Product Details
It is a synthetic 17-lactone drug that is a renal competitive aldosterone antagonist in a class of pharmaceuticals called potassium-sparing diuretics, used primarily to treat heart failure, ascites in patients with liver disease, low-renin hypertension, hypokalemia, secondary hyperaldosteronism (such as occurs with hepatic cirrhosis), and Conn's syndrome (primary hyperaldosteronism). On its own, spironolactone is only a weak diuretic because its effects target the distal nephron (collecting tubule), where urine volume can only be slightly modified; but it can be combined with other diuretics to increase efficacy. About one person in one hundred with hypertension has elevated levels of aldosterone; in these persons, the antihypertensive effect of spironolactone may exceed that of complex combined regimens of other antihypertensives. Due to its antiandrogen effect, it can also be used to treat hirsutism. It is also used for treating hair loss and acne in women, and can be used as a topical medication for treatment of male baldness. It is commonly used to treat symptoms of polycystic ovary syndrome (PCOS) such as excess facial hair and acne. It can also cause gynecomastia in males and should never be given with potassium supplementation for fear of the development of hyperkalemia.
| 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.) | Meet the requirement | Complies |
A. IR –spectrum (USP) | Meet the requirement | Complies |
B. TLC (Ph.Eur.) | Meet the requirement | Complies |
B. UV absorption (USP) | Meet the requirement | Complies |
C. Colour reaction (Ph.Eur.) | Meet the requirement | Complies |
C. Precipitate reaction (USP) | Meet the requirement | Complies |
Specific optical rotation | -41°~-46° | -42.8° |
(Ph.Eur.) | -41°~-45° | -42.9° |
(USP) |
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Sulphated ash (Ph.Eur.) | ≤0.1% | 0.00% |
Related substances (Ph.Eur.) | ||
Impurity A | ≤0.2% | N.D. |
Impurity B | ≤0.3% | N.D. |
Impurity C | ≤0.2% | N.D. |
Impurity D | ≤0.15% | N.D. |
Impurity E | ≤0.3% | N.D. |
Impurity I | ≤0.5% | 0.05% |
Any unspecified impurity | ≤0.10% | Complies |
Total | ≤0.7% | 0.13% |
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 | 97.5%~102.0% | 100.90% |
HPLC (Ph.Eur.) | 97.5%~103.0% | 99.60% |
HPLC (USP) |
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Residual solvent (In-house) | ≤3000ppm | 90ppm |
Methanol | ≤720ppm | ≤LOD (0.0046ppm) |
Tetrahydrofuran | ≤880ppm | ≤LOD (0.23ppm) |
DMF |
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Particle size (In-house) | 95% ≤ 20 microns | Complies |
Conclusion | Compiles with EP7/USP35 | |
Spironolactone
25kg/Fiber Drum (35 cm* 53 cm), Double plastic bag inside;
1Kg/Aluminum foil bag, with single plastic inside, and carton outside;
And other package, or as your requirements.
Spironolactone
Delivery: Sea/ Air Shipping & International Express
Shipping Time: 2-3 working days after payment
Storage: Kept away from strong light and heat.
Shelf Life: 24 months
Q1: Are you manufacturer or trading company for Spironolactone?
A:We are trader with ISO22000,Kosher,Halal,HACCP certified over 10 years.
Q2:How can we guarantee you receive a good quality ?
A: Our own factory comply to GMP standard and run with strict quality control,every batch of the product must be tested and ensure the quality before shipment.
Q3: What’s the delivery and shipping ?
A:For sample,around 1-3days to be sent out upon receipt of payment by
DHL,Fedex,TNT,UPS,EMS or SF.
For small order, please expect 3-7days by DHL. FedEx,TNT,UPS EMS or SF.
For bulk order, around 2 weeks to finish production from order confirmation,will be delivered by air or sea as customer requested.
Q4: Can I get some sample to test the quality?
A: Of course you can, a 20g-30g free sample is available for you to test.
Q5: What’s the payment?
A: We accept T/T,L/C,D/A,D/P,Western Union,Paypal.
Q6:What is your package and storage?
A:25kg per paper drum with double layer poly bag inside.
Store in cool and dry place, keep away from strong light and heat.
Q7:What is your return service policy?
A: We offer a 45days guarantee on receipt of goods without any damage to packing. We will return your money if our products don’t conform to your approved quality.
