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Dihydroartemisinin Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Dihydroartemisinin CAS No:

Batch No: DIH/ 011114 A. R. No 14/ FP/ DIH/ 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 needle crystal, odorless, bitter taste

2. Identification

( 1) Color reaction of

potassium iodide R.

( 2) Color reaction of

vanillin/ sulfuric acid

TS1.

( 3) Specific optical

Rotation.

( 4) IR

Complies

Complies

1. A bluish purple colour is produced

2. A red colour is produced which

changes gradually to

brown on standing

3. dextrorotatory

4. The infrared absorption spectrum is

concordant with

the reference spectrum of artemether

3. Solubility Complies Freely soluble in chloroform, soluble

in acetone,

sparingly soluble in methanol and

ethanol, practically

insoluble in water.

4. Melting point 145ºC to 147℃ 145ºC to 150℃

5. Related substances Complies Impurity spot not more than one, and

the

color of Impurity spot is not more

intense than the

principal spot reference solution

( 2.0% )

6. Loss on drying 0.02% NMT 0.5%

7. Sulphated ash 0.09% NMT 0.1%

8. Residual solvents Complies Methanol NMT 0.3%

9. Heavy metals Complies NMT 0.001%

10. Plate count Complies NMT 100 cfu/ g

11. Yeast & Mould Complies NMT 100 cfu/ g

12. E. coli Complies Negative

13. Assay 100.2% 98.0% to 102.0%

. .

Dihydroartemisinin

Artenimol. png

Systematic ( IUPAC) name

( 3R, 5aS, 6R, 8aS, 9R, 12S, 12aR) - decahydro- 3, 6, 9- trimethyl- 3, 12- epoxy- 12H- pyrano[ 4, 3- j] - 1, 2- benzodioxepin- 10- ol

Clinical data

AHFS/ Drugs. com International Drug Names

Legal status

℞ ( Prescription only)

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 12%

Metabolism Liver

Biological half- life About 4- 11 hours

Excretion Mainly Bile

Identifiers

CAS Registry Number 71939- 50- 9 Yes

ATC code P01BE05

PubChem CID: 107770

ChemSpider 2272104 Yes

UNII 6A9O50735X Yes

ChEMBL CHEMBL25164

Chemical data

Formula C15H24O5

Molecular mass 284.35 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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