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Candesartan Cilexetil Usp Ip Bp Ep Manufaturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Candesartan cilexetil CAS No:

Batch No: CAN/ 011114 A. R. No 14/ FP/ CAN/ 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 crystal powder

2. Identification Complies IR: similar to standard

UV: similar to standard max at 255±2nm

3 Solubility Complies Very soluble in chloroform.

Slightly soluble in methanol.

Insoluble in water.

4. Loss On Drying 0.11% NMT 1.50%

5. Melting point 161.7℃ to 163.5℃ 160℃ to 166℃

6. Residue On Ignition 0.03% NMT 0.1%

7. Heavy metals Complies NMT 20 PPM

8. Particle size Complies 80% NLT 125u

9. Total Microbial Count Complies NMT 100 cfu/ gm

10. Enterabacteriaceae Complies NMT 10 cfu/ gm

11. Fungal count Complies NMT 10 cfu/ gm

12. 1 gm is free from Complies Staph aureus

13. 10 gm Complies E. coli

14. Ps. aeruginosa Complies Negative

15. Salmonella spp Complies Negative

16. Related Impurities

Total impurities

Candesartan

Ethyleste candesartan

Desethyl candesartan cilexetil

Triphenyl methanol

Any other unknown impurity

0.2%

0.05%

0.03%

0.06%

0.03%

NMT 0.2%

NMT 0.1%

17. Assay 99.80% 98.0% to 102.0%

.

Candesartan. svg

Systematic ( IUPAC) name

2- ethoxy- 1- ( { 4- [ 2- ( 2H- 1, 2, 3, 4- tetrazol- 5- yl) phenyl] phenyl} methyl) - 1H- 1, 3- benzodiazole- 7- carboxylic acid

Clinical data

Trade names Atacand

AHFS/ Drugs. com monograph

MedlinePlus a601033

Pregnancy

category

AU: D

Legal status

℞ ( Prescription only)

Routes of

administration oral

Pharmacokinetic data

Bioavailability 15% ( candesartan cilexetil)

Metabolism Candesartan cilexetil: intestinal wall; candesartan: hepatic ( CYP2C9)

Biological half- life 9 hours

Excretion Renal 33% , faecal 67%

Identifiers

CAS Registry Number 139481- 59- 7 Yes

ATC code C09CA06

PubChem CID: 2541

IUPHAR/ BPS 587

DrugBank DB00796 Yes

ChemSpider 2445 Yes

UNII S8Q36MD2XX Yes

KEGG D00626

ChEBI CHEBI: 3347 Yes

ChEMBL CHEMBL1016 Yes

Chemical data

Formula C24H20N6O3

Molecular mass 440.45 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 5, 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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