Parteck® SI 400 LEX (Sorbitol), EMPROVE® EXPERT Ph. Eur., BP, NF, JP suitable for use as excipient, SAFC®
Supplier: EMD MILLIPORE – PCS CA EXCEP
Synonyms:
D-Sorbitol
, Sorbitol
, D(-)-Glucitol
, (Sorbitol)
, (2R,3R,4R,5S)-Hexane-1,2,3,4,5,6-hexaol
1.11597.1003
1.11597.9023
1.11597.1003
1.11597.9024
1.11597.9027
CA1.11597.1003EA
539.51
CAD
CA1.11597.1003
EM1.11597.9024
EM1.11597.9023
CA1.11597.9027
EM1.11597.1003
Parteck® SI 400 LEX (Sorbitol), EMPROVE® EXPERT Ph. Eur., BP, NF, JP suitable for use as excipient, SAFC®
D(-)-Sorbitol
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 (#).
Certifications: corresponds to Ph. Eur., BP, NF, JP
Formula:
HOH₂C(CH(OH))₄CH₂OH MW: 182.17 g/mol Boiling Pt: 295 °C (1013 hPa) Melting Pt: 94…98 °C Density: 1.524 g/cm³ (20 °C) Flash Pt: >100 °C |
MDL Number:
MFCD00004708 CAS Number: 50-70-4 Merck Index: 13,08797 |
Specification Test Results
Assay (HPLC, calc.on anhydrous substance) | 97.0 - 100.5 % |
Identity | passes test |
pH-value (10 %; water) | 3.5 - 7.0 |
Appearance of solution (25 %; water) | passes test |
Spec. rotation (α20/D, 10 %, borate complex, calc. on anhydrous substance) | +4.0 - +7.0 ° |
Conductivity (25°C) (20 %; water) | ≤ 20 |
Chloride (Cl) | ≤ 0.002 % |
Sulfate (SO₄) | ≤ 0.006 % |
Heavy metals (as Pb) | ≤ 5 ppm |
As (Arsenic) | ≤ 1.3 ppm |
Ni (Nickel) (#) | ≤ 1 ppm |
Pb (Lead) | ≤ 0.5 ppm |
Related substances (HPLC, EP) (Major impurity (Mannitol)) | ≤ 2.0 % |
Related substances (HPLC, EP) (Sum of all impurities) | ≤ 3.0 % |
Reducing sugars after hydrolysis/total sugar (as glucose) | ≤ 0.8 |
Reducing sugars (as glucose) | ≤ 0.11 % |
Sulfated ash | ≤ 0.02 % |
Loss on drying | ≤ 2.0 % |
Water | ≤ 1.5 % |
Residual solvents (ICH Q3C) | excluded by manufacturing process |
Microbiological test | passes test |
Colony count (aerobic bacteria (TAMC)) | ≤ 10² |
Colony count (Yeasts and moulds (TYMC)) | ≤ 10² |
Salmonella spp. | in 10g Substance not detectable |
E.coli | in 1g substance not detectable |
Pseudomonas aeruginosa | in 1g substance not detectable |
Staphylococcus aureus | in 1g substance not detectable |
Candida albicans | In 1g substance not detectable |
Endotoxins | ≤ 1 |
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