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Urwego rwa GMP Degarelix acetate API hamwe na dosiye ya DMF

Ibisobanuro bigufi:

DMF irahari kuri Degarelix acetate API. Niba ufite ikibazo, nyamuneka twohereze iperereza, tuzagusubiza.


Ibicuruzwa birambuye

Ibicuruzwa

Ibisobanuro byihuse

Izina rusange: Degarelix acetate
Cas No.: 214766-78-6
Inzira ya molekulari: C82H103ClN18O16
Uburemere bwa molekile: 1632.28 g / mol
Urukurikirane: Ac-D-2-Nal-D-4-Cpa-D-3-Pal-Ser-4-amino-Phe (L-hydroorotyl) -4-ureido- D-Phe-Leu-Lys (isopropyl) -Pro- D-Ala-NH2 umunyu wa acetate
Kugaragara: Ifu yera
Gusaba: Degarelix acetate ni imiti ikoreshwa mu kuvura kanseri ya prostate. Ni mubyiciro byibiyobyabwenge bita gonadotropin-isohora imisemburo (GnRH) antagonist. Bitandukanye na GnRH agoniste, ibanza gutera umusaruro wa testosterone hanyuma ikagabanya testosterone, acetate ya degarelix ihagarika byimazeyo ibikorwa bya GnRH, bityo bikagabanya urugero rwa testosterone mumubiri. Mugabanye urugero rwa testosterone, acetate ya degarelix ifasha gutinda gukura kwingirangingo za kanseri ya prostate. Yatewe munsi y'uruhu rimwe mu kwezi. Degarelix acetate yagaragaye ko ifite akamaro mukugabanya vuba urugero rwa testosterone no kuyikomeza murwego rusabwa kugirango ivure kanseri ya prostate. Degarelix acetate ni uburyo bwingenzi bwo kuvura kubagabo barwaye kanseri ya prostate idashobora cyangwa badashaka kubagwa cyangwa gufata imiti yo mu kanwa igabanya urugero rwa testosterone. Mubisanzwe byihanganirwa neza, kandi ingaruka zisanzwe zirimo gutera inshinge, kubira ibyuya, gushyuha, no kugabanuka kwa libido. Muri rusange, acetate ya degarelix ni uburyo bwiza kandi bufatika bwo kuvura kanseri ya prostate yateye imbere, ifasha mu kurwanya indwara no kuzamura imibereho y’umurwayi.
Ipaki: aluminium foil umufuka cyangwa aluminium TIN cyangwa nkuko umukiriya abisabwa

Ibyiza byacu

1

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2

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3

GMP na DMF birahari hamwe nibyangombwa byizewe.

Ibibazo

Ikibazo: Urashobora gupakira ibicuruzwa nkuko tubisabwa?

Igisubizo: Yego, turashobora gupakira nkuko ubisabwa.

Ikibazo: Igihe cyo kwishyura ni ikihe?

Igisubizo: LC kureba na TT mbere yigihe cyo kwishyura byatoranijwe.

Ikibazo: Urashobora kugenzura ubuziranenge ukurikije isosiyete yacu mubisobanuro byinzu?

Igisubizo: Yego, nyamuneka tanga ibisobanuro byawe byiza, tuzagenzura hamwe na R&D hanyuma tugerageze guhuza ubuziranenge bwawe.


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