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Itraconazole Ep Ip Bp Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name ITRACONAZOLE EP CAS No: 84625- 61- 6

Batch No: ITR/ 011114 A. R. No 14/ FP/ ITR/ 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. Solubility Complies Practically insoluble in water, freely soluble in

methylene chloride, sparingly soluble in

tetrahydrofuran, very slightly soluble in

alcohol.

3. Identification 168.2°C to 169.3ºC

Complies

Complies A] Melting Point: 166ºC to 170ºC

B] By I. R.

C] By T. L. C

D] By reaction ( a) of Chloride.

4. Solution S Complies Dissolve 2gm in methylene chloride and

dilute to 20ml of the same solvent.

5. Appearance of solution Complies Solution S is clear and not more intensely

colored than reference solution BY6.

6. Optical rotation - 0.008º - 0.10º to +0.10º determined on solution S.

7. Related substances

[ By H. P. L. C. ]

Single impurity

Total impurity

0.18%

0.31%

NMT 0.50%

NMT 1.25%

8. Loss On Drying 0.25% NMT 0.5%

9. Sulphated Ash 0.07% NMT 0.1%

10. Assay [ By Titration] 99.63% 98.5% to 101.5% [ on dried basis]

Itraconazole

Itraconazole2DACS. svg

Systematic ( IUPAC) name

( 2R, 4S) - rel- 1- ( Butan- 2- yl) - 4- { 4- [ 4- ( 4- { [ ( 2R, 4S) - 2- ( 2, 4- dichlorophenyl) - 2- ( 1H- 1, 2, 4- triazol- 1- ylmethyl) - 1, 3- dioxolan- 4- yl] methoxy} phenyl) piperazin- 1- yl] phenyl} - 4, 5- dihydro- 1H- 1, 2, 4- triazol- 5- one

Clinical data

Trade names Sporanox

AHFS/ Drugs. com monograph

MedlinePlus a692049

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 and i. v. , Oral only ( UK and US)

Pharmacokinetic data

Bioavailability 55% , maximal if taken with full meal

Protein binding 99.8%

Metabolism hepatic ( CYP3A4)

Biological half- life 21 hours

Excretion Urine, faeces

Identifiers

CAS Registry Number 84625- 61- 6 Yes

ATC code J02AC02

PubChem CID: 55283

DrugBank DB01167 Yes

ChemSpider 49927 Yes

UNII 304NUG5GF4 Yes

KEGG D00350 Yes

ChEBI CHEBI: 6076 Yes

ChEMBL CHEMBL22587 Yes

Chemical data

Formula C35H38Cl2N8O4

Molecular mass 705.64


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 9, 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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