Msynth® plus
Product + Qualification Dossier + Change Control
品牌故事 :
Msynth® plus,一個陌生的名字,單由字面上去做解析不難理解,這是Merck Millipore 針對有機合成市場的需求所設立的產品線,plus 的由來則是為了因應要求日益嚴格的法規Merck Millipore在產品背後所做的努力。
故事背後 :
莫忘曾經造成莫大恐慌與傷害的三聚氰胺(Melamine)牛奶事件[2008]與劣質肝素(Heparin)醜聞[2007],這類食品與醫藥商品原物料的追溯資訊逐漸受到消費者與主管機關的重視,進而要求生產廠商必須對其生產的原物料來源進行管控與稽核,其目的不外乎為了保障消費者安全與廠商賴以生存的商譽。類似的要求來自各個產業,化妝品、醫藥、電子業為其中舉足輕重的代表。
誠如大家對有機合成的了解,相同的產品可藉由不同的合成路徑取得,縱使最終產物的純度一致,但其中的不純物種類與含量卻是截然不同,而魔鬼就經常是隱藏在這細微的差異中。也因此,有機合成中的起始原料、添加劑、溶劑等物料都必須了解其追溯源,避免上述事件的再發生。而這一切的一切都必須仰賴供應商與使用者的緊密聯繫與定時稽核,Change Control 的機制建立在這流程中就扮演著舉足輕重的腳色。
Msynth® plus 針對醫藥、電子甚至化妝品產業對於原物料追溯源的重視與未來法規可能的要求做出篩選,經過自我審核與供應商稽核機制的完成,針對所選定的每一項產品提供合格的文件[Qualification Dossier],內容將稽核、規範所需的相關資訊集合成一份正式文件,提供給使用者做為參考,Merck Millipore 相信,藉由Msynth® plus產品線的協助,客戶有機合成的流程將得到更透明、更安全的保障。
以下,我們針對Msynth® plus 所能提供的便利一一說明,
關於Msynth® plus Qualification Dossier的內容涵蓋如下,
l Specification
l Safety Data Sheet
l Testing procedure
l Continent of origin
l Principle of synthesis
l BSE/TSE certificate
l RoHS certificate
l Information regarding residual solvents
l Information regarding residues of metal catalysts/metal reagents
關於Msynth® plus Change Control的評估流程將不侷限於Merck Millipore本身,其範圍也擴及我們的原物料供應商,其背後意義是,原物料的追溯源將被確立,因此,一旦Merck Millipore 接受客戶關於Change Control 簽署的要求,客戶所得到的保障將不僅只限於與Merck Millipore的之間的協議,Merck Millipore 同時也會取得與其原物料供應商之間的Change Control協議,如此,原物料的追溯鏈方才確立。Msynth® plus Change Control對於已協議客戶的承諾,在下列情況有變更時,客戶將接受到通知,
l Specification
l Plant or manufacturing site
l Synthesis route
l Status BSE/TSE
l Residual solvents
l Residues of metal catalysts/metal reagents
瞭解了上述資訊,您是否想進一步認識Msynth® plus涵蓋了哪些重要的產品呢?
Msynth® plus 現階段包含了有機與無機相關化學品,其中有31種Building blocks、3種Catalysts、5種Polymerization試劑、28種Reagents、2種合成用的溶劑以及9種胜肽合成試劑且持續增加中,我們也承諾在未來我們將不斷擴增Msynth® plus產品線的廣度,讓有機合成的流程更加透明,您無須再操煩文件的收集與稽核的要求,Msynth® plus都可滿足您的需求。
Msynth®plus - from grams to tons, we deliver 包裝彈性,從研發[小包裝],試製[中包裝]到量產[客製化包裝],一應具全 完整的文件[Qualification Dossier] ,無須傷神文件的蒐集 Change Control - 客戶與Merck Millipore 共同協議簽署下,量產原物料資料透明,更有保障 | |||
產品編號 | 產品名稱 | CAS No. | 產品類別 |
845001 | Acetaldehyde Msynth®plus | 75-07-0 | Building Blocks |
845087 | Acetaldehyde dimethyl acetal Msynth®plus | 534-15-6 | Building Blocks |
845019 | Aluminium chloride (anhydrous, powder, ground) Msynth®plus | 7446-70-0 | Reagents |
845129 | p-Aminophenol Msynth®plus | 123-30-8 | Building Blocks |
845049 | Aminopropanol (mixture of isomers) Msynth®plus | 78-96-6 | Building Blocks |
845003 | p-Anisidine Msynth®plus | 104-94-9 | Building Blocks |
845091 | Benzamidine hydrochloride hydrate Msynth®plus | 206752-36-5 | Building Blocks |
845004 | Benzenesulfonic acid Msynth®plus | 98-11-3 | Building Blocks |
845005 | Benzenesulfonyl chloride Msynth®plus | 98-09-9 | Reagents |
845024 | Benzyl chloride Msynth®plus | 100-44-7 | Reagents |
845065 | Benzyltriethylammonium chloride Msynth®plus | 56-37-1 | Catalyst |
845154 | 1,3-Butandiol Msynth®plus | 107-88-0 | Polymerisation |
845021 | Butylamine Msynth®plus | 109-73-9 | Building Blocks |
845134 | 4-Carboxybutyltriphenylphosphonium bromide Msynth®plus | 17814-85-6 | Reagents |
845148 | 2-Chloroacetamide Msynth®plus | 79-07-2 | Building Blocks |
845141 | Chloroacetyl chloride Msynth®plus | 79-04-9 | Reagents |
845095 | 2-Chlorobenzaldehyde Msynth®plus | 89-98-5 | Building Blocks |
845027 | N-Chlorosuccinimide Msynth®plus | 128-09-6 | Reagents |
845127 | Chlorosulfonic acid Msynth®plus | 7790-94-5 | Reagents |
845142 | Dehydracetic acid sodium salt Msynth®plus | 4418-26-2 | Building Blocks |
845035 | Dibutyltin oxide Msynth®plus | 818-08-6 | Peptide Synthesis |
845195 | 1,1'-Carbonyldiimidazole Msynth®plus | 530-62-1 | Peptide Synthesis |
845033 | 1,1-Dichloroethylene (stabilised with hydrochinone monomethyl ether) Msynth®plus | 75-35-4 | Polymerisation |
845149 | 2,5-Dichlorophenol Msynth®plus | 583-78-8 | Building Blocks |
845159 | Diethanolamine Msynth®plus | 111-42-2 | Reagents |
845028 | Diethylamine Msynth®plus | 109-89-7 | Building Blocks |
845009 | Diethyl succinate Msynth®plus | 123-25-1 | Building Blocks |
845051 | Diethyl oxalate Msynth®plus | 95-92-1 | Reagents |
845036 | Diisopropyl amine Msynth®plus | 108-18-9 | Building Blocks |
845123 | Diisopropyl ether (stabilised with BHT) Msynth®plus | 108-20-3 | Solvents for synthesis |
845140 | 3,4-Dimethoxybenzoic acid Msynth®plus | 93-07-2 | Building Blocks |
845029 | Dimethylammonium chloride Msynth®plus | 506-59-2 | Building Blocks |
845116 | 3,4-Dimethylanisole Msynth®plus | 4685-47-6 | Building Blocks |
845034 | 1,2-Dimethylimidazole Msynth®plus | 1739-84-0 | Building Blocks |
845097 | N-Dodecane Msynth®plus | 112-40-3 | Building Blocks |
845104 | Ethanesulfonyl chloride Msynth®plus | 594-44-5 | Building Blocks |
845014 | Ethanolamine Msynth®plus | 141-43-5 | Peptide Synthesis |
845088 | Ethylamine (70% solution in water) Msynth®plus | Reagents | |
845018 | Ethylenediamine Msynth®plus | 107-15-3 | Peptide Synthesis |
845017 | N-Ethyldiisopropylamine Msynth®plus | 7087-68-5 | Reagents |
845073 | Glycolic acid (70% solution in water) Msynth®plus | Reagents | |
845068 | Hydroxylamine ( 50% solution in water) Msynth®plus | Reagents | |
845040 | 2-Imidazolidinone hemihydrate Msynth®plus | 121325-67-5 | Building Blocks |
845045 | Iodomethane (stabilised with silver) Msynth®plus | 74-88-4 | Building Blocks |
845124 | Iron(III) chloride (anhydrous) Msynth®plus | 7705-08-0 | Reagents |
845053 | Isopropylamine Msynth®plus | 75-31-0 | Peptide Synthesis |
845042 | Magnesium turnings acc. to Grignard Msynth®plus | 7439-95-4 | Reagents |
845002 | Maleic acid Msynth®plus | 110-16-7 | Peptide Synthesis |
845122 | Maleic anhydride Msynth®plus | 108-31-6 | Polymerisation |
845044 | Methanesulfonic acid Msynth®plus | 75-75-2 | Reagents |
845043 | Methanesulfonyl chloride Msynth®plus | 124-63-0 | Peptide Synthesis |
845103 | 2-Methyltetrahydrofuran (stabilised with 2,6-di-tert-butyl-4-methylphenol) Msynth®plus | 96-47-9 | Solvents for synthesis |
845086 | 1-Naphthol Msynth®plus | 90-15-3 | Peptide Synthesis |
845193 | Nickel(II) chloride (anhydrous) Msynth®plus | 7718-54-9 | Reagents |
845114 | 3-Nitro-benzeneboronic acid Msynth®plus | 13331-27-6 | Building Blocks |
845071 | 1,2-Phenylendiamine Msynth®plus | 95-54-5 | Building Blocks |
845113 | Phosphoryl chloride Msynth®plus | 10025-87-3 | Reagents |
845120 | Piperazine (anhydrous) Msynth®plus | 110-85-0 | Building Blocks |
845111 | Piperidine Msynth®plus | 110-89-4 | Building Blocks |
845055 | Pyrrole Msynth®plus | 109-97-7 | Building Blocks |
845008 | Selenium dioxide (sublimed) Msynth®plus | 7446-08-4 | Reagents |
845048 | Sodium borohydride (fine granular) Msynth®plus | 16940-66-2 | Reagents |
845066 | Sodium bromate Msynth®plus | 7789-38-0 | Reagents |
845144 | Sodium butyrate Msynth®plus | 156-54-7 | Building Blocks |
845101 | Sodium ethylate Msynth®plus | 141-52-6 | Reagents |
845119 | Sodium hydrogen sulfite (39% solution in water) Msynth®plus | Reagents | |
845143 | Sodium tungstate dihydrate Msynth®plus | 10213-10-2 | Catalyst |
845010 | Succinic anhydride Msynth®plus | 108-30-5 | Peptide Synthesis |
845151 | Tetramethylammonium hydroxide (25% solution in water) Msynth®plus | Reagents | |
845083 | Tetra-n-butylammonium hydrogensulfate Msynth®plus | 32503-27-8 | Catalyst |
845136 | 4-Toluenesulfonyl chloride Msynth®plus | 98-59-9 | Reagents |
845061 | Triethylamine Msynth®plus | 121-44-8 | Polymerisation |
845145 | Triethylsilane Msynth®plus | 617-86-7 | Reagents |
845060 | Trifluoroacetic anhydride Msynth®plus | 407-25-0 | Reagents |
845150 | Triisopropyl borate Msynth®plus | 5419-55-6 | Reagents |
845064 | Trioctylamine Msynth®plus | 1116-76-3 | Polymerisation |
845130 | Tropolone Msynth®plus | 533-75-5 | Building Blocks |
845139 | Undecanoyl chloride Msynth®plus | 17746-05-3 | Building Blocks |