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Repaglinide Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name REPAGLINIDE CAS No:

Batch No: REP/ 011114 A. R. No 14/ FP/ REP/ 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. Identification + 6.7° Rotation +6.3° to +7.7°

3. RS correspond to the reference substance Should correspond to the RS infrared absorption

4. Related substance

Individual impurity

Total impurity

0.05%

0.14%

NMT 0.1%

NMT 0.5%

5. Enantiomeric impurity Not detected NMT 0.2%

6. Dichlormethane

Ethanol

Methanol Not detected

Not detected

Not detected NMT 0.06%

NMT 0.3%

7. Assay 100.1% 99.0% to 101.0%

8. Residue on ignition Complies NMT 0.1%

9. Loss on drying 0.06% NMT 0.5%

Repaglinide

Repaglinide. svg

Repaglinide ball- and- stick. png

Systematic ( IUPAC) name

( S) - ( +) - 2- ethoxy- 4- [ 2- ( 3- methyl- 1- [ 2- ( piperidin- 1- yl) phenyl] butylamino) - 2- oxoethyl] benzoic acid

Clinical data

Trade names Prandin

AHFS/ Drugs. com monograph

MedlinePlus a600010

Licence data EMA: Link, US FDA: link

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

Pharmacokinetic data

Bioavailability 56% ( oral)

Protein binding >98%

Metabolism Hepatic oxidation and glucuronidation ( CYP3A4- mediated)

Biological half- life 1 hour

Excretion Fecal ( 90% ) and renal ( 8% )

Identifiers

CAS Registry Number 135062- 02- 1 Yes

ATC code A10BX02

PubChem CID: 65981

IUPHAR/ BPS 6841

DrugBank DB00912 Yes

ChemSpider 59377 Yes

UNII 668Z8C33LU Yes

KEGG D00594 Yes

ChEMBL CHEMBL1272 Yes

Chemical data

Formula C27H36N2O4

Molecular mass 452.586 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 14, 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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