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Cinacalcet Hcl Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Cinacalcet HCl CAS No: 364782- 34- 3

Batch No: CIN/ 011114 A. R. No 14/ FP/ CIN/ 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

2. Identification Complies HPLC retention time

3. Purity 99.7% NLT 99.5%

4. Total impurity 0.10% NMT 0.5%

5. Individual impurity 0.05% NMT 0.3%

6. Heavy metals 8 PPM NMT 20 PPM

7. Water content 0.2% NMT 1.0%

8. Residue on ignition 0.03% NMT 0.1%

9. Assay 99.3% 98.5% to 101.0%

Cinacalcet

Cinacalcet Structural Formulae. png

Cinacalcet ball- and- stick. png

Systematic ( IUPAC) name

( R) - N- [ 1- ( 1- naphthyl) ethyl] - 3-

[ 3- ( trifluoromethyl) phenyl] propan- 1- amine

Clinical data

AHFS/ Drugs. com monograph

MedlinePlus a605004

Licence data EMA: Link, US FDA: link

Pregnancy

category

AU: B3

US: C ( Risk not ruled out)

Legal status

℞ ( Prescription only)

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 20 to 25%

Increases if taken with food

Protein binding 93 to 97%

Metabolism Hepatic ( CYP3A4- , CYP2D6- and CYP1A2- mediated)

Biological half- life 30 to 40 hours

Excretion Renal ( 80% ) and fecal ( 15% )

Identifiers

CAS Registry Number 226256- 56- 0 Yes

ATC code H05BX01

PubChem CID: 156419

IUPHAR/ BPS 3308

DrugBank DB01012 Yes

ChemSpider 137743 Yes

UNII UAZ6V7728S Yes

KEGG D03504 Yes

ChEBI CHEBI: 48390 Yes

ChEMBL CHEMBL1201284

Chemical data

Formula C22H22F3N

Molecular mass 357.412 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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