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Danazol Usp Ip Ep Bp Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Danazol USP CAS No: 17230- 88- 5

Batch No: DAN/ 030313 A. R. No 13/ FP/ DAN/ 0303

Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

Batch Quantity 165 kg Date of Retest Jan- 2016

Sr. No Test Results Acceptance Criteria

1. Appearance

2. Solubility

3. Identification

Complies By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

4. Related Substances

Individual Impurity Total Impurity

0.23 %

0.38%

NMT 0.5 %

NMT 1.0 %

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +23º Between + 21° to + 27°

6. Loss on drying 1.1% NMT 2.0%

7. Assay 100.81% 97.0% –102.0%

.

Danazol

Danazol. svg

Systematic ( IUPAC) name

( 1S, 2R, 13R, 14S, 17R, 18S) - 17- ethynyl- 2, 18- dimethyl- 7- oxa- 6- azapentacyclo[ ] icosa- 4( 8) , 5, 9- trien- 17- ol

Clinical data

Trade names Azol, Bonzol, Cyclomen, Danol, Nazol

AHFS/ Drugs. com monograph

MedlinePlus a682599

Pregnancy

category

AU: D

US: X ( Contraindicated)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Metabolism Hepatic ( extensive to 2- hydroxymethyl ethisterone, ethisterone and 17- hydroxymethylethisterone) [ 1]

Biological half- life 3- 6 hours ( single dose) , 26 hours ( repeated dosing) [ 1]

Excretion Urine, faeces[ 1]

Identifiers

CAS Registry Number 17230- 88- 5 Yes

ATC code G03XA01

PubChem CID: 28417

IUPHAR/ BPS 6942

DrugBank DB01406 Yes

ChemSpider 26436 Yes

UNII N29QWW3BUO Yes

KEGG D00289 Yes

ChEBI CHEBI: 4315 Yes

ChEMBL CHEMBL1479 Yes

Synonyms 17β - hydroxy- 2, 4, 17α - pregnadien- 20- yno[ 2, 3- D] isoxazole

Chemical data

Formula C22H27NO2

Molecular mass 337.5 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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