Sorbitol P20-40
Miasto: LV, Marupe
Please avoid sudden changes in temperature and humidity, as they may affect the condition of derivative ingredients and tablets.
The shelf life begins from the date of manufacture at the factory.
Taking into account logistical and transportation stages, the remaining shelf life of the product is always shorter than the full shelf life.
We ship products to our customers with a remaining shelf life of no less than 70%.
Physical & Chemical Characteristics
Analysis Item | Specification | Result |
Appearance | White powder | Conforms |
Solubility | Very soluble in water; slightly soluble in ethanol | Conforms |
Melting range (°C) | 89.0–102.0 | Conforms |
Appearance of solution | Clear | Conforms |
Conductivity (μS/cm) | ≤20.0 | <20.0 |
pH (10% soln) | 3.5–7.0 | 6.2 |
Granulation (mesh) | 20–40 | 20–40 |
EU number | E420(I) | E420(I) |
Purity
Analysis Item | Specification | Result |
Assay (min, %) | 98.0 | 98.6 |
Moisture (max, %) | 1.5 | 0.28 |
D-Mannitol (max, %) | 1.0 | 0.65 |
Reducing sugars (max, %) | 0.3 | 0.03 |
Total sugar (max, %) | 0.5 | 0.24 |
Residue on ignition (max, %) | 0.1 | 0.03 |
SO₂ (max, mg/kg) | 10.0 | <10.0 |
Sorbitol monobenzylidene derivative | According to Regulation 231/2012/EC | Conforms |
Inorganic Ions
Analysis Item | Specification | Result |
Chlorides (max, mg/kg) | 50.0 | <50.0 |
Sulphates (max, mg/kg) | 50.0 | <50.0 |
Heavy Metals
Analysis Item | Specification | Result |
Lead (Pb) (max, mg/kg) | 1.0 | <1.0 |
Nickel (Ni) (max, mg/kg) | 1.0 | <1.0 |
Arsenic (As) (max, mg/kg) | 1.0 | <1.0 |
Cadmium (Cd) (max, mg/kg) | 0.5 | <0.5 |
Mercury (Hg) (max, mg/kg) | 1.0 | <1.0 |
Microbiological Tests
Analysis Item | Specification | Result |
Total Plate Count (max, CFU/g) | 1000 | <1000 |
Yeast (max, CFU/g) | 100 | <10 |
Moulds (max, CFU/g) | 100 | <10 |
Salmonella (in 25 g) | Absent | Absent |
Staphylococcus aureus (in 25 g) | Absent | Absent |
E. coli (in 1 g) | Absent | Absent |
Coliforms (in 1 g) | Absent | Absent |