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Fingolimod Hydrochloride Usp Ip Bp Mnaufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Fingolimod Hydrochloride CAS No: 162359- 56- 0

Batch No: FIN/ 011114 A. R. No 14/ FP/ FIN/ 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 powder

2. Assay 99.4% NLT 99.0%

3. Melting point 108ºC 107ºC to 110ºC

4. Residue on ignition 0.22% NMT 0.3%

5. Heavy metals 5 PPM NMT 10 PPM

6. Related substances Complies NMT 0.1%

7. Total impurity 0.6% NMT 1.0%

. .

Fingolimod

Fingolimod2DACS. svg

Fingolimod3Dan. gif

Systematic ( IUPAC) name

2- amino- 2- [ 2- ( 4- octylphenyl) ethyl] propane- 1, 3- diol

Clinical data

Trade names Gilenya

AHFS/ Drugs. com monograph

Licence data EMA: Link, US FDA: link

Pregnancy

category

AU: D

US: C ( Risk not ruled out)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Identifiers

CAS Registry Number 162359- 55- 9

ATC code L04AA27

PubChem CID: 107970

IUPHAR/ BPS 2407

ChemSpider 97087 Yes

UNII 3QN8BYN5QF Yes

ChEBI CHEBI: 63115

ChEMBL CHEMBL314854 Yes

Chemical data

Formula C19H33NO2

Molecular mass 307.471 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 8, 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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