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Atracurium Besylate Usp Ep Ip Bp Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Atracurium besylate CAS No:

64228- 81- 5

Batch No: ATR/ 011114 A. R. No 14/ FP/ ATR/ 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 yellowish- white powder

2. Solubility Complies Soluble in water, very soluble in acetonitrile, in ethanol ( 96 per cent) and in methylene chloride.

3. Identification Complies

Complies ( 1) IR

( 2) HPLC: the 3 principal isomeric peaks in the chromatogram obtained with test solution ( a) are similar in retention time to those in the chromatogram obtained with reference solution ( a) .

4. Appearance of solution Complies Solution S is clear and not more intensely coloured than reference solution Y7.

5. Impurity J Undetected NMT 10 PPM

6. Water 0.9% NMT 0.1%

7. Related substances

Impurity E

Impurity A

Impurity D

Impurity C

Impurity F

Impurity G

Impurity H I K

Any other impurity

Total impurities

0.09%

0.01%

0.11%

0.35%

0.02%

0.06%

0.07%

0.73%

NMT 1.5%

NMT 1.0%

NMT 0.1%

NMT 3.5%

8. Isomer composition

Atracurium cis- cis isomer

Atracurium cis- trans isomer

Atracurium trans- trans isomer

58.2%

36.2%

5.7%

55.0% to 60.0%

34.5% to 38.5%

5.0% to 6.5%

9. Sulphated ash 0.09% NMT 0.1%

10. Assay 100.2% 96.0% to 102.0%

11. Residual solvents

Dichloromethane

Acetonitrile

Ethyl ether

Toulene

Not detected

815 PPM

62 PPM

NMT 600 PPM

NMT 410 PPM

NMT 5000 PPM

NMT 890 PPM

.

Atracurium besilate

Atracurium. svg

Systematic ( IUPAC) name

2, 2' - { 1, 5- Pentanediylbis[ oxy( 3- oxo- 3, 1- propanediyl) ] } bis[ 1- ( 3, 4- dimethoxybenzyl) - 6, 7- dimethoxy- 2- methyl- 1, 2, 3, 4- tetrahydroisoquinolinium] dibenzenesulphonate

Clinical data

AHFS/ Drugs. com International Drug Names

Legal status

Worldwide: Prescription only medicine

Routes of

administration IV

Pharmacokinetic data

Bioavailability 100% ( IV)

Protein binding 82%

Metabolism Hofmann elimination ( retro- Michael addition) and ester hydrolysis by nonspecific esterases

Biological half- life 17–21 minutes

Identifiers

CAS Registry Number 64228- 79- 1

ATC code M03AC04

PubChem CID: 47319

DrugBank DB00732 Yes

ChemSpider 43067 Yes

UNII 40AX66P76P

ChEBI CHEBI: 2914 Yes

ChEMBL CHEMBL1360 Yes

Chemical data

Formula C53H72N2O122+

Molecular mass 929.145 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 5, 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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