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  • Amlodopinebesilate Api Bulk Drugs Manufacturer Supplier - India

    price: contact company for price


    Product Name Amlodopinebesilate CAS No:

    Batch No: AML/ 011114 A. R. No 14/ FP/ AML/ 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 crystalline powder

    2. Identification




    IR spectrum should be concordant with the amlodipine

    besilate working standard

    The Principal spot in the chromatogram obtained with the

    test solution ( b) corresponds to that in the chromatogram

    obtained with reference solution ( b) by TLC in test A for

    related substances.

    The specific absorbance at the maximum is 113 to 121

    IR spectrum concordant with the Amlodipine besilate

    working standard.

    Matching the standard

    Meet the requirement

    3. Solubility Complies Slightly soluble

    in water freely soluble in methanol sparingly soluble in

    ethanol slightly soluble in 2- propanol

    4. Optical rotation 0.00° - 0.10° to +0.10°

    determined in a 1.0% w/ v solution in methanol

    5. Relative substances

    A by TLC

    Total Impurity

    Number of spots of >0.10% and <0.30%

    B by HPLC

    Impurity D

    Total impurities



    BDL ( 0.03% )


    NMT 0.3%

    NMT 2 spot

    NMT 0.30%

    6. Sulphated ash 0.06% NMT 0.20% w/ w

    7. Water content 0.09% NMT 0.50% w/ w

    8. Assay by HPLC 99.59% 97.0% to 102.0% w/ w on

    anhydrous basis

    9. Residual solvents



    Ethyl acetate


    3.96 PPM

    0.59 PPM

    3.07 PPM

    1.4 PPM

    NMT 1000 PPM

    NMT 290 PPM

    NMT 500 PPM

    Company Contact:

    • Phone: 917387999183


    • Email: Email

    Published date: April 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. Our warehouse facilities is approved by FDA and ISO 9001:2008 Certified and we are specializes in sales and marketing of Pharmaceutical Finished products, Pharmaceutical Active Ingredients (API's), Intermediates and Herbal Extracts, 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.
      Send us your enquiries on Email: sales@swapnroopdrugs.com
      or Call us on Tel: +91 240 6641875, Mob:+91 7387999183
      Contact Persons:
      1. Dulal Mohato (Sales & Marketing Manager) Tel:0240 6641875, Mob:+91 7387999183
      Email: sales@swapnroopdrugs.com Whatsapp Mobile No: +91 7387999183
      Skype: dulalmohato

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