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Ivabradine Hcl Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Ivabradine HCL CAS No: 148849- 67- 6

Batch No: IVA/ 011114 A. R. No 14/ FP/ IVA/ 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 HPLC

3. Residue on ignition 0.08% NMT 0.2%

4. Loss on drying 0.37% NMT 1.0%

5. Water 0.53% NMT 2.0%

6. Heavy metals Complies NMT 20 PPM

7. Specific rotation +7.4º +6.5º to +8.5º

8. Related substances

Single impurity

Total impurities

Isomer

0.07%

0.21%

Unetected

NMT 0.5%

NMT 1.0%

NMT 0.1%

9. Assay 100.2% NLT 98.0%

.

Ivabradine

Ivabradine Structural Formulae V. 1. svg

Ivabradine ball- and- stick. png

Systematic ( IUPAC) name

3- [ 3- ( { [ ( 7S) - 3, 4- dimethoxybicyclo[ 4.2.0] octa- 1, 3, 5- trien- 7- yl] methyl} ( methyl) amino) propyl] - 7, 8- dimethoxy- 2, 3, 4, 5- tetrahydro- 1H- 3- benzazepin- 2- one

Clinical data

AHFS/ Drugs. com International Drug Names

Licence data EMA: Link

Pregnancy

category

AU: D

Legal status

UK: Prescription- only ( POM)

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 40%

Protein binding 70%

Metabolism Hepatic ( first- pass) >50% , CYP3A4- mediated

Biological half- life 2 hours

Excretion Renal and fecal

Identifiers

CAS Registry Number 155974- 00- 8

ATC code C01EB17

PubChem CID: 132999

IUPHAR/ BPS 2357

ChemSpider 117373 Yes

UNII 3H48L0LPZQ Yes

KEGG D07165 Yes

ChEBI CHEBI: 85966 Yes

ChEMBL CHEMBL471737 Yes

Chemical data

Formula C27H36N2O5

Molecular mass 468.585 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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