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Msynth® plus  

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31Building blocks3Catalysts5Polymerization試劑、28Reagents2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
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