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1 / Spiramycin
2 / CAS No 8025-81-8
3 / MF No C43H74N2O14
4 / Quality Standard USP/EP/B
5 / EINECS No 232-429-6
Finasteride is used for the treatment of benign prostatic hyperplasia (BPH) and male pattern baldness (MPB).
Benign prostatic hyperplasiaPhysicians use Finasteride for the treatment of benign prostatic hyperplasia (BPH) (also known as enlarged prostate) at a dose of 5 mg once a day. Six months or more of treatment may be required to see the full effects of finasteride. If the drug is discontinued, any therapeutic benefits will be reversed. Finasteride may improve the symptoms associated with BPH such as difficulty urinating, getting up during the night to urinate, hesitation at the start of urination, and decreased urinary flow.[1]
Item | Standard | Test Result |
Characteristics | A slightly yellowish or white powder | Conform |
Solubility | Slightly soluble in water, freely soluble in acetone in ethanol(96%) and in methanol | Conform |
Identification | UV spectrum according to EP6.1 | Conform |
| TLC according to EP6.1 | Conform |
| Colorimetric test according to EP6.1 | Conform |
PH | 8.5~10.5 | 9.7 |
Specific optical rotation | -85°~-80° | -81° |
Loss on drying | ≤3.5% | 0.019 |
Heavy Metals | ≤20ppm | Conform |
Related Substances | Impurity A ≤2.0% | 0.011 |
| Impurity B ≤2.0% | 0.013 |
| Impurity C ≤2.0% | Conform |
| Impurity D ≤2.0 | Conform |
| Impurity E ≤2.0% | Conform |
| Impurity F ≤2.0% | 0.014 |
| Impurity G ≤2.0% | Conform |
| Impurity H ≤2.0% | Conform |
| Any other impurity ≤2.0% | 0.21%,0.27%,0.24%,0.16%, |
|
| 0.29%,0.54%,0.42%,0.11% |
|
| 0.33%,0.14% |
| Total impurities ≤10.0% | 0.05 |
Sulphated Ash | ≤0.1% | 0.0007 |
Butyl acetate | ≤5000ppm | 200ppm |
Composition | Spiramycin I ≥80.0% | 0.941 |
| Spiramycin II≥5.0% | 0.001 |
| Spiramycin III≥10.0% | 0.006 |
| Total Spiramycin I,II,III≥90.0% | 0.948 |
Assay | ≥4100iu/mg calculated with reference to the anhydrous substances | 4780iu/mg |
