Parteck® M 200 (Mannitol) 98.0-101.0% (by HPLC on dried basis), EMPROVE® ESSENTIAL BP, JP, Ph. Eur., USP, E421, SAFC®
CA1.00419.9025
:
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- Pack type:Fibre carton
- Size:25 kg
- Cat. no.:CA1.00419.9025
- Supplier No.:1.00419.9025
- Assay (HPLC, calc. on dried substance):98.0 - 101.0 %
- Identity (NIR):passes test
- Appearance of solution (10 %; water):passes test
- pH-value (10 %; water):4.5 - 7.5
- Melting point:165 - 169
- Conductivity (25°C) (20 %; water):≤ 20
- Heavy metals (as Pb):≤ 5 ppm
- Ni (Nickel) (#):≤ 1 ppm
- Pb (Lead):≤ 0.5 ppm
- Related substances (HPLC) (Sorbitol (Impurity A)):≤ 2.0 %
- Related substances (HPLC) (Sum of Maltitol and Isomalt (Impurities B and C)):≤ 2.0
- Related substances (HPLC) (Major unspecified impurity):≤ 0.10 %
- Related substances (HPLC) (Sum of all impurities):≤ 2.0 %
- Reducing sugars (as glucose):≤ 0.05
- Reducing sugars after hydrolysis/total sugar (as glucose):≤ 1
- Sulfated ash:≤ 0.1
- Water:≤ 0.5 %
- Loss on Drying (105 °C):≤ 0.30 %
- Particle size ( 53 µm):≤ 15 %
- Particle size ( 500 µm):≤ 15 %
- Residual solvents (ICH Q3C):excluded by manufacturing process
- Microbiological test:passes test
- Colony count (aerobic bacteria (TAMC)):≤ 10³
- Colony count (Yeasts and moulds (TYMC)):≤ 10²
- Salmonella spp.:in 10g Substance not detectable
- E.coli:in 1g Substance not detectable
- Staphylococcus aureus:in 1g Substance not detectable
- Pseudomonas aeruginosa:in 1g Substance not detectable
- Candida albicans:In 1g Substance not detectable
:
:182.17 g/mol
:13,05769
:290…295 °C (4 hPa)
:290 - 295 °C (4 hPa)
:164…169 °C
:164 - 169 °C
:1,49 g/cm³ (20 °C)
:Ambient
:200-711-8
:69-65-8
:HOH₂C(CH(OH))₄CH₂OH
:MFCD00064287