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Entecavir Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Entecavir CAS No: 142217- 69- 4

Batch No: ENT/ 011114 A. R. No 14/ FP/ ENT/ 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 almost white powder crystalline

powder

2. Identification Complies The IR absorption spectrum of the sample

must be concordant with entecavir

3. Specific rotation +26.2℃ +24℃ to +28℃

4. Loss on drying 6.2% 5.5% to 6.5%

5. Residue on ignition 0.05% NMT 0.1%

6. Related substances

Single impurity

Total impurities

0.07%

0.17%

NMT 0.5%

NMT 1.0%

7. Assay 99.3% NLT 99.0%

.

Entecavir

Entecavir structure. svg

Systematic ( IUPAC) name

2- Amino- 9- [ ( 1S, 3R, 4S) - 4- hydroxy- 3- ( hydroxymethyl) - 2- methylidenecyclopentyl] - 6, 9- dihydro- 3H- purin- 6- one

Clinical data

Trade names Baraclude

AHFS/ Drugs. com monograph

MedlinePlus a605028

Licence data EMA: Link, US FDA: link

Pregnancy

category

AU: B3

US: C ( Risk not ruled out)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability n/ a ( ≥ 70) [ 1]

Protein binding 13% ( in vitro)

Metabolism negligible/ nil

Biological half- life 128–149 hours

Excretion Renal 62–73%

Identifiers

CAS Registry Number 142217- 69- 4 Yes

ATC code J05AF10

PubChem CID: 153941

DrugBank DB00442 Yes

ChemSpider 135679

UNII NNU2O4609D Yes

KEGG D04008 Yes

ChEBI CHEBI: 59902 Yes

ChEMBL CHEMBL713

Chemical data

Formula C12H15N5O3

Molecular mass 277.279 g/ mol

SMILES[ show]

InChI[ show]

Physical data

Melting point 220 °C ( 428 °F) value applies to entecavir monohydrate and is a minimum value[ 2]


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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