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Letrozole Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Letrozole USP CAS No: 112809- 51- 5

Batch No: LET/ 030313 A. R. No 13/ FP/ LET/ 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

0.03%

0.18%

NMT 0.1%

NMT 0.3%

5. Heavy Metals Complies 10ppm

6. Water Content by KF 4.7% NMT 0.3%

7. Residue On Ignition 0.065% NMT 0.1%

8. Assay HPLC 99.54% 98.0% –102.0%

Letrozole

Letrozole2DACS. svg

Letrozol3D. png

Systematic ( IUPAC) name

4, 4' - ( ( 1H- 1, 2, 4- triazol- 1- yl) methylene) dibenzonitrile

Clinical data

Trade names Femara

AHFS/ Drugs. com monograph

MedlinePlus a698004

Licence data US FDA: link

Pregnancy

category

US: D ( Evidence of risk)

Legal status

CA: Schedule VII

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 99.9%

Protein binding 60% , mainly to albumin

Metabolism pharmacologically- inactive carbinol metabolite ( 4, 4΄ - methanol- bisbenzonitrile) [ 1]

Biological half- life 2 days[ 1]

Excretion Kidneys[ 1]

Identifiers

CAS Registry Number 112809- 51- 5 Yes

ATC code L02BG04

PubChem CID: 3902

IUPHAR/ BPS 5209

DrugBank DB01006 Yes

ChemSpider 3765 Yes

UNII 7LKK855W8I Yes

KEGG D00964 Yes

ChEBI CHEBI: 6413 Yes

ChEMBL CHEMBL1444 Yes

Chemical data

Formula C17H11N5

Molecular mass 285.303 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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