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Carvedilol《EP10.2》的藥典標(biāo)準(zhǔn)一份，最新版本的，卡維地洛原料藥相關(guān)的全部?jī)?nèi)容。   [更多]

尼達(dá)尼布軟膠囊注冊(cè)標(biāo)準(zhǔn) 最好PDF版本   [更多]

需要標(biāo)準(zhǔn)，有意愿開發(fā)   [更多]

具體要求： 辦理第一類醫(yī)療器械產(chǎn)品備案所需材料： 1、第一類醫(yī)療器械備案表 2.產(chǎn)品風(fēng)險(xiǎn)分析資料 3.產(chǎn)品技術(shù)要求 4.產(chǎn)品檢驗(yàn)報(bào)告 5.臨床評(píng)價(jià)資料 6.生產(chǎn)制造信息 7.產(chǎn)品說明書及最小銷售單元標(biāo)簽設(shè)計(jì)樣稿 8.證明性文件 9.符合性聲明   [更多]

求購HypromelloseCapsules《JP17(英)》的藥典標(biāo)準(zhǔn)一份   [更多]

請(qǐng)?zhí)峁┮环菀阴＿虬菲乃幍錁?biāo)準(zhǔn)一份 最新的即可   [更多]

https://journal.pda.org/content/41/3/88.short 要求完整的版本。   [更多]

1.Title：Studies of the polymorphism of sodium valproate. (Ger.). Authors：Kleinebudde P; Thies R Publication Name：Sci.Pharm. Publication Year：1999 Keywords：Valproate Sodium/Oc Crystal/Ft Polymorphism/Ft Calorimetry/Ft X-Ray- Diffraction/Ft Analysis/Ft Crystallography/Ft Anticonvulsants/Ft Antimanics / Ft Oc / Ft Extract：2 Crystal modifications (M1 and M2) of Na valproate (NV) have been detected at RT, while a further form (M3) occurred at temperatures above 100 deg. Untreated NV, which had been recrystallized from toluene or ethyl acetate occurred as modification M1. These modifications were examined by thermoanalytical (DSC, thermogravimetry) and X-ray crystallographic methods. 2.【題名】Polymorphism of sodium valproate 【作 者】Mifsud, H.;Miguel, L.;Lavastre, V.;Maire, G. 【刊 名】Calorim. Anal. Therm. Calorimetrie et Analyse Thermique 【出版日期】1993 【卷 號(hào)】Vol.24 【頁 碼】309-312 【關(guān)鍵詞】polymorphism sodium valproate Polymorphism of sodium valproate 1069-66-5 polymorphism 【摘 要】Polymorphism anal. is of fundamental pharmaceutical importance for correct development of a drug, as it provides valuable knowledge of its biopharmaceutical and technol. aspects. Indeed, different polymorphs exhibit different phys. properties that can affect bioavailability. Polymorphism screening has been developed in the authors' lab., based on crystn. parameter variations for a given drug in soln. Sodium valproate is an anti-epileptic drug commercialized under the name Depakine. Five polymorphic forms were obtained by the screening and characterized by differential scanning calorimetry, X-ray powder diffractometry, thermogravimetry and IR spectroscopy. The relationships between these forms were examd.   [更多]

需符合《新藥品管理法》、《新藥品注冊(cè)管理辦法》等相關(guān)新法律法規(guī)。完全符合者共計(jì)200rmb酬金，50rmb為部分酬金。 舉例： 質(zhì)量管理制度中供貨單位審核管理制度? ? ? ? 改 根據(jù)新藥品管理法要求修訂內(nèi)容，收集的資料內(nèi)容需調(diào)整，取消收集GMP、GSP證書等。 舉例2： 質(zhì)量管理制度?中不合格藥品管理制度? ? ? ? ?改 根據(jù)新藥品管理法要求修訂內(nèi)容，調(diào)整假劣藥定義，增加無公害處理的內(nèi)容等?。 舉例3：。。。。。。。。   [更多]

求購Poria《EP10.2》的藥典標(biāo)準(zhǔn)一份   [更多]