EP8; USP38, 99% up by HPLC Spironolactone 52-01-7

Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:EP8; USP38, 99% up by HPLC Spironolactone 52-01-7
CAS No.:52-01-7
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

    Spironolactone

    Molecular Formula

    C24H32O4S

    Molecular Weight

    416.57

    CAS No.

    52-01-7

    Quality Standard

    99% up, medical grade

    Appearance

    White powder

     

    COA of Spironolactone

     

    ITEMS

    STANDARDS

    RESULTS

    Appearance (Ph.Eur.)

    A white or yellowish-white powder

    White powder

    Solubility (Ph.Eur.)

    Practically insoluble in water, soluble in ethanol (96%)

    Complies

    Identification

    A.    IR –spectrum (Ph.Eur.)

    A.  IR –spectrum (USP)

    B.    TLC (Ph.Eur.)

    B.  UV absorption (USP)

    C.    Colour reaction (Ph.Eur.)

    C.  Precipitate reaction (USP)

    Meet the requirement

    Meet the requirement

    Meet the requirement

    Meet the requirement

    Meet the requirement

    Meet the requirement

    Complies

    Complies

    Complies

    Complies

    Complies

    Complies

    Loss on drying

    (Ph.Eur.)

    (USP)

     

    Not more than 0.5%

    Not more than 0.5%

     

    0.24%

    0.23%

    Specific optical rotation

    (Ph.Eur.)

    (USP)

     

    -41°~-46°

    -41°~-45°

     

    -43.4°

    -44.3°

    Sulphated ash (Ph.Eur.)

    ≤0.1%

    0.02%

    Related substances (Ph.Eur.)

    Impurity A

    Impurity B

    Impurity C

    Impurity D

    Impurity E

    Impurity I

    Any unspecified impurity

    Total

    ≤0.2%

    ≤0.3%

    ≤0.2%

    ≤0.15%

    ≤0.3%

    ≤0.5%

    ≤0.10%

    ≤0.7%

    N.D.

    N.D.

    N.D.

    N.D.

    N.D.

    0.07%

    Complies

    0.16%

    Ordinary impurities (USP)

    ≤2.0%

    Complies

    Free thiol compounds (Ph.Eur.)

    ≤0.05mL

    Complies

    Free mercapto compounds (USP)

    ≤0.10mL

    Complies

    Chromium (Ph.Eur.)

    ≤50ppm

    Complies

    Assay

    HPLC (Ph.Eur.)

    HPLC (USP)

     

    97.5%~102.0%

    97.5%~103.0%

     

    100.2%

    99.8%

    Residual solvent (In-house)

    Methanol

    Tetrahydrofuran

    DMF

     

    ≤3000ppm

    ≤720ppm

    ≤880ppm

     

    56ppm

    ≤LOD (0.0046ppm)

    ≤LOD (0.23ppm)

    Particle size (In-house)

    95% ≤ 20 microns

    Complies

    Conclusion

    Compiles with EP8/USP38

     

    Usage

     

    Function of Spironolactone

     

    Spironolactone is a steroid and is a strong endogenous salt corticosteroid aldosterone. Spironolactone has a similar chemical structure to aldosterone. It competes with aldosterone in the epithelial cells of the cortical segment of the distal convoluted tubule and collecting duct to bind to the aldosterone receptor, thereby inhibiting the effect of aldosterone in promoting K-Na exchange. Increase the excretion of Na and Cl, play a diuretic effect, while K is retained. The drug has a weak diuretic effect, slow and lasting. After a period of continuous medication, its diuretic effect gradually weakened. At the same time, it has anti-androgen activity, which can selectively destroy the testis and adrenal microsomal cytochrome P450, thereby inhibiting the production of androgens in the gonads, and can compete with dihydrotestosterone for receptors in the target tissues, reducing the stimulation of androgens to the sebaceous gland.


    1. Edema diseases: spironolactone is used in combination with other diuretics to treat edema diseases such as congestive edema, liver cirrhosis, ascites, and renal edema. The purpose is to correct the secondary aldosterone secretion associated with the above diseases, and to combat other diuretics The role of potassium excretion. It is also used for the treatment of idiopathic edema.

    2. Hypertension effect: Spironolactone is an auxiliary drug for the treatment of hypertension.

    3. Primary aldosteronism: Spironolactone can be used for the diagnosis and treatment of this disease.

    4. Prevention of hypokalemia: Combination of spironolactone and thiazide diuretics can enhance the diuretic effect and prevent hypokalemia.

    Clinically, spironolactone is used to treat refractory edema related to elevated aldosterone, so it is more effective for patients with cirrhosis and nephrotic syndrome, but for congestive heart failure unless secondary hyperaldosteronism is caused by sodium deficiency. , The effect is poor.

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