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Bisoprolol Fumarate Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Bisoprolol Fumarate USP CAS No: 104344- 23- 2

Batch No: BIS/ 030313 A. R. No 13/ FP/ BIS/ 0303

Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

Batch Quantity 165 kg Date of Retest Jan- 2016

Sr. No Test Results Acceptance Criteria

1. Appearance

2. Solubility

3. Identification

Complies a) By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

Complies b) Liquid Chromatography: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.

4. Related Substances

Individual Impurity Total Impurity

0.27 %

0.31%

NMT 0.5 %

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +1.1º Between –2° to +2°

7. Water Content by KF 0.13% NMT 0.5%

8. Content Of Fumaric Acid 15.1% 14.8- 15.4%

10. Heavy Metals Complies NMT 20 ppm

11. Residue On Ignition 0.04% NMT 0.1%

12. Assay HPLC 98.58% 97.5 to 102.0%

. .

Bisoprolol

Bisoprolol. svg

Systematic ( IUPAC) name

( RS) - 1- { 4- [ ( 2- isopropoxyethoxy) methyl] phenoxy} -

3- ( isopropylamino) propan- 2- ol

Clinical data

Trade names Concor

AHFS/ Drugs. com monograph

MedlinePlus a693024

Licence data US FDA: link

Pregnancy

category

AU: C

US: C ( Risk not ruled out)

Legal status

℞ ( Prescription only)

Routes of

administration oral

Pharmacokinetic data

Bioavailability >90%

Protein binding 30% [ 1]

Metabolism 50% Hepatic, CYP2D6, CYP3A4[ 2]

Biological half- life 10–12 hours[ 3]

Identifiers

CAS Registry Number 66722- 44- 9 Yes

ATC code C07AB07

PubChem CID: 2405

IUPHAR/ BPS 7129

DrugBank DB00612 Yes

ChemSpider 2312 Yes

UNII Y41JS2NL6U Yes

KEGG D02342 Yes

ChEBI CHEBI: 3127 Yes

ChEMBL CHEMBL645 Yes

Chemical data

Formula C18H31NO4

Molecular mass 325.443 g/ mo


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 5, 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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