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Modafinil Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Modafinil CAS No: 68693- 11- 8

Batch No: MOD/ 011114 A. R. No 14/ FP/ MOD/ 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 almost white crystal powder

2. Solubility Complies Very slightly soluble or practically insoluble in water springly soluble in methanol slightly soluble in ethanol

3. Melting point 164ºC to 165ºC 163ºC to 165ºC

4. Identification Complies IR

5. Related substances

Impurity A

Impurity B

Unspecified impurities

Total impurity

0.05%

0.03%

0.02%

0.1%

NMT 0.2%

NMT 0.5%

NMT 0.1%

NMT 1.0%

6. Loss on drying 0.18% NMT 0.5%

7. Sulphated ash 0.05% NMT 0.1%

8. Heavy metals Complies NMT 10 PPM

9. Assay 99.6% 98% to 102%

.

Modafinil2DACS. svg

Armodafinil ball- and- stick xtal 2013. png

Systematic ( IUPAC) name

2- benzhydrylsulfinylethanamide

Clinical data

Trade names Alertec, Modavigil, Modiodal, Provigil, Modalert

AHFS/ Drugs. com monograph

MedlinePlus a602016

Licence data US FDA: link

Pregnancy

category

AU: B3

US: C ( Risk not ruled out)

Legal status

AU: Prescription Only ( S4)

CA: Schedule F

UK: Prescription- only ( POM)

US: Schedule IV

Dependence

liability low

Addiction

Routes of

administration Oral

Pharmacokinetic data

Bioavailability Not determined due to the aqueous insolubility

Protein binding 62%

Metabolism Hepatic ( primarily via amide hydrolysis; [ 1] CYP1A2, CYP3A4, and CYP2B6) [ 2]

Biological half- life 15 hours ( R- enantiomer) ,

4 hours ( S- enantiomer) [ 3]

Excretion Urine ( 80% )

Identifiers

CAS Registry Number 68693- 11- 8 Yes

ATC code N06BA07

PubChem CID: 4236

IUPHAR/ BPS 7555

DrugBank DB00745 Yes

ChemSpider 4088 Yes

UNII R3UK8X3U3D Yes

KEGG D01832 Yes

ChEBI CHEBI: 31859

ChEMBL CHEMBL1373 Yes

Chemical data

Formula C15H15NO2S

Molecular mass 273.35 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 10, 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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