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Voriconazole Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Voriconazole CAS No: 137234- 62- 9

Batch No: VOR/ 011114 A. R. No 14/ FP/ VOR/ 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 IR

3. Solubility Complies Slightly soluble in water, freely soluble in acetone

and in methylene chloride

4. Appearance of solution Complies Clear and colorless

5. Enantiomeric purity Complies Impurity D: NMT0.20%

6. Impurity E 20 PPM NMT 0.10%

7. Heavy Metals Complies NMT 10 PPM

8. Assay 99.38% 97.50% to 102.0%

9. Related Substances

( By HPLC)

Impurity A

Impurity B

Impurity C

Other single impurity

Total impurities

Not detected

Complies

0.16%

NMT 0.15%

NMT 0.10%

NMT 0.50%

10. Water ( By K. F. ) 0.15% NMT 0.40%

11. Residue on ignition 0.05% NMT 0.10%

.

Voriconazole structure. svg

Voriconazole ball- and- stick model. png

Systematic ( IUPAC) name

( 2R, 3S) - 2- ( 2, 4- Difluorophenyl) - 3- ( 5- fluoropyrimidin- 4- yl) - 1- ( 1H- 1, 2, 4- triazol- 1- yl) butan- 2- ol

Clinical data

Trade names VFEND

AHFS/ Drugs. com monograph

MedlinePlus a605022

Licence data EMA: Link, US FDA: link

Pregnancy

category

D

Legal status

℞ ( Prescription only)

Routes of

administration IV, oral

Pharmacokinetic data

Bioavailability 96%

Protein binding 58%

Metabolism Hepatic cytochrome P450 enzymes CYP2C19, CYP2C9, CYP3A4

Biological half- life Dose- dependent

Identifiers

CAS Registry Number 137234- 62- 9 Yes

ATC code J02AC03

PubChem CID: 71616

DrugBank DB00582 Yes

ChemSpider 64684 Yes

UNII JFU09I87TR Yes

KEGG D00578 Yes

ChEBI CHEBI: 10023 Yes

ChEMBL CHEMBL638 Yes

Chemical data

Formula C16H14F3N5O

Molecular mass 349.311 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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