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Artesunate Usp Ep Ip Bp Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Artesunate CAS No: 88495- 63- 0

Batch No: ART/ 011114 A. R. No 14/ FP/ ART/ 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 A white crystalline powder, odourless, almost tasteless.

2. IDENTIFICATION

( 1) Color reaction

( 2) Color reaction

Complies

Complies

The solution a red colour is produced

The solution a purple colour is produced

3. Solubility Complies Freely soluble in ethanol, in acetone and in chloroform; very slightly soluble in water.

4. Melting Point 134.8ºC to 135.6℃ 132ºC to 136℃

5. Specific Rotation 5.2° +4.5°~ +6.5°( c=25mg/ ml Dichloromethane)

6. ( 3) Liquid chromatogram Complies The retention time of the principal peak of the substance being examined in the chromatogram obtained in the Assay is identical with that of artesunate CRS in the chromatogram of the reference solution.

7. ( 4) IR identify with the reference spectrum Should be concordant with the reference spectrum

8. Acidity 4.5 3.5 to 5.0

9. Clarity and colour of

solution Complies Should comply with the specification

10. Chloride Complies Should comply with the specification

11. Related substances

Individual impurity

Total impurities

0.45% , no impurity detected between 0.5% ~1.0% .

0.45%

NMT 0.5% , and impurity detected between 0.5% to 1.0% should not more than one.

NMT 2.0%

12. Water 0.25% NMT 0.5%

13. Residue on ignition 0.03% NMT 0.1%

14. Heavy metals Complies NMT 0.002%

15. Assay 99.2% 98.0% to 102.0%

. .

Artesunate

Artesunate. svg

Clinical data

AHFS/ Drugs. com International Drug Names

Legal status

Not licensed in UK or US

Routes of

administration oral, IV, IM

Identifiers

CAS Registry Number 88495- 63- 0

80155- 81- 3 ( sodium salt)

ATC code P01BE03

PubChem CID: 5464098

ChemSpider 16735675 Yes

UNII 60W3249T9M Yes

ChEMBL CHEMBL258608

NIAID ChemDB 112081

Chemical data

Formula C19H28O8

Molecular mass 384.421 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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