- N- [ 4- ( trifluoromethyl) phenyl] - isoxazole- 4- carboxamide

Clinical data

Trade names Arava, Arabloc, Lunava, Repso, Elafra

AHFS/ Drugs. com monograph

MedlinePlus a600032

Licence data EMA: Link, US FDA: link

Pregnancy

category

AU: X ( High risk)

US: X ( Contraindicated)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral ( tablets)

Pharmacokinetic data

Bioavailability 80% [ 1]

Protein binding >99% [ 1]

Metabolism GI mucosa and liver[ 1]

Biological half- life 14–18 days[ 1]

Excretion Faeces ( 48% ) , urine ( 43% ) [ 1]

Identifiers

CAS Registry Number 75706- 12- 6 Yes

ATC code L04AA13

PubChem CID: 3899

IUPHAR/ BPS 6825

DrugBank DB01097 Yes

ChemSpider 3762 Yes

UNII G162GK9U4W Yes

KEGG D00749 Yes

ChEBI CHEBI: 6402 Yes

ChEMBL CHEMBL960 Yes

Chemical data

Formula C12H9F3N2O2

Molecular mass 270.207 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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