Parteck® SI 400 LEX (Sorbitol), EMPROVE® exp Ph. Eur., BP, NF, JP suitable for use as excipient, SAFC®

Supplier: EMD MILLIPORE – PCS CA EXCEP

Certificates

Supplier: EMD MILLIPORE – PCS CA EXCEP

Certificates

About this item

Synonyms: (2R,3R,4R,5S)-Hexane-1,2,3,4,5,6-hexaol,(Sorbitol),D(-)-Glucitol

CAS Number:50-70-4

:98201-93-5

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

Merck Index:12,08873

:Length:

:Width:

:Height:

:Ø

:Thickness:

:Boiling Pt:

:Boiling Pt: 295 °C (1013 hPa)

:Melting Pt:

:Melting Pt: 94…98 °C

:Flash Pt:

:Flash Pt: >100 °C

:M.W. 182.17 g/mol

:Parteck® SI 400 LEX (Sorbitol)

EINECS:200-061-5

:>100 °C

Storage Temperature:Ambient

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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