MilliporeSigma
All Photos(3)

1.07654

SAFC

Sucrose (saccharose)

EMPROVE® Bio, Ph. Eur., BP, NF, JP

Synonym(s):
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
Empirical Formula (Hill Notation):
C12H22O11
CAS Number:
Molecular Weight:
342.30
Beilstein:
90825
MDL number:
EC Index Number:
200-334-9

Agency

BP
JP
NF
Ph. Eur.

Quality Level

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

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1.076531.037891.07687
Sucrose (saccharose) EMPROVE® Bio, Ph. Eur., BP, NF, JP

SAFC

1.07654

Sucrose (saccharose)

Sucrose EMPROVE® ESSENTIAL, Ph. Eur., BP, ChP, JP, NF

SAFC

1.07653

Sucrose

Sucrose EMPROVE® EXPERT, Ph. Eur., ChP, JP, NF

SAFC

1.03789

Sucrose

Sucrose for biochem. Reag. Ph Eur

Millipore

1.07687

Sucrose

product line

EMPROVE® Bio

product line

EMPROVE® ESSENTIAL

product line

EMPROVE® EXPERT

product line

-

form

solid

form

solid

form

solid

form

solid

mp

185-187 °C (lit.)

mp

185-187 °C (lit.)

mp

185-187 °C (lit.)

mp

185-187 °C (lit.)

storage temp.

no temp limit

storage temp.

2-30°C

storage temp.

2-30°C

storage temp.

15-25°C

Quality Level

500

Quality Level

500

Quality Level

500

Quality Level

100

agency

BP

agency

BP, ChP, JP, NF, Ph. Eur.

agency

ChP, JP, NF, Ph. Eur.

agency

reag. Ph. Eur.

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.

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

Legal Information

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


What is the Emprove® Program?

The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials. Four document types are included with an Emprove® Program subscription:

Material Qualification Dossier

Free of charge - Sign in to download

Quality Management Dossier

Available by subscription or for a fee

Operational Excellence Dossier

Available by subscription or for a fee

Learn more about the benefits an Emprove® Program subscription can provide
Why are these documents unavailable?
Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.

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