1.07653 SAFC



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

  • CAS Number 57-50-1

  • Empirical Formula (Hill Notation) C12H22O11

  • Molecular Weight 342.30

  •  Beilstein/REAXYS Number 90825

  •  MDL number MFCD00006626

  •  EC Index Number 200-334-9



Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Binders & Fillers, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms,
Agency/Method   BP
  Ph. Eur.
Quality Level   500
product line   Emprove® Essential
form   powder or granules
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
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
storage conditions   Store at +5°C to +30°C.


General description

Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge in formulation. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.
As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.


Sucrose has a wide range of different pharmaceutical applications. In solid dosage forms, it is commonly used as a dry binder or filler in formulations where a sweet taste is a welcome side effect, e.g. in lozenges or chewables.
The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

Analysis Note

Identity: passes test
Appearance of solution (50%; water): passes test
Color number: ≤ 45
Spec. rotation (α 20/D; 26%; water): 66.3 - 67.0 °
Electrical conductivity: ≤ 35 µS/cm
Sulfite (as SO₂): ≤ 10 ppm
Dextrins: passes test
Reducing sugars: passes test
Residual solvents (ICH Q3C): excluded by production process
Loss on Drying (105 °C): ≤ 0.1%
Endotoxins: <250
Elemental 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

Safety & Documentation

Safety Information

WGK Germany 
Flash Point(F) 
Not applicable
Flash Point(C) 
Not applicable

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