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Dexmedetomidine Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Dexmedetomidine CAS No:

Batch No: DEX/ 011114 A. R. No 14/ FP/ DEX/ 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 or off- white crystalline powder

2. Melting point 148ºC to 152ºC 145ºC to 152ºC

3. Specific rotation +73.9º +72º to +76º

4. Related substance 0.16% NMT 1.0%

5. Levomedetomidine

Hydrochloride 0.06% NMT 1.0%

6. Loss on drying 0.23% NMT 1.0%

7. Residue on ignition 0.03% NMT 0.1%

8. Heavy metals Complies NMT 10 PPM

9. Assay 99.80% NLT 99.0%

Dexmedetomidine

Dexmedetomidine skeletal. svg

Systematic ( IUPAC) name

( S) - 4- [ 1- ( 2, 3- Dimethylphenyl) ethyl] - 3H- imidazole

Clinical data

Trade names Precedex, Dexdor

AHFS/ Drugs. com monograph

Pregnancy

category

US: C ( Risk not ruled out)

Legal status

US: ℞ - only

Routes of

administration Intravenous infusion only

Pharmacokinetic data

Protein binding 94%

Metabolism Near complete hepatic metabolism to inactive metabolites

Biological half- life 2 hours

Excretion Urinary

Identifiers

CAS Registry Number 113775- 47- 6 Yes

ATC code N05CM18

PubChem CID: 68602

IUPHAR/ BPS 521

DrugBank DB00633 Yes

ChemSpider 4470605 Yes

UNII 67VB76HONO Yes

KEGG D00514 Yes

ChEBI CHEBI: 4466 Yes

ChEMBL CHEMBL778 Yes

Chemical data

Formula C13H16N2

Molecular mass 200.28 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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