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Fesoterodine Fumarate Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Fesoterodine Fumarate CAS No: 286930- 03- 8

Batch No: FES/ 011114 A. R. No 14/ FP/ FES/ 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 solid

2. IDENTIFICATION Complies The retention time of the major peak in the chromatogram corresponds to that in the chromatogram of standard preparation

3. Solubility Complies Soluble in ethanol 、 methanol 、 and water

4. Loss on drying 0.18% NMT 1.0%

5. Residue on ignition 0.05% NMT 0.2%

6. Heavy metals Complies NMT 20 PPM

7. Purity 97.21% NLT 97.0%

.

Fesoterodine

Fesoterodine. svg

Space- filling model of the fesoterodine molecule

Systematic ( IUPAC) name

[ 2- [ ( 1R) - 3- ( Di( propan- 2- yl) amino) - 1- phenylpropyl] - 4- ( hydroxymethyl) phenyl] 2- methylpropanoate

Clinical data

Trade names Toviaz

AHFS/ Drugs. com monograph

MedlinePlus a609021

Licence data EMA: Link, US FDA: link

Pregnancy

category

US: C ( Risk not ruled out)

Legal status

℞ ( Prescription only)

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 52% ( active metabolite)

Protein binding 50% ( active metabolite)

Metabolism Hepatic ( CYP2D6- and 3A4- mediated)

Biological half- life 7–8 hours ( active metabolite)

Excretion Renal ( 70% ) and fecal ( 7% )

Identifiers

CAS Registry Number 286930- 03- 8

ATC code G04BD11

PubChem CID: 6918558

IUPHAR/ BPS 7473

DrugBank DB06702 Yes

ChemSpider 5293755 Yes

UNII 621G617227 Yes

KEGG D07226 Yes

ChEMBL CHEMBL1201764

Chemical data

Formula C26H37NO3

Molecular mass 411.278 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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