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Vildagliptin Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Vildagliptin CAS No: 274901- 16- 5

Batch No: VIL/ 011114 A. R. No 14/ FP/ VIL/ 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. Assay 99.23 NLT 99.0%

3. Residue on ignition 0.08% NMT 0.10%

4. Solvent residue 930ppm Isopropanol ≤ 5000ppm

5. Melting point 148.6ºC to 149.5ºC 148ºC to 150ºC

6. Total impurities 0.32% NMT 1.0%

7. Water 0.26% NMT 0.50%

Skeletal formula

Ball- and- stick model

Systematic ( IUPAC) name

( S) - 1- [ N- ( 3- hydroxy- 1- adamantyl) glycyl] pyrrolidine- 2- carbonitrile

Clinical data

Trade names Galvus

AHFS/ Drugs. com International Drug Names

Licence data EMA: Link

Pregnancy

category

Not recommended

Legal status

UK: Prescription- only ( POM)

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 85%

Protein binding 9.3%

Metabolism Mainly hydrolysis to inactive metabolite; CYP450 not appreciably involved

Biological half- life 2 to 3 hours

Excretion Renal

Identifiers

CAS Registry Number 274901- 16- 5

ATC code A10BH02

A10BD08 ( with metformin) [ 1]

PubChem CID: 6918537

IUPHAR/ BPS 6310

DrugBank DB04876 Yes

ChemSpider 5293734 Yes

UNII I6B4B2U96P Yes

KEGG D07080 Yes

ChEMBL CHEMBL142703 Yes

Synonyms ( 2S) - 1- { 2- [ ( 3- hydroxy- 1- adamantyl) amino] acetyl} pyrrolidine- 2- carbonitrile

Chemical data

Formula C17H25N3O2

Molecular mass 303.399 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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