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Ursodiol Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Ursodiol USP CAS No: 128- 13- 2

Batch No: URS/ 030313 A. R. No 13/ FP/ URS/ 0303

Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

Batch Quantity 165 kg Date of Retest Jan- 2016

Sr. No Test Results Acceptance Criteria

1. Appearance

2. Solubility

3. Identification

Complies By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

4. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) 58º Between 57°–62°

5. Loss on drying 0.21% NMT 0.5%

6. Heavy Metals Complies 10ppm

7. Residue On Ignition 0.08% NMT 0.1%

8. Assay HPLC 99.29% 98.5% –101.5%

9. Melting Temperature 201º 200°–205°

Ursodeoxycholic acid

Ursodeoxycholic acid acsv. svg

Ursodeoxycholic acid ball- and- stick. png

Systematic ( IUPAC) name

3α , 7β - dihydroxy- 5β - cholan- 24- oic acid

OR

( R) - 4- ( ( 3R, 5S, 7S, 8R, 9S, 10S, 13R, 14S, 17R) - 3, 7- dihydroxy-

10, 13- dimethylhexadecahydro-

1H- cyclopenta[ a] phenanthren- 17- yl) pentanoic acid

Clinical data

Trade names Actigall

AHFS/ Drugs. com monograph

MedlinePlus a699047

Licence data US Daily Med: link

Pregnancy

category

AU: B3

US: B ( No risk in non- human studies)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration oral

Identifiers

CAS Registry Number 128- 13- 2 Yes

ATC code A05AA02

PubChem CID: 31401

IUPHAR/ BPS 7104

DrugBank DB01586 Yes

ChemSpider 29131 Yes

UNII 724L30Y2QR Yes

KEGG D00734 Yes

ChEBI CHEBI: 9907 Yes

ChEMBL CHEMBL1551 Yes

Synonyms ursodeoxycholic acid, Actigall, Ursosan, Urso, Urso Forte

PDB ligand ID IU5 ( PDBe, RCSB PDB)

Chemical data

Formula C24H40O4

Molecular mass 392.56 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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