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Levocetirizine Dihydrochloride Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name LEVOCETIRIZINE DIHYDROCHLORIDE CAS No: 130018- 87- 0

Batch No: LEV/ 011114 A. R. No 14/ FP/ LEV/ 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 or almost white powder.

2. Solubility Complies Freely soluble in water and soluble in methanol.

3. Identification Complies

Complies The I. R. spectrum of sample recorded as KBr

pellet is concordant with similarly recorded

spectrum of working standard.

The light absorption spectrum of a 0.001% wt.

/ vol. solution in methanol in the range of 350nm

to 200nm exhibits maxima at about 230nm.

4. Specific optical rotation +12.9o +10.00o to +14.00º

5. Heavy metals Complies NMT 20 PPM

6. Enantiomeric Purity 99.36% NLT 98.0%

7. Related substances

Individual impurity

Total impurities

0.25%

0.50%

NMT 0.5%

NMT 1.0%

8. Sulphated ash 0.05% NMT 0.20%

9. Loss on drying 0.35% NMT 1.0%

10. Assay 100.4% 98% to 102%

.

Levocetirizine

Levocetirizine structure 2. svg

Ball- and- stick model of the levocetirizine molecule

Systematic ( IUPAC) name

2- ( 2- { 4- [ ( R) - ( 4- chlorophenyl) ( phenyl) methyl] piperazin- 1- yl} ethoxy) acetic acid

Clinical data

Trade names Xyzal

AHFS/ Drugs. com monograph

MedlinePlus a607056

Pregnancy

category

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

Legal status

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability High

Protein binding 90%

Metabolism Hepatic 14% CYP3A4

Biological half- life 6 to 10 hours

Excretion Renal and fecal

Identifiers

CAS Registry Number 130018- 77- 8

ATC code R06AE09

PubChem CID: 1549000

IUPHAR/ BPS 1214

ChemSpider 1266001 Yes

UNII 6U5EA9RT2O Yes

KEGG D07402 Yes

ChEMBL CHEMBL1201191

Chemical data

Formula C21H25ClN2O3

Molecular mass 388.888 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 9, 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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