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Darifenacin Hydrobromide Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Darifenacin hydrobromide CAS No: 133099- 07- 7

Batch No: DAR/ 011114 A. R. No 14/ FP/ DAR/ 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 almost white crystalline powder

2. Specific optical rotation +46.43° +44° to + 48°

3. Melting point 227.5℃ to 231.0℃ 227℃ to 232℃

4. Loss on drying 0.22% NMT 1.0%

5. Residue on ignition 0.05% NMT 0.1%

6. Heavy metals Complies NMT 20 PPM

7. Total impurities 0.36% NMT 0.5%

8. Single known impurity 0.11% NMT 0.3%

9. Single unknown impurity Complies NMT 0.2%

10. Residual solvents

Acetone

Methanol

Complies

Complies

NMT 5000 PPM

NMT 3000 PPM

11. Assay 100.8% NLT 98.5%

Darifenacin

Darifenacin. svg

Darifenacin- hydrobromide- from- xtal- 2009- CM- 3D- balls. png

Systematic ( IUPAC) name

( S) - 2- [ 1- [ 2- ( 2, 3- dihydrobenzofuran- 5- yl) ethyl] pyrrolidin- 3- yl] - 2, 2- diphenyl- acetamide

Clinical data

Trade names Enablex

AHFS/ Drugs. com monograph

MedlinePlus a605039

Pregnancy

category

AU: B3

US: C ( Risk not ruled out)

Legal status

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 15 to 19% ( dose- dependent)

Protein binding 98%

Metabolism Hepatic ( CYP2D6- and CYP3A4- mediated)

Biological half- life 13 to 19 hours

Excretion Renal ( 60% ) and biliary ( 40% )

Identifiers

CAS Registry Number 133099- 04- 4 Yes

ATC code G04BD10

PubChem CID: 444031

IUPHAR/ BPS 321

DrugBank DB00496 Yes

ChemSpider 392054 Yes

UNII APG9819VLM Yes

KEGG D01699

ChEBI CHEBI: 391960 Yes

ChEMBL CHEMBL1346 Yes

Chemical data

Formula C28H30N2O2

Molecular mass 426.55 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 7, 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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