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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 +14.00ยบ

    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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