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Idebenone Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Idebenone CAS No: 58186- 27- 9

Batch No: IDE/ 011114 A. R. No 14/ FP/ IDE/ 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 An orange yellow or yellow, crystalline powder.

2. Identification Complies Comply with the standard

Comply with the standard

IR

3. Solubility Complies Insoluble in water, very soluble in methanol, chloroform, freely soluble in anhydrous alcohol and ethyl acetate.

4. E

468 458 to 486

5. Melting point 53.9ºC to 54.3℃ 52ºC to 55ºC

6. Loss on drying 0.02% NMT 0.1%

7. Residue on ignition 0.03% NMT 0.1%

8. Heavy metals Complies NMT 10 PPM

9. Impurities 0.7% NMT 0.8%

10. Assay 99.2% NLT 98.5%

11. Residual solvents

Hexane

Methanol

Toulene

0.017%

ND

0.021%

NMT 0.029%

NMT 0.3%

NMT 0.089%

Idebenone

Idebenone. svg

Systematic ( IUPAC) name

2- ( 10- hydroxydecyl) - 5, 6- dimethoxy- 3- methyl-

cyclohexa- 2, 5- diene- 1, 4- dione

Clinical data

Trade names Catena, Raxone, Sovrima

AHFS/ Drugs. com International Drug Names

Legal status

Investigational

Pharmacokinetic data

Bioavailability <1% ( high first pass effect)

Protein binding >99%

Biological half- life 18 hours

Excretion Urine ( 80% ) and feces

Identifiers

CAS Registry Number 58186- 27- 9 Yes

ATC code N06BX13

PubChem CID: 3686

ChemSpider 3558 Yes

UNII HB6PN45W4J Yes

KEGG D01750 Yes

ChEMBL CHEMBL252556 Yes

Chemical data

Formula C19H30O5

Molecular mass 338.439 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 9, 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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