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Ibuprofen tablet

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SKU:FFT007
Description:

Quick Details

Specifications

Ibuprofen 
Chinese GMP certificate 
OEM produciton 
Support for registration 
Digemid GMP 



    Name:Ibuprofen 
    MF:C13H18O2

    CAS No:15687-27-1

    EINECS:239-784-6

    Medicine grade

    Quality standard:USP/BP

    200/400/600/800mg

    With US DMF:15839,CEP:2002-099,Canada DMF:2006-216.

    Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used for relief of symptoms of arthritis, fever, as an analgesic (pain reliever), especially where there is an inflammatory component, and dysmenorrhea.

    Ibuprofen is known to have an antiplatelet effect, though it is relatively mild and short-lived when compared with aspirin or other better-known antiplatelet drugs. In general, ibuprofen also acts as a vasodilator, having been shown to dilate coronary arteries and some other blood vessels. Ibuprofen is a core medicine in the World Health Organization's "WHO Model List of Essential Medicines", which is a list of minimum medical needs for a basic healthcare system.


    ITEMS

    SPECIFICATIONS

    RESULTS

    Appearance

    White, crystalline powder or colorless crystals

    Passes

    Identification

    Accord With BP2007

    Passes

    Assay

    98.5%~101.0%

    99.97%

    Melting point

    75°C~78°C

    77°C

    Optical rotation

    -0.05°~+0.05°

    0.00°

    Heavy metals

    ≤ 0.001%

    <0.001%

    Related substances

    Impurity B

    ≤ 0.3%

    Passes

    Any other impurity

    ≤ 0.3%

    Passes

    Total of all impurities apart from impurity B

    ≤ 0.7%

    Passes

    Impurity F

    ≤ 0.1%

    Not detected

    Sulphated ash

    ≤ 0.1%

    0.02%

    Appearance of solution

    Accord With BP2007

    Passes

    Conclusion: COMPLY WITH BP2007



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