98% up by HPLC, EP/USP Irbesartan 138402-11-6

Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:98% up by HPLC, EP/USP Irbesartan 138402-11-6
CAS No.:138402-11-6
Standard:USP, BP, EP, JP, In-house Standards
Price(USD):Negotiable
Company:Sinoway Industrial Co.Ltd.

Basic Info
  • Grade: Pharmaceutical Grade

    Factory Location: Xiamen, Fujian

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East

  • Monthly Production Capacity: 1000kg

    Packaging Information: 25kg/drum 1kg/bottle

  • Delivery Lead Time: 7 days after payment

    Sample Provided: yes

    Payment Terms: L/L

     

    Product Information

     

    Product name

    Irbesartan

    CAS No.

    138402-11-6

    Molecular Formula

    C25H28N6O

    Molecular Weight

    428.53

    Quality Standard

    98% up, USP/ EP

    Appearance

    White to almost white powder

     

    COA of Irbesartan

     

    ITEMS

    STANDARDS

    RESULTS

    Appearance

    White to off-white powder

    White powder

     

     

    Identification

    Infrared absorption:

    The IR spectrum is consistent with that obtained with the reference

     

    Conforms

    The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the assay

    Conforms

    Water

    NMT 0.5%

    0.24%

    Limit or Azide

    NMT10ppm

    Not detected

    Heavy metals

    NMT0.002%

    Conforms

    Related compounds

    (HPLC)

    Compound A NMT0.2%

    0.01%

    Any other impurity NMT0.1%

    0.04%

    Total impurity NMT0.5%

    0.09

    Residual solvents(GC)

    Ethanol NMT 5000ppm

    2307 ppm

    Toluene NMT 890ppm

    238 ppm

    Dichloromethane NMT3000 ppm

    Not detected

    N,N-Dimethylformamide NMT880 ppm

    Not detected

    T-butyl Methyl Ether NMT 5000 ppm

    Not detected

    Assay

    98.0—102.0%

    99.2%

    Conclusion

    The analysis results show that this batch of irbesartan conforms to USP

     

    Usage

     

    Function of Irbesartan

    Irbesartan is an angiotensin Ⅱ (Angiotensin Ⅱ, Ang Ⅱ) receptor inhibitor, can inhibit the conversion of Ang Ⅰ to Ang Ⅱ, can specifically antagonize the angiotensin converting enzyme 1 receptor (AT1), the antagonism of AT1 is greater than AT28500 Double, by selectively blocking the binding of AngⅡ and AT1 receptors, inhibiting vasoconstriction and the release of aldosterone, resulting in a hypotensive effect. This product does not inhibit angiotensin converting enzyme (ACE), renin, other hormone receptors, nor does it inhibit ion channels related to blood pressure regulation and sodium balance. It is mainly used for the treatment of essential hypertension and type 2 diabetic nephropathy with hypertension.

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