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Clopidogrel Bisulphate Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name CLOPIDOGREL BISULPHATE CAS No:

Batch No: CLO/ 011114 A. R. No 14/ FP/ CLO/ 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 or off- white powder

2. Identification Complies

Complies

Complies IR : An IR spectrum of sample is

concordant with IR spectrum of

Clopidogrel Bisulphate Form- II

working standard.

HPLC : The retention time of the major peak in

the chromatogram of the Assay

preparation corresponds to that in the

chromatogram of the Clopidogrel

Bisulphate Form- II Standard

preparation as obtained in the assay.

By sulphates

3. Solubility Complies Freely soluble in methanol

4. Loss on drying 0.34% NMT 0.50%

5. Related Compounds by HPLC

Compound A

Compound B

Compound C

Other impurity

Total impurities

0.17%

0.21%

0.75%

0.06%

1.20%

NMT 0.20%

NMT 0.30%

NMT 1.00%

NMT 0.10%

NMT 1.50%

6. Residue on ignition 0.07% NMT 0.10%

7. Assay 99.70% 97.0% to 101.5%

.

Clopidogrel

Clopidogrel skeletal formula. svg

Clopidogrel ball- and- stick model. png

Systematic ( IUPAC) name

( +) - ( S) - methyl 2- ( 2- chlorophenyl) - 2- ( 6, 7- dihydrothieno[ 3, 2- c] pyridin- 5( 4H) - yl) acetate

Clinical data

Trade names Plavix

AHFS/ Drugs. com monograph

MedlinePlus a601040

Licence data US FDA: link

Pregnancy

category

AU: B1

US: B ( No risk in non- human studies)

Legal status

AU: Prescription Only ( S4)

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability >50%

Protein binding 94–98%

Metabolism Hepatic

Biological half- life 7–8 hours ( inactive metabolite)

Excretion 50% renal

46% biliary

Identifiers

CAS Registry Number 113665- 84- 2 Yes

ATC code B01AC04

PubChem CID: 60606

IUPHAR/ BPS 7150

DrugBank DB00758 Yes

ChemSpider 54632 Yes

UNII A74586SNO7 Yes

KEGG D07729 Yes

ChEBI CHEBI: 37941 Yes

ChEMBL CHEMBL1771 Yes

Chemical data

Formula C16H16ClNO2S

Molecular mass 321.82 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 6, 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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