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Darunavir Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Darunavir CAS No: 206361- 99- 1

Batch No: DAR/ 011114 A. R. No 14/ FP/ DAR/ 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 Light yellow to white solid

2. Identification Complies reference spectra

3. Assay 99.52% NLT 98.0%

4. Water 0.20% NMT 0.5%

5. Single impurity 0.16% NMT 0.5%

Darunavir

Darunavir structure. svg

Darunavir ball- and- stick animation. gif

Systematic ( IUPAC) name

[ ( 1R, 5S, 6R) - 2, 8- dioxabicyclo[ 3.3.0] oct- 6- yl] N- [ ( 2S, 3R) - 4- [ ( 4- aminophenyl) sulfonyl- ( 2- methylpropyl) amino] - 3- hydroxy- 1- phenyl- butan- 2- yl] carbamate

Clinical data

Trade names Prezista

AHFS/ Drugs. com monograph

MedlinePlus a607042

Pregnancy

category

AU: B2

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 37% ( without ritonavir) , 82% ( with ritonavir)

Protein binding 95%

Metabolism hepatic ( CYP3A4)

Biological half- life 15 hours

Excretion Faeces ( 80% ) , urine ( 14% )

Identifiers

CAS Registry Number 206361- 99- 1 Yes

ATC code J05AE10

PubChem CID: 213039

DrugBank DB01264 Yes

ChemSpider 184733 Yes

UNII YO603Y8113 Yes

KEGG D03656 Yes

ChEBI CHEBI: 367163 Yes

ChEMBL CHEMBL1323

NIAID ChemDB 073035

Chemical data

Formula C27H37N3O7S

Molecular mass 547.665 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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