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Fenspiride Ip Bp Ep Usp Mnaufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Fenspiride CAS No:

Batch No: FEN/ 011114 A. R. No 14/ FP/ FEN/ 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 powders

2. Identification

Complies HPLC

1H- NMR

Reaction for chlorides

3. Solubility Complies Freely soluble in water , soluble in methanol

4. Loss on drying 0.2% NMT 1.0%

5. PH 5.0 4.5 to 6.5

6. Single unknown impurity 0.1% NMT 0.5%

7. Total impurities 0.6% NMT 2.0%

8. Sulphated ash 0.02% NMT 0.1%

9. Residual solvents Complies Ethanol NMT 0.3%

10. Heavy metals Complies NMT 20 PPM

11. Assay 99.4% 98% to 102%

. .

Fenspiride

Fenspiride. svg

Fenspiride ball- and- stick model. png

Systematic ( IUPAC) name

8- ( 2- phenylethyl) - 1- oxa- 3, 8- diazaspiro[ 4.5] decan- 2- one

Clinical data

Trade names Eurespal, Pneumorel

AHFS/ Drugs. com International Drug Names

Legal status

℞ ( Prescription only)

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 90% [ 1]

Biological half- life 14–16 hours

Excretion Urine ( 90% ) , feces ( ~10% )

Identifiers

CAS Registry Number 5053- 06- 5 Yes

ATC code R03BX01 R03DX03

PubChem CID: 68626

DrugBank DB08979

UNII S983QC7HKM

KEGG D07949 Yes

ChEMBL CHEMBL576127

Chemical data

Formula C15H20N2O2

Molecular mass 260.331 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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