1.07654
スクロース
EMPROVE® Bio, Ph. Eur., BP, NF, JP
別名:
α-D-Glc-(1→2)-β-D-Fru, α-D-グルコピラノシルβ-D-フルクトフラノシド, β-D-フルクトフラノシル-α-D-グルコピラノシド, D(+)-サッカロース, 砂糖
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この商品について
実験式（ヒル表記法）:
C12H22O11
CAS番号:
分子量:
342.30
EC Index Number:
200-334-9
UNSPSC Code:
12352201
Beilstein/REAXYS Number:
90825
MDL number:
Quality Level
agency
BP, JP, NF, Ph. Eur.
product line
EMPROVE® Bio
form
solid
potency
29700 mg/kg LD50, oral (Rat)
pH
7 (20 °C, 100 g/L in H2O)
mp
185-187 °C (lit.)
bulk density
800‑950 kg/m3
storage temp.
no temp limit
SMILES string
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
General description
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.
Analysis Note
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
Legal Information
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany
保管分類
11 - Combustible Solids
wgk
WGK 1
flash_point_f
Not applicable
flash_point_c
Not applicable
試験成績書（COA）
製品のロット番号・バッチ番号を入力して、試験成績書（COA） を検索できます。ロット番号・バッチ番号は、製品ラベルに「Lot」または「Batch」に続いて記載されています。
グローバルトレードアイテム番号
| カタログ番号 | GTIN |
|---|---|
| 1.07654.1000 | 04022536093437 |
| 1.07654.9029 | 04027269246907 |
| 1.07654.5000 | 04022536093451 |