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| Product information |
Product name | Spironolactone |
Molecular Formula | C24H32O4S |
Molecular Weight | 416.57 |
CAS No. | 52-01-7 |
Quality Standard | CEP/EP9.8 |
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.) | 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 |
Loss on drying | ||
(Ph.Eur.) | Not more than 0.5% | 0.24% |
(USP) | Not more than 0.5% | 0.23% |
Specific optical rotation | ||
(Ph.Eur.) | -41°~-46° | -43.4° |
(USP) | -41°~-45° | -44.3° |
Sulphated ash (Ph.Eur.) | ≤0.1% | 0.02% |
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% | 0.07% |
Any unspecified impurity | ≤0.10% | Complies |
Total | ≤0.7% | 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.) | 97.5%~102.0% | 100.2% |
HPLC (USP) | 97.5%~103.0% | 99.8% |
Residual solvent (In-house) | ||
Methanol | ≤3000ppm | 56ppm |
Tetrahydrofuran | ≤720ppm | ≤LOD (0.0046ppm) |
DMF | ≤880ppm | ≤LOD (0.23ppm) |
Particle size (In-house) | 95% ≤ 20 microns | Complies |
Conclusion | Complies with EP8/USP38 |
Spironolactone API – A High-Purity Potassium-Sparing Diuretic Engineered for Therapeutic Versatility |
As a widely prescribed potassium-sparing diuretic with broad therapeutic indications, Spironolactone plays a key role in treating high blood pressure (Spironolactone blood pressure), heart failure (Spironolactone use in heart failure), acne (Spironolactone for acne), hair loss, and PCOS (Spironolactone for PCOS treatment). We specialize in the industrial-scale production of high-purity Spironolactone API, offering Buy spironolactone API bulk solutions that meet international GMP standards and regulatory filing requirements.
Process Development & Quality Control |
The synthesis of Spironolactone CAS 52-01-7 is based on a steroidal scaffold, with a multi-step route to construct the γ-lactone structure. Key features of our process:
1、Triple esterification and nitrile formation for core ketone and lactone framework with >95% selectivity;
2、Continuous flow reaction technology improves temperature control and conversion rate significantly;
3、Low-temperature recrystallization minimizes by-products and ensures <0.1% residual impurities in line with Spironolactone side effects and benefits expectations.
We implement a full-suite analytical protocol including LC-MS impurity profiling, NMR structural confirmation, and in-process QC aligned with ICH-Q7 and pharmacopoeial specifications.
Application Support & Formulation Value |
Our API supports multiple dosage forms and clinical applications including:
1、Spironolactone tablet formulations in 25mg and 100mg to match demand for Spironolactone 25 mg vs 100 mg dosage comparison;
2、Tailored impurity profiles and purity grades for dermatological use cases like Spironolactone dosage for acne and How does spironolactone work for hair loss;
3、Regulatory support data available for Spironolactone pregnancy safety risk assessment and OTC product registration;
4、Compatibility studies and documentation available for Spironolactone potassium levels monitoring.
We also provide comparative technical sheets to assist formulators evaluating Spironolactone vs hydrochlorothiazide in multi-agent diuretic regimens.
Summary of Process Advantages |
Stage Technical Highlights
Synthesis Route Eco-friendly solvents, 20% higher yield, robust scalability
Impurity Control Total impurities <0.2%, DMF-ready profile
Batch Consistency RSD <1.5% across 5 validated lots
Regulatory Support Full registration documents: DMF, COS, CTD formats
| Product information |
Product name | Spironolactone |
Molecular Formula | C24H32O4S |
Molecular Weight | 416.57 |
CAS No. | 52-01-7 |
Quality Standard | CEP/EP9.8 |
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.) | 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 |
Loss on drying | ||
(Ph.Eur.) | Not more than 0.5% | 0.24% |
(USP) | Not more than 0.5% | 0.23% |
Specific optical rotation | ||
(Ph.Eur.) | -41°~-46° | -43.4° |
(USP) | -41°~-45° | -44.3° |
Sulphated ash (Ph.Eur.) | ≤0.1% | 0.02% |
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% | 0.07% |
Any unspecified impurity | ≤0.10% | Complies |
Total | ≤0.7% | 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.) | 97.5%~102.0% | 100.2% |
HPLC (USP) | 97.5%~103.0% | 99.8% |
Residual solvent (In-house) | ||
Methanol | ≤3000ppm | 56ppm |
Tetrahydrofuran | ≤720ppm | ≤LOD (0.0046ppm) |
DMF | ≤880ppm | ≤LOD (0.23ppm) |
Particle size (In-house) | 95% ≤ 20 microns | Complies |
Conclusion | Complies with EP8/USP38 |
Spironolactone API – A High-Purity Potassium-Sparing Diuretic Engineered for Therapeutic Versatility |
As a widely prescribed potassium-sparing diuretic with broad therapeutic indications, Spironolactone plays a key role in treating high blood pressure (Spironolactone blood pressure), heart failure (Spironolactone use in heart failure), acne (Spironolactone for acne), hair loss, and PCOS (Spironolactone for PCOS treatment). We specialize in the industrial-scale production of high-purity Spironolactone API, offering Buy spironolactone API bulk solutions that meet international GMP standards and regulatory filing requirements.
Process Development & Quality Control |
The synthesis of Spironolactone CAS 52-01-7 is based on a steroidal scaffold, with a multi-step route to construct the γ-lactone structure. Key features of our process:
1、Triple esterification and nitrile formation for core ketone and lactone framework with >95% selectivity;
2、Continuous flow reaction technology improves temperature control and conversion rate significantly;
3、Low-temperature recrystallization minimizes by-products and ensures <0.1% residual impurities in line with Spironolactone side effects and benefits expectations.
We implement a full-suite analytical protocol including LC-MS impurity profiling, NMR structural confirmation, and in-process QC aligned with ICH-Q7 and pharmacopoeial specifications.
Application Support & Formulation Value |
Our API supports multiple dosage forms and clinical applications including:
1、Spironolactone tablet formulations in 25mg and 100mg to match demand for Spironolactone 25 mg vs 100 mg dosage comparison;
2、Tailored impurity profiles and purity grades for dermatological use cases like Spironolactone dosage for acne and How does spironolactone work for hair loss;
3、Regulatory support data available for Spironolactone pregnancy safety risk assessment and OTC product registration;
4、Compatibility studies and documentation available for Spironolactone potassium levels monitoring.
We also provide comparative technical sheets to assist formulators evaluating Spironolactone vs hydrochlorothiazide in multi-agent diuretic regimens.
Summary of Process Advantages |
Stage Technical Highlights
Synthesis Route Eco-friendly solvents, 20% higher yield, robust scalability
Impurity Control Total impurities <0.2%, DMF-ready profile
Batch Consistency RSD <1.5% across 5 validated lots
Regulatory Support Full registration documents: DMF, COS, CTD formats
