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Dabigatran Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Dabigatran CAS No: 211914- 51- 1

Batch No: DAB/ 011114 A. R. No 14/ FP/ DAB/ 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 powder

2. Water 0.08% NMT 0.2%

3. Identification Complies

Complies IR

HPLC

4. Related substance

Single impurity

Total impurity

0.08%

0.12%

NMT 0.2%

NMT 2.0%

5. Assay 99.25% 98.5% to 101.0%

.

Dabigatran etexilate

Dabigatran etexilate structure. svg

Systematic ( IUPAC) name

Ethyl N- [ ( 2- { [ ( 4- { N‍   ' ​ - [ ( hexyloxy) carbonyl] carbamimidoyl} phenyl) amino] methyl} - 1- methyl- 1H- benzimidazol- 5- yl) carbonyl] - N- 2- pyridinyl- β - alaninate

Clinical data

Trade names Pradaxa, Pradax, Prazaxa

Licence data EMA: Link, US FDA: link

Pregnancy

category

US: C ( Risk not ruled out)

Legal status

CA: Schedule VI

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration oral

Pharmacokinetic data

Bioavailability 3–7% [ 1]

Protein binding 35% [ 1]

Biological half- life 12–17 hours[ 1]

Identifiers

CAS Registry Number 211915- 06- 9

ATC code B01AE07

PubChem CID: 6445226

DrugBank DB06695 Yes

ChemSpider 4948999 Yes

ChEMBL CHEMBL539697 Yes

Chemical data

Formula C34H41N7O5

Molecular mass 627.734 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 7, 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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