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Fenofibrate Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Fenofibrate 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 powder

2. Solubility Complies Practically insoluble in water very soluble in methylene chloride slightly soluble in ethanol 96%

3. Identification 81ºC

Complies A) Melting point 79ºC to 82ºC

B) Infrared absorption spectrophotometery

4. Appearance of solution Complies The solution is clear and not more intensely coloured than reference solution

5. Acidity Complies NMT 0.2 ml of 0.1 M sodium hydroxide is required to change the colour of the indicator to pink

6. Related substances by HPLC

Impurity A

Impurity B

Impurity G

Unspecified impurities

Total impurities

NMT 0.1%

NMT 0.2%

NMT 0.10%

NMT 0.5%

0.012%

Not detected

0.067%

0.236%

7. Halides expressed as chlorides 100 PPM NMT 100 PPM

8. Sulphates 100 PPM NMT 100 PPM

9. Heavy metals 20 PPM NMT 20 PPM

10. Loss on drying 0.14% NMT 0.5%

11. Sulphated ash 0.06% NMT 0.1%

12. Assay by HPLC 99.764% 98.0% to 102.0%

. .

Fenofibrate

Fenofibrate structure. svg

Systematic ( IUPAC) name

propan- 2- yl 2- { 4- [ ( 4- chlorophenyl) carbonyl] phenoxy} - 2- methylpropanoate

Clinical data

Trade names Fenoglide, Lipofen

AHFS/ Drugs. com monograph

MedlinePlus a601052

Pregnancy

category

US: C ( Risk not ruled out)

Legal status

Legend

Routes of

administration Oral

Pharmacokinetic data

Protein binding 99%

Metabolism glucuronidation

Biological half- life 20 hours

Excretion urine ( 60% ) , feces ( 25% )

Identifiers

CAS Registry Number 49562- 28- 9 Yes

ATC code C10AB05

PubChem CID: 3339

IUPHAR/ BPS 7186

DrugBank DB01039 Yes

ChemSpider 3222 Yes

UNII U202363UOS Yes

KEGG D00565 Yes

ChEBI CHEBI: 5001 Yes

ChEMBL CHEMBL672 Yes

Chemical data

Formula C20H21ClO4

Molecular mass 360.831 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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