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Ticagrelor Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Ticagrelor CAS No: 274693- 27- 5

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

2. Identification Complies

Complies IR

HPLC

3. Loss on drying 0.24% NMT 0.5%

4. Melting point 151.6°C to 152.1°C 146°C to 153°C

5. Optical rotation - 53.5.0° Methanol C=1 - 40- - 60 0°

6. Residue on Ignition 0.1% NMT 0.5%

7. Heavy metal 20 PPM NMT 20 PPM

8. Related substance

Single impurity

Total impurities

0.08%

0.4

NMT 0.5%

NMT 1.0%

9. Residual Solvent 700 PPM

Not detected

19.8 PPM Methanol<3000 700ppm

Ethanol<5000 ND

Acetone<5000

N( CH3CH2) 3<300

10. Assay ( HPLC) 99.6% NLT 99.0%

Ticagrelor. svg

Ticagrelor ball- and- stick animation. gif

Systematic ( IUPAC) name

( 1S, 2S, 3R, 5S) - 3- [ 7- [ ( 1R, 2S) - 2- ( 3, 4- Difluorophenyl) cyclopropylamino] - 5- ( propylthio) - 3H- [ 1, 2, 3] triazolo[ 4, 5- d] pyrimidin- 3- yl] - 5- ( 2- hydroxyethoxy) cyclopentane- 1, 2- diol

Clinical data

Trade names Brilinta, Brilique, Possia

AHFS/ Drugs. com monograph

MedlinePlus a611050

Licence data EMA: Link, US FDA: link

Pregnancy

category

US: C ( Risk not ruled out)

Legal status

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 36%

Protein binding >99.7%

Metabolism Hepatic ( CYP3A4)

Biological half- life 7 hrs ( ticagrelor) , 8.5 hrs ( active metabolite AR- C124910XX)

Excretion Biliary

Identifiers

CAS Registry Number 274693- 27- 5 Yes

ATC code B01AC24

PubChem CID: 9871419

IUPHAR/ BPS 1765

ChemSpider 8047109

UNII GLH0314RVC Yes

KEGG D09017 Yes

ChEMBL CHEMBL398435

Synonyms AZD- 6140

Chemical data

Formula C23H28F2N6O4S

Molecular mass 522.567 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 14, 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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