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Bicalutamide Usp Ip Ep Bp Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Bicalutamide CAS No:

Batch No: BIC/ 011114 A. R. No 14/ FP/ BIC/ 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 off- white crystalline powder

2. Solubility Complies Freely soluble in tetrahydrofuran and in acetone; soluble in acetonitrile; sparingly soluble in methanol slightly soluble in alcohol soluble

3. Identification Complies

Complies IR

HPLC

4. Water content 0.05% NMT 0.2%

5. Residue on ignition 0.08% NMT 0.1%

6. Heavy metals Complies NMT 0.001%

7. Related substance

Des- fluoro analog

2- Fluoro isomer

Des hydroxy analog

Individual unspecified impurity

Total unspecified impurities

Total impurities

0.04%

Not detected

0.03%

0.07%

0.19%

0.29%

0.2% Max

0.1% Max

0.3% Max

0.5% Max

8. Assay 99.8% 98.0% to 102.0%

9. Related substances

Dichloromethane

Ethanol

Complies

Complies

600ppm Max

5000ppm Max

. .

Bicalutamide

Bicalutamide. svg

Bicalutamide ball- and- stick. png

Systematic ( IUPAC) name

N- [ 4- cyano- 3- ( trifluoromethyl) phenyl] - 3- [ ( 4- fluorophenyl) sulfonyl] - 2- hydroxy- 2- methylpropanamide

Clinical data

Trade names Casodex

AHFS/ Drugs. com monograph

MedlinePlus a697047

Pregnancy

category

US: X ( Contraindicated)

Legal status

℞ ( Prescription only)

Routes of

administration Oral

Pharmacokinetic data

Bioavailability Well- absorbed

Protein binding 96%

Metabolism Hepatic ( CYP3A4)

Biological half- life 6 days

Identifiers

CAS Registry Number 90357- 06- 5 Yes

ATC code L02BB03

PubChem CID: 2375

IUPHAR/ BPS 2863

DrugBank DB01128 Yes

ChemSpider 2284 Yes

UNII A0Z3NAU9DP Yes

KEGG D00961

ChEMBL CHEMBL63560

Synonyms ICI- 176334[ 1]

PDB ligand ID 198 ( PDBe, RCSB PDB)

Chemical data

Formula C18H14F4N2O4S

Molecular mass 430.373 g/ mol


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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