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  • Emedastine Difumarate Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Emedastine Difumarate USP CAS No: 87233- 62- 3

    Batch No: EME/ 030313 A. R. No 13/ FP/ EME/ 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 a) By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

    Complies b) By HPLC: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.

    4. Related Substances

    Individual Impurity Total Impurity

    0.09%

    0.56%

    NMT 0.3%

    NMT 1.0%

    5. pH 3.4 Between 3.0–4.5

    6. Loss on drying NMT 0.5%

    7. Heavy Metals Complies 20ppm

    8. Residue On Ignition 0.03% NMT 0.1%

    9. Assay 99.3% 98.5% –101.0%

    Loratadine

    Loratadine. svg

    Loratadine - 3d, portrait orientation. png

    Systematic ( IUPAC) name

    Ethyl 4- ( 8- chloro- 5, 6- dihydro- 11H- benzo[ 5, 6] cyclohepta[ 1, 2- b] pyridin- 11- ylidene) - 1- piperidinecarboxylate

    Clinical data

    Trade names Claritin

    AHFS/ Drugs. com monograph

    MedlinePlus a697038

    Pregnancy

    category

    AU: B1

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

    Legal status

    CA: OTC

    UK: General sales list ( GSL, OTC)

    US: OTC

    Routes of

    administration oral

    Pharmacokinetic data

    Bioavailability almost 100%

    Protein binding 97–99%

    Metabolism Hepatic ( CYP2D6- and 3A4- mediated)

    Biological half- life 8 hours, active metabolite desloratadine 27 hours

    Excretion 40% as conjugated metabolites into urine

    Similar amount into the feces

    Identifiers

    CAS Registry Number 79794- 75- 5 Yes

    ATC code R06AX13

    PubChem CID: 3957

    IUPHAR/ BPS 7216

    DrugBank DB00455

    ChemSpider 3820 Yes

    UNII 7AJO3BO7QN Yes

    KEGG D00364 Yes

    ChEMBL CHEMBL998 Yes

    Chemical data

    Formula C22H23ClN2O2

    Molecular mass 382.88 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 7, 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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