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Aprepitant Usp Ip Ep Bp Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Aprepitant CAS No: 170729- 80- 3

Batch No: APR/ 011114 A. R. No 14/ FP/ APR/ 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 Off- white to light yellow powder

2. Specific optical rotation 67.49° +68.0° ±3° ( c=1.0, in Methanol)

3. Identification

Complies IR, HPLC

4. Melting point 248°C to 250°C 248±5 °C

5. Water 0.29% NMT 0.5%

6. Heavy metals Complies NMT 10 PPM

7. Residue on ignition 0.07% NMT 0.1%

8. Enantiomer purity 0.07% NMT 0.15% S, R, S- enantiomer

9. Related substances

Desfluoro aprepitant

R, R, R- Diastereomer

Any other individual impurity

Total impurities

0.09%

0.08%

0.06%

0.29%

NMT 0.15%

NMT 0.10%

NMT 0.50%

10. Assay 99.9% 98.0% to 102.0%

11. Organic volatile impurities Complies Methanol NMT 2500 ppm; Xylene NMT

2170 ppm; Toluene NMT 890 ppm; DMSO

NMT 5000ppm

. .

Aprepitant

Structural formula of aprepitant

Ball- and- stick model of the aprepitant molecule

Systematic ( IUPAC) name

5- ( [ ( 2R, 3S) - 2- ( ( R) - 1- [ 3, 5- bis( trifluoromethyl) phenyl] ethoxy) - 3- ( 4- fluorophenyl) morpholino] methyl) - 1H- 1, 2, 4- triazol- 3( 2H) - one

Clinical data

Trade names Emend

AHFS/ Drugs. com monograph

MedlinePlus a604003

Pregnancy

category

AU: B1

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

Legal status

AU: Prescription Only ( S4)

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 60- 65%

Protein binding >95%

Metabolism Hepatic ( mostly CYP3A4- mediated; some contributions by CYP2C19 & CYP1A2)

Biological half- life 9- 13 hours

Excretion Urine ( 5% ) , faeces ( 86% )

Identifiers

CAS Registry Number 170729- 80- 3 Yes

ATC code A04AD12

PubChem CID: 6918365

IUPHAR/ BPS 3490

DrugBank DB00673 Yes

ChemSpider 5293568 Yes

UNII 1NF15YR6UY Yes

ChEBI CHEBI: 499361 Yes

ChEMBL CHEMBL1471 Yes

Chemical data

Formula C23H21F7N4O3

Molecular mass 534.427 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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