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1.00892 SAFC

Sucrose

Emprove® Essential, Ph. Eur., BP, JP, NF

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

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Binders & Fillers, Biomolecule Liquid Dosage Forms, Biopharmaceutical Process Development and Manufacturing, Excipients,
Agency/Method   BP
  JP
  NF
  Ph. Eur.
Quality Level   500
product line   Emprove® Essential
form   liquid
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
InChI key   CZMRCDWAGMRECN-UGDNZRGBSA-N
storage conditions   Store at +5°C to +30°C.

Description

General description

Chemicals play an important role in the stabilization of a biologic drug during its manufacturing and formulation process – for instance, by preventing aggregation. We offer a wide range of high-quality stabilizers, buffers and salts to successfully purify and formulate your biomolecules. Specifically developed for high-risk applications, they are low in bioburden and endotoxins.
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.

Application

Sucrose is widely used as a stabilizer / bulking agent for the formulation of biomolecules.A grade with low nanoparticle impurities is also available (Art.No. 103789).
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: <2
Microbiological purity(Total aerobic microbial count (TAMC)): ≤ 500 CFU/g
Microbiological purity(Total yeast and mould count (TYMC)): ≤ 100 CFU/g
Bile tolerant Gram negative Bacteria(absent in 1 g): passes test
Escherichia coli (absent in 1 g): passes test
Pseudomonas aeruginosa (absent in 1 g): passes test
Staphylococcus aureus (absent in 1 g): passes test
Candida albicans (absent in 1 g): passes test
Salmonella ssp (absent in 10 g): passes test
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

Safety Information for this product is unavailable at this time.

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