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Glibenclamide Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Glibenclamide CAS No:

Batch No: GLI/ 011114 A. R. No 14/ FP/ GLI/ 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 crystalline powder, odorless, tasteless

2. Identification Complies

Have maximum absorption at 274nm ~ 300nm wavelength, and have minimum absorption at 272nm~ 278nm wavelength.

IR spectrum of sample should be concordant with that of glibenclamide working standard.

TLC: The principal spot obtained with the test solution should be similar in position and size to the principal spot obtained in the chromatogram botained with the repernce solution.

3. Solubility Complies Practically insoluble in water, Sparingly soluble in methylene chloride, slightly soluble in alcohol and methanol

4. Melting point 172ºC 170ºC to 174ºC

5. Chloride 0.014% NMT 0.2%

6. Sulphate 0.04% NMT 0.1%

7. Related substances

0.09%

0.01%

0.03%

0.02%

0.12% Impurity A≤ 0.5%

Impurity B≤ 0.5%

Any other impurity≤ 0.2%

Unknown impurity- 1≤ 0.1%

Unknown impurity- 2≤ 0.1%

Total of other impurities≤ 0.5%

8. Loss on drying 0.3% NMT 0.5%

9. Residue on ignition 0.05% NMT 0.1%

10. Heavy metals 10 PPM NMT 10 PPM

11. Bacteria 10 cfu/ g NMT 1000 cfu/ g

12. Yeast & Mould 10 cfu/ g NMT 100 cfu/ g

13. E. coli

14. Assay 99.5% 99.0% to 101.0%

Glibenclamide

Glibenclamide structural formula V. 1. svg

Glibenclamide 3D. png

Systematic ( IUPAC) name

5- chloro- N- ( 4- [ N- ( cyclohexylcarbamoyl) sulfamoyl] phenethyl) - 2- methoxybenzamide

Clinical data

Trade names Diabeta, Glynase, Micronase Daonil, Semi- Daonil, Euglucon, Delmide, Glybovin Gilemal

AHFS/ Drugs. com International Drug Names

MedlinePlus a684058

Licence data US FDA: link

Pregnancy

category

AU: C

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

Legal status

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Protein binding Extensive

Metabolism Hepatic hydroxylation ( CYP2C9- mediated)

Biological half- life 10 hours

Excretion Renal and biliary

Identifiers

CAS Registry Number 10238- 21- 8 Yes

ATC code A10BB01

PubChem CID: 3488

IUPHAR/ BPS 2414

DrugBank DB01016 Yes

ChemSpider 3368 Yes

UNII SX6K58TVWC Yes

KEGG D00336 Yes

ChEBI CHEBI: 5441 Yes

ChEMBL CHEMBL472 Yes

Chemical data

Formula C23H28ClN3O5S

Molecular mass 494.004 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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