MERCK

MERCK

2015年8月17日 星期一

Msynth® plus 有機合成新標竿

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
845001Acetaldehyde Msynth®plus75-07-0Building Blocks
845087Acetaldehyde dimethyl acetal Msynth®plus534-15-6Building Blocks
845019Aluminium chloride (anhydrous, powder, ground) Msynth®plus7446-70-0Reagents
845129p-Aminophenol Msynth®plus123-30-8Building Blocks
845049Aminopropanol (mixture of isomers) Msynth®plus78-96-6Building Blocks
845003p-Anisidine Msynth®plus104-94-9Building Blocks
845091Benzamidine hydrochloride hydrate Msynth®plus206752-36-5Building Blocks
845004Benzenesulfonic acid Msynth®plus98-11-3Building Blocks
845005Benzenesulfonyl chloride Msynth®plus98-09-9Reagents
845024Benzyl chloride Msynth®plus100-44-7Reagents
845065Benzyltriethylammonium chloride Msynth®plus56-37-1Catalyst
8451541,3-Butandiol Msynth®plus107-88-0Polymerisation
845021Butylamine Msynth®plus109-73-9Building Blocks
8451344-Carboxybutyltriphenylphosphonium bromide Msynth®plus17814-85-6Reagents
8451482-Chloroacetamide Msynth®plus79-07-2Building Blocks
845141Chloroacetyl chloride Msynth®plus79-04-9Reagents
8450952-Chlorobenzaldehyde Msynth®plus89-98-5Building Blocks
845027N-Chlorosuccinimide Msynth®plus128-09-6Reagents
845127Chlorosulfonic acid Msynth®plus7790-94-5Reagents
845142Dehydracetic acid sodium salt Msynth®plus4418-26-2Building Blocks
845035Dibutyltin oxide Msynth®plus818-08-6Peptide Synthesis
8451951,1'-Carbonyldiimidazole Msynth®plus530-62-1Peptide Synthesis
8450331,1-Dichloroethylene (stabilised with hydrochinone monomethyl ether) Msynth®plus75-35-4Polymerisation
8451492,5-Dichlorophenol Msynth®plus583-78-8Building Blocks
845159Diethanolamine Msynth®plus111-42-2Reagents
845028Diethylamine Msynth®plus109-89-7Building Blocks
845009Diethyl succinate Msynth®plus123-25-1Building Blocks
845051Diethyl oxalate Msynth®plus95-92-1Reagents
845036Diisopropyl amine Msynth®plus108-18-9Building Blocks
845123Diisopropyl ether (stabilised with BHT) Msynth®plus108-20-3Solvents for synthesis
8451403,4-Dimethoxybenzoic acid Msynth®plus93-07-2Building Blocks
845029Dimethylammonium chloride Msynth®plus506-59-2Building Blocks
8451163,4-Dimethylanisole Msynth®plus4685-47-6Building Blocks
8450341,2-Dimethylimidazole Msynth®plus1739-84-0Building Blocks
845097N-Dodecane Msynth®plus112-40-3Building Blocks
845104Ethanesulfonyl chloride Msynth®plus594-44-5Building Blocks
845014Ethanolamine Msynth®plus141-43-5Peptide Synthesis
845088Ethylamine (70% solution in water) Msynth®plus Reagents
845018Ethylenediamine Msynth®plus107-15-3Peptide Synthesis
845017N-Ethyldiisopropylamine Msynth®plus7087-68-5Reagents
845073Glycolic acid (70% solution in water) Msynth®plus Reagents
845068Hydroxylamine ( 50% solution in water) Msynth®plus Reagents
8450402-Imidazolidinone hemihydrate Msynth®plus121325-67-5Building Blocks
845045Iodomethane (stabilised with silver) Msynth®plus74-88-4Building Blocks
845124Iron(III) chloride (anhydrous) Msynth®plus7705-08-0Reagents
845053Isopropylamine Msynth®plus75-31-0Peptide Synthesis
845042Magnesium turnings acc. to Grignard Msynth®plus7439-95-4Reagents
845002Maleic acid Msynth®plus110-16-7Peptide Synthesis
845122Maleic anhydride Msynth®plus108-31-6Polymerisation
845044Methanesulfonic acid Msynth®plus75-75-2Reagents
845043Methanesulfonyl chloride Msynth®plus124-63-0Peptide Synthesis
8451032-Methyltetrahydrofuran (stabilised with 2,6-di-tert-butyl-4-methylphenol) Msynth®plus96-47-9Solvents for synthesis
8450861-Naphthol Msynth®plus90-15-3Peptide Synthesis
845193Nickel(II) chloride (anhydrous) Msynth®plus7718-54-9Reagents
8451143-Nitro-benzeneboronic acid Msynth®plus13331-27-6Building Blocks
8450711,2-Phenylendiamine Msynth®plus95-54-5Building Blocks
845113Phosphoryl chloride Msynth®plus10025-87-3Reagents
845120Piperazine (anhydrous) Msynth®plus110-85-0Building Blocks
845111Piperidine Msynth®plus110-89-4Building Blocks
845055Pyrrole Msynth®plus109-97-7Building Blocks
845008Selenium dioxide (sublimed) Msynth®plus7446-08-4Reagents
845048Sodium borohydride (fine granular) Msynth®plus16940-66-2Reagents
845066Sodium bromate Msynth®plus7789-38-0Reagents
845144Sodium butyrate Msynth®plus156-54-7Building Blocks
845101Sodium ethylate Msynth®plus141-52-6Reagents
845119Sodium hydrogen sulfite (39% solution in water) Msynth®plus Reagents
845143Sodium tungstate dihydrate Msynth®plus10213-10-2Catalyst
845010Succinic anhydride Msynth®plus108-30-5Peptide Synthesis
845151Tetramethylammonium hydroxide (25% solution in water) Msynth®plus Reagents
845083Tetra-n-butylammonium hydrogensulfate Msynth®plus32503-27-8Catalyst
8451364-Toluenesulfonyl chloride Msynth®plus98-59-9Reagents
845061Triethylamine Msynth®plus121-44-8Polymerisation
845145Triethylsilane Msynth®plus617-86-7Reagents
845060Trifluoroacetic anhydride Msynth®plus407-25-0Reagents
845150Triisopropyl borate Msynth®plus5419-55-6Reagents
845064Trioctylamine Msynth®plus1116-76-3Polymerisation
845130Tropolone Msynth®plus533-75-5Building Blocks
845139Undecanoyl chloride Msynth®plus17746-05-3Building Blocks

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