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Glimepiride Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Glimepiride CAS No: 93479- 97- 1

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 to off white powder

2. Identification Complies IR

3. Residue on ignition 0.06% NMT 0.2%

4. Heavy metals Complies NMT 10 PPM

5. Water 0.20% NMT 0.5%

6. Related substances

Impurity A

Impurity B

Impurity C

Impurity D

Single impurity

Total impurities

0.03%

0.05%

ND

0.12%

NMT 0.8%

NMT 0.4%

NMT 0.1%

NMT 0.2%

NMT 0.5%

7. Assay 99.58% 98% to 102%

Glimepiride

Glimepiride. svg

Systematic ( IUPAC) name

3- ethyl- 4- methyl- N- ( 4- [ N- ( ( 1r, 4r) - 4- methylcyclohexylcarbamoyl) sulfamoyl] phenethyl) - 2- oxo- 2, 5- dihydro- 1H- pyrrole- 1- carboxamide

Clinical data

Trade names

Amaryl, Glimy( Dr Reddy' s)

= monograph

MedlinePlus a696016

Pregnancy

category

US: C ( Risk not ruled out)

Legal status

℞ ( Prescription only)

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 100%

Protein binding >99.5%

Biological half- life 5 hours

Excretion Urine, faeces

Identifiers

CAS Registry Number 93479- 97- 1 Yes

ATC code A10BB12

PubChem CID: 3476

IUPHAR/ BPS 6820

DrugBank DB00222

ChemSpider 16740595 Yes

UNII 6KY687524K Yes

KEGG D00593 Yes

ChEBI CHEBI: 5383

ChEMBL CHEMBL1481 Yes

Chemical data

Formula C24H34N4O5S

Molecular mass 490.617 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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