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Ezetimibe Usp Ip Bp Ep Manufacturer - India

price: contact company for price

Ezetimibe

Ezetimibe. svg

Systematic ( IUPAC) name

( 3R, 4S) - 1- ( 4- fluorophenyl) - 3- [ ( 3S) - 3- ( 4- fluorophenyl) - 3- hydroxypropyl] - 4- ( 4- hydroxyphenyl) azetidin- 2- one

Clinical data

Trade names Zetia

AHFS/ Drugs. com monograph

MedlinePlus a603015

Pregnancy

category

AU: C

US: C ( Risk not ruled out)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

CERTIFICATE OF ANALYSIS

Product Name Ezetimibe CAS No: 163222- 33- 1

Batch No: EZE/ 011114 A. R. No 14/ FP/ EZE/ 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 Freely soluble in methanol, ethanol and acetone.

3. Identification

IR

HPLC

Complies

Complies

IR spectrum of the sample in KBr dispersion should concordant with Ezetimibe working standard

The retention time of the main peak in the chromatogram of the test preparation should match to that in the chromatogram of the standard preparation

4. specific optical rotation [ a] 22 D ( c=3, InMethanol) - 28.86° - 25.0° to - 34.0°

5. Related substance

A) EZB- 1 Impurity

B) Desfluro Impurity

C) Any Other Impurity

D) Total Impurities

Not detected

0.19%

0.01%

0.24%

NMT 0.30%

NMT 0.50%

NMT 1.0%

6. Loss on drying 0.13%

NMT 0.5%

7. Heavy metals Complies NMT 20 PPM

8. Sulphates 100 PPM NMT 100 PPM

9. Heavy metals 20 PPM NMT 20 PPM

10. Residue on ignition 0.02% NMT 0.2%

11. Residual solvent

Methanol

Glacial acetic acid

N- hexane

Toluene

Ethyl acetate

Isopropanol

Dichloromethane

0.08%

Not detected

NMT 0.3%

NMT 0.5%

NMT 0.029%

NMT 0.089%

NMT 0.06%

12. Assay 99.52% 98.0% to 102.0%

.

Pharmacokinetic data

Bioavailability 35–65%

Protein binding >90%

Metabolism Intestinal wall, hepatic

Biological half- life 19–30 hours

Excretion Renal 11% , faecal 78%

Identifiers

CAS Registry Number 163222- 33- 1 Yes

ATC code C10AX09

PubChem CID: 150311

IUPHAR/ BPS 6816

DrugBank DB00973 Yes

ChemSpider 132493 Yes

UNII EOR26LQQ24 Yes

KEGG D01966 Yes

ChEBI CHEBI: 49040 Yes

ChEMBL CHEMBL1138 Yes

Chemical data

Formula C24H21F2NO3

Molecular mass 409.4 g· mol− 1


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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