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Merck

1.07654

SAFC

Sucrose (saccharose)

EMPROVE® Bio, Ph. Eur., BP, NF, JP

의약품 제조

동의어(들):

Sucrose, Saccharose, α-D-Glc-(1→2)-β-D-Fru, α-D-Glucopyranosyl β-D-fructofuranoside, β-D-Fructofuranosyl-α-D-glucopyranoside, D(+)-Saccharose, Sugar

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About This Item

실험식(Hill 표기법):
C12H22O11
CAS Number:
Molecular Weight:
342.30
Beilstein:
90825
MDL number:
UNSPSC 코드:
12352201
EC 인덱스 번호:
200-334-9

Agency

BP
JP
NF
Ph. Eur.

Quality Level

제품 라인

EMPROVE® Bio

형태

solid

효능

29700 mg/kg LD50, oral (Rat)

pH

7 (20 °C, 100 g/L in H2O)

mp

185-187 °C (lit.)

벌크 밀도

800‑950 kg/m3

저장 온도

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

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일반 설명

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.

분석 메모

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

법적 정보

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

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point (°F)

Not applicable

Flash Point (°C)

Not applicable


시험 성적서(COA)

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