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Rufinamide Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Rufinamide CAS No: 106308- 44- 5

Batch No: RUF/ 011114 A. R. No 14/ FP/ RUF/ 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 off white crystalline powder

2. Identification Complies IR absorption spectrum should be concordant with that of working standard

3. Solubility Complies Soluble freely in water & methanol

4. Water content 0.2%

NMT 0.5%

5. Related substances

1. Single Maximum Impurity

2. Total impurities

0.14%

0.35%

NMT 0.5%

NMT 1.0%

6. Melting point 233.0°C 232°C to 234°C

7. Residual Solvents :

a) Isopropanol

b) Ethyl acetate

c) Toluene

d) DMSO

Not detected

0.16%

NMT 0.3%

NMT 0.09%

8. Sulphated ash 0.12% NMT 0.1%

9. Heavy metals 10 PPM

NMT 10 PPM

10. Residue on ignition 0.03% NMT 0.1%

11. Assay by HPLC 99.50% NLT 99.0% w/ w to NMT 101.0% w/ w on dried basis

Rufinamide

Rufinamid. svg

Systematic ( IUPAC) name

1- ( 2, 6- Difluorobenzyl) - 1H- 1, 2, 3- triazole- 4- carboxamide

Clinical data

AHFS/ Drugs. com Consumer Drug Information

MedlinePlus a609001

Licence data EMA: Link, US FDA: link

Legal status

℞ ( Prescription only)

Routes of

administration Oral

Identifiers

CAS Registry Number 106308- 44- 5

ATC code N03AF03

PubChem CID: 129228

IUPHAR/ BPS 7470

ChemSpider 114471 Yes

UNII WFW942PR79 Yes

ChEMBL CHEMBL1201754

Chemical data

Formula C10H8F2N4O

Molecular mass 238.194


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 14, 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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