推荐产品
Agency
BP
JP
NF
Ph. Eur.
质量水平
产品线
EMPROVE® Bio
表单
solid
效能
29700 mg/kg LD50, oral (Rat)
pH值（酸碱度）
7 (20 °C, 100 g/L in H2O)
mp
185-187 °C (lit.)
堆积密度
800‑950 kg/m3
储存温度
no temp limit
SMILES字符串
OC[C@H]1O[C@H](O[C@]2(CO)O[C@H](CO)[C@@H](O)[C@@H]2O)[C@H](O)[C@@H](O)[C@@H]1O
InChI
1S/C12H22O11/c13-1-4-6(16)8(18)9(19)11(21-4)23-12(3-15)10(20)7(17)5(2-14)22-12/h4-11,13-20H,1-3H2/t4-,5-,6-,7-,8+,9-,10+,11-,12+/m1/s1
InChI key
CZMRCDWAGMRECN-UGDNZRGBSA-N
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一般描述
Our SAFC® portfolio of high-quality products for biopharmaceutical processing withstands strict quality control procedures and is produced according to MQ-500 requirements as defined by the M-Clarity program.
M-Clarity Program
As part of our EMPROVE® Program, our raw materials are offered with EMPROVE® Dossiers which provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.
Our comprehensive portfolio of upstream process chemicals not only provides biopharmaceutical manufacturers with high-quality raw materials for production of classical and novel therapies, but also helps them get to market faster and simplify regulatory challenges. Trust us to deliver supply chain transparency and reliable sourcing around the globe, streamlining your product qualification with best-in-class regulatory support and service.
M-Clarity Program
As part of our EMPROVE® Program, our raw materials are offered with EMPROVE® Dossiers which provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.
Our comprehensive portfolio of upstream process chemicals not only provides biopharmaceutical manufacturers with high-quality raw materials for production of classical and novel therapies, but also helps them get to market faster and simplify regulatory challenges. Trust us to deliver supply chain transparency and reliable sourcing around the globe, streamlining your product qualification with best-in-class regulatory support and service.
分析说明
Identity (IR-spectrum)passes testAppearance of solution (50%; water)passes testColor number≤ 45Spec. rotation (.a. 20/D;26% water)+66.3 - +67.0 °Conductivity (20 °C)≤ 35Sulfite (as SO₂)≤ 10 ppmDextrinspasses testReducing sugarspasses testResidual solvents (ICH Q3C) class 3 (Ethanol)≤ 0.5%Other residual solvents (ICH Q3C)excluded by manufacturing processLoss on Drying (105 °C)≤ 0.1Endotoxins<0.25Absorbance (260 nm; 50%; 1 cm; water)≤ 0.07Absorbance (280 nm; 50%; 1 cm; water)≤ 0.05DNases (Exo- and endonucleases)not detectedRNasesnot detectedProteasesnot detectedElemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities).
Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Corresponds to Ph.Eur.,BP,JP,NF
Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Corresponds to Ph.Eur.,BP,JP,NF
法律信息
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany
储存分类代码
11 - Combustible Solids
WGK
WGK 1
闪点(°F)
Not applicable
闪点(°C)
Not applicable
法规信息
监管及禁止进口产品
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