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Dronedarone Hydrochloride Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name DRONEDARONE HYDROCHLORIDE CAS No:

Batch No: DRO/ 011114 A. R. No 14/ FP/ DRO/ 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 crystalline powder; odorless

2. Solubility Complies Freely soluble in methanol, soluble in ethanol, practically

insoluble in water and 0.1mol/ L hydrochloric acid

3. Identification Complies

Complies

Complies HPLC: Retention time of major peak obtained with test solution

correspond to retention time of major peak obtained with

reference solution as obtained by assay

IR: The IR spectrum of the test sample correspond to those of

the reference standard

UV: The sample has maximum absorption at wavelength at

290nm and 248nm, has minimum absorption at wavelength at

263nm and 240nm

Chloride: The test sample indicates positive reaction with

chloride

4. Melting point 141.0℃ to 142.0℃ Between 139.0℃ and 144.0℃

5. Water 0.15% NMT 1.0%

6. Residue on igntion 0.02% NMT 0.1%

7. Heavy metals Complies NMT 20 PPM

8. Related substances

Impurity A

Individual impurity

Total impurities

0.09%

0.04%

0.13%

NMT 0.15%

NMT 0.1%

NMT 1.0%

Dronedarone

Dronedarone structure. svg

Systematic ( IUPAC) name

N- ( 2- Butyl- 3- ( p- ( 3- ( dibutylamino) propoxy) benzoyl) -

5- benzofuranyl) methanesulfonamide

Clinical data

Trade names Multaq

AHFS/ Drugs. com monograph

MedlinePlus a609034

Licence data US FDA: link

Pregnancy

category

US: X ( Contraindicated)

Legal status

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 15% ( with a high- fat meal) [ 1]

Protein binding >98%

Metabolism Extensive hepatic ( mainly by CYP3A)

Biological half- life 13–19 hours

Excretion Feces ( 84% ) , urine ( ~6% )

Identifiers

CAS Registry Number 141626- 36- 0

ATC code C01BD07

PubChem CID: 208898

IUPHAR/ BPS 7465

ChemSpider 180996 Yes

UNII JQZ1L091Y2 Yes

KEGG D02537 Yes

ChEBI CHEBI: 50659 Yes

ChEMBL CHEMBL184412 Yes

Chemical data

Formula C31H44N2O5S

Molecular mass 556.758 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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