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Montelukast Sodium Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name MONTELUKAST SODIUM CAS No: 151767- 02- 1

Batch No: MON/ 011114 A. R. No 14/ FP/ MON/ 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 pale yellow

Powder.

2. Solubility Complies Freely soluble in

methanol. ethanol, water,

insoluble in acetonitrile.

3. Identification Complies Infra red spectrum is

concordant with that of

working standerd of

montelukast sodium.

4. Loss on drying 0.25% NMT 1.0%

5. Impurities

1.0 Dihydro Impurities.

2.0 Sulphoxide.

3.0 Styrene.

4.0 Methyl ketone

hydroxyl compound.

5.0 Cis isomer.

a. Other isomer.

b. Totol Impurities.

c. Major Unknown

Impurities.

0.08%

Nil.

0.21% .

Nil.

NMT: 1.0% .

NMT: 0.15% .

NMT: 0.1% .

6. Assay 99.1% 99% to 101%

Montelukast2DCSD. svg

Montelukast 3D ball- and- stick. png

Systematic ( IUPAC) name

( R, E) - 2- ( 1- ( ( 1- ( 3- ( 2- ( 7- chloroquinolin- 2- yl) vinyl) phenyl) - 3- ( 2- ( 2- hydroxypropan- 2- yl) phenyl) propylthio) methyl) cyclopropyl) acetic acid

Clinical data

Trade names Singulair

AHFS/ Drugs. com monograph

MedlinePlus a600014

Pregnancy

category

AU: B1

US: B ( No risk in non- human studies)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 63% to 73%

Protein binding 99%

Metabolism Hepatic ( CYP3A4 and CYP2C9- mediated)

Biological half- life 2.7- 5.5 hours

Excretion Biliary

Identifiers

CAS Registry Number 158966- 92- 8 Yes

ATC code R03DC03

PubChem CID: 5281040

IUPHAR/ BPS 3340

DrugBank DB00471 Yes

ChemSpider 4444507 Yes

UNII MHM278SD3E Yes

KEGG D08229 Yes

ChEBI CHEBI: 50730 Yes

ChEMBL CHEMBL787 Yes

Chemical data

Formula C35H36ClNO3S

Molecular mass 586.184 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 10, 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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