產(chǎn)品風(fēng)險(xiǎn)分析報(bào)告 產(chǎn)品技術(shù)要求 產(chǎn)品檢驗(yàn)報(bào)告 臨床評(píng)價(jià)資料 產(chǎn)品說(shuō)明書(shū)及標(biāo)簽樣稿 與產(chǎn)品研制、生產(chǎn)有關(guān)的質(zhì)量管理體系文件 生產(chǎn)制造信息 符合性聲明等等   [更多]

醋酸加尼瑞克標(biāo)準(zhǔn)JX20050220中提到的雜質(zhì)Org42887，Org14737，Org14741，Org14730，RRT0.92，需要明確其結(jié)構(gòu)。要求提供這5個(gè)雜質(zhì)明確的結(jié)構(gòu)或序列，并且需要提供來(lái)源信息。   [更多]

左乙拉西坦口服溶液注冊(cè)的質(zhì)量標(biāo)準(zhǔn)   [更多]

急需液體敷料一類(lèi)醫(yī)療器械備案全套申請(qǐng)資料 產(chǎn)品風(fēng)險(xiǎn)分析報(bào)告 產(chǎn)品技術(shù)要求 產(chǎn)品檢驗(yàn)報(bào)告 臨床評(píng)價(jià)資料 產(chǎn)品說(shuō)明書(shū)及標(biāo)簽樣稿 生產(chǎn)制造信息 符合性聲明   [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(yè) 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]

全套MAH質(zhì)量管理體系文件及目錄 價(jià)格可以協(xié)商   [更多]

1，涉及委托生產(chǎn)及委托研發(fā)類(lèi)的，MAH整套的管理制度，報(bào)告，記錄 2，中文word文檔   [更多]

重組蛋白發(fā)酵、純化、檢測(cè)全套SOP資料   [更多]

需要冰片市場(chǎng)調(diào)查報(bào)告 包括市場(chǎng)份額、產(chǎn)量、生產(chǎn)、提純技術(shù)、藥用占比等等多維度數(shù)據(jù)   [更多]

成分或者是微酸性電解水/氧化還原電位水 要求主要成分是次氯酸的 一類(lèi)器械液體敷料備案資料包括產(chǎn)品與生產(chǎn)整個(gè)環(huán)節(jié)。 產(chǎn)品風(fēng)險(xiǎn)分析報(bào)告 產(chǎn)品技術(shù)要求 產(chǎn)品檢驗(yàn)報(bào)告 臨床評(píng)價(jià)資料 產(chǎn)品說(shuō)明書(shū)及標(biāo)簽樣稿 與產(chǎn)品研制、生產(chǎn)有關(guān)的質(zhì)量管理體系文件 生產(chǎn)制造信息 符合性聲明等等   [更多]