1.07654

Sacarose

EMPROVE^® Bio, Ph. Eur., BP, NF, JP

• Sinônimo(s): α α-D-Glc-(1→2)-β-D-Fru, α α-D-glicopiranosil β-D-frutofuranosídeo, ββ-D-frutofuranosil-α-D-glicopiranosídeo, D(+)-sacarose, Açúcar
• Fórmula empírica (Notação de Hill): C₁₂H₂₂O₁₁
• Número CAS: 57-50-1
• Peso molecular: 342.30
• Beilstein: 90825
• Número MDL: MFCD00006626
• Código UNSPSC: 12352201
• Número do índice EC: 200-334-9

Propriedades

• Agency: BP; JP; NF; Ph. Eur.
• Nível de qualidade: 500
• linha de produto: EMPROVE^® Bio
• forma: solid
• potência: 29700 mg/kg LD₅₀, oral (Rat)
• pH: 7 (20 °C, 100 g/L in H₂O)
• pf: 185-187 °C (lit.)
• densidade volumétrica: 800‑950 kg/m³
• temperatura de armazenamento: no temp limit
• cadeia de caracteres SMILES: 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
• chave InChI: CZMRCDWAGMRECN-UGDNZRGBSA-N

Descrição

Descrição geral

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.

Nota de análise

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

Informações legais

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

Informações de segurança

• Código de classe de armazenamento: 11 - Combustible Solids
• Classe de risco de água (WGK): WGK 1
• Ponto de fulgor (°F): Not applicable
• Ponto de fulgor (°C): Not applicable