Parteck® SI 400 LEX (Sorbitol), EMPROVE® EXPERT NF, JP, Ph. Eur., BP excipient_suitable, SAFC®
Lieferant: Merck
Synonyme:
D(-)-Glucit, (2R,3R,4R,5S)-(-)-1,2,3,4,5,6-Hexanhexol, D(-)-Sorbitol, D(-)-Glucitol
1.11597.9028
1.11597.2500
1.11597.9012
1.11597.9028EA
1210
EUR
1.11597.9028
1.11597.2500
1.11597.9012
Parteck® SI 400 LEX (Sorbitol), EMPROVE® EXPERT NF, JP, Ph. Eur., BP excipient_suitable, SAFC®
D(-)-Sorbit
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 (#).
Standards: corresponds to Ph. Eur., BP, NF, JP
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Formel:
HOH₂C(CH(OH))₄CH₂OH Molecular Weight: 182.17 g/mol Siedepunkt: 295 Schmelzpunkt: 94…98 °C Dichte: 1.524 g/cm³ (20 °C) Flammpunkt: >100 °C Lagertemperatur: Raumtemperatur |
MDL:
MFCD00004708 CAS-Nummer: 50-70-4 EINECS: 200-061-5 Merck Index: 13,08797 |
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Spezifikation Testergebnisse
| 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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