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Finasteride Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Finasteride USP CAS No: 98319- 26- 7

Batch No: FIN/ 030313 A. R. No 13/ FP/ FIN/ 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) By HPLC: 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

0.24 %

0.39%

NMT 0.5%

NMT 1.0%

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) - 57º Between - 56.0° to - 60.0°,

6. Heavy Metals Complies 10ppm

7. Water Content by KF 0.09% NMT 0.3%

8. Residue On Ignition 0.043% NMT 0.1%

9. Assay HPLC 99.24% 98.5% –101.0%

.

Finasteride

Finasteride. svg

Finasteride- 3D- balls. png

Systematic ( IUPAC) name

N- ( 1, 1- dimethylethyl) - 3- oxo-

( 5α , 17β ) - 4- azaandrost- 1- ene- 17- carboxamide

Clinical data

Trade names Propecia, Proscar

AHFS/ Drugs. com monograph

MedlinePlus a698016

Pregnancy

category

X ( will cause birth defects in a fetus)

Legal status

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 63%

Metabolism Hepatic

Biological half- life Elderly: 8 hours

Adults: 6 hours

Excretion Feces ( 57% ) and urine ( 39% ) as metabolites

Identifiers

CAS Registry Number 98319- 26- 7 Yes

ATC code G04CB01 D11AX10

PubChem CID: 57363

IUPHAR/ BPS 6818

DrugBank DB01216 Yes

ChemSpider 51714 Yes

UNII 57GNO57U7G Yes

KEGG D00321 Yes

ChEBI CHEBI: 5062 Yes

ChEMBL CHEMBL710 Yes

Chemical data

Formula C23H36N2O2

Molecular mass 372.549 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 8, 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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