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Dexamethasone Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Dexamethasone USP CAS No: 50- 02- 2

Batch No: DEX/ 030313 A. R. No 13/ FP/ DEX/ 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

0.32 %

1.32%

NMT 1.0%

NMT 2.0%

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +74º Between + 72° to +80°

6. Loss on drying 0.12% NMT 0.5%

7. Residue On Ignition 0.09% NMT 0.2%

8. Assay HPLC 98.43% 97.0% –102.0%

. .

Dexamethasone

Skeletal formula of dexamethasone

Ball- and- stick model of the dexamethasone molecule

Systematic ( IUPAC) name

( 8S, 9R, 10S, 11S, 13S, 14S, 16R, 17R) - 9- Fluoro- 11, 17- dihydroxy- 17- ( 2- hydroxyacetyl) - 10, 13, 16- trimethyl- - dodecahydro- 3H- cyclopenta[ a] phenanthren- 3- one

Clinical data

AHFS/ Drugs. com monograph

MedlinePlus a682792

Pregnancy

category

AU: A

US: C ( Risk not ruled out)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral, IV, IM, SC and IO

Pharmacokinetic data

Bioavailability 80- 90%

Protein binding 77%

Metabolism hepatic

Biological half- life 190 minutes

Excretion Urine ( 65% )

Identifiers

CAS Registry Number 50- 02- 2 Yes

ATC code A01AC02 C05AA09, D07AB19, D10AA03, H02AB02, R01AD03, S01BA01, S02BA06, S03BA01

PubChem CID: 5743

IUPHAR/ BPS 2768

DrugBank DB01234

ChemSpider 5541 Yes

UNII 7S5I7G3JQL Yes

KEGG D00292 Yes

ChEBI CHEBI: 41879 Yes

ChEMBL CHEMBL384467 Yes

Chemical data

Formula C22H29FO5

Molecular mass 392.461 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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