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Powder: | Yes |
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Product Name:Degarelix CAS NO:214766-78-6 Mf:C27h40n8o7 Active ingredients:Degarelix Testing Method:HPLC Use:Chemical and Pharmaceutical Intermediates Appearance: White fine powder Type:Pharmaceutical Intermediates Shelf Life:2 Years When Properly Stored Storage: Keep in a cool, dry, dark location in a tightly sealed container or cylinder. |
Degarelix (INN) or degarelix acetate (USAN) (tradename Firmagon) is a hormonal therapy used in the treatment of prostate cancer. During development it was known as FE200486.
Testo sterone is a male hormone that promotes growth of many prostate tumours and therefore reducing circulating testo sterone to very low (castration) levels is often the treatment goal in the management of advanced prostate cancer. Degarelix has an immediate onset of action, binding to gonadotropin-releasing hormone (GnRH) receptors in the pituitary gland and blocking their interaction with GnRH. This induces a fast and profound reduction in luteinising hormone (LH), follicle-stimulating hormone (FSH) and in turn, testo sterone suppression.
-Treatment of postmenopausal women with osteoporosis at high risk for fracture
-Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture
-Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture
Item | Standard | Test Results | |
Identification | A.H-NMR:Comply with the structure | Complies | |
B.LC-MS:Comply with the structure | Complies | ||
C.The IR spectrum of sample should be identical with that of reference standard; | Complies | ||
D.HPLC-ESI-MS | Complies | ||
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. | |||
Heavy metals | ≤10 ppm | <10ppm | |
Water | ≤1.0% | 0.10% | |
Sulphated ash | ≤0.5%, determined on 1.0 g. | 0.01% | |
Related substances | Unspecified impurities: for each impurity | ≤0.10% | <0.10% |
Total Impurity | ≤0.5% | 0.18% | |
Purity | ≥99.0% | 99.70% | |
Assay | 99.0%~101.0% (anhydrous substance). | 99.80% | |
Storage | Preserve in well-closed, light-resistant and airtight containers. | Complie |
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