D-(-)-Mannitol 97.0-102.0%, powder, GenAR® USP for biotechnology, Macron Fine Chemicals™
: Avantor
:69-65-8
:
:HOH₂C(CH(OH))₄CH₂OH
:MFCD00064287
:182.17 g/mol
:13,05769
:290…295 °C (4 hPa)
:164…169 °C
:1.49 g/cm³ (20 °C)
:Management of Change (MOC) category = R
:Ambient
:200-711-8
- GMP Manufactured Product:—
- Meets U.S.P Requirements:—
- Meets B.P. Chemical Specifications:—
- Meets E.P. Chemical Specifications:—
- CAUTION: For Manufacturing, processing or repackaging:—
- Bulk Pharmaceutical Chemical:—
- USP - Assay (dried basis):97.0 - 102.0 %
- USP - Identification:Passes Test
- USP - Related Substances: Sorbitol:≤ 2.0 %
- USP - Related Substances: Sum of isomalt& maltitol:≤ 2.0 %
- USP - Related Substances: Unspecified impurities:≤ 0.10 %
- USP - Related Substances: Total impurities:≤ 2.0 %
- USP - Loss on Drying at 105°C:≤ 0.5 %
- USP - Melting Point:165 - 170 °C
- USP - Reducing Sugars:≤ 0.1 %
- USP - Nickel (Ni):≤ 1 ppm
- USP - Appearance of Solution:Passes Test
- USP - Conductivity (uS cm-1):≤ 20 µS/cm
- USP - Total Aerobic Microbial Count:≤ 100 cfu/g
- USP - Total Yeast and Mold Count:≤ 100 cfu/g
- USP - Escherichia coli:Passes Test
- EP/BP - Assay (as C₆H₁₄O₆) (calculated on anhydrous basis):97.0 - 102.0 %
- EP/BP - Conductivity, uS cm-1:≤ 20
- EP/BP - Identification C:Passes Test
- EP/BP - Melting Point:165 - 170 °C
- EP/BP - Loss on Drying:≤ 0.5 %
- EP/BP - Reducing Sugars:≤ 0.1 %
- EP/BP - Related Substances: Impurity A:≤ 2.0 %
- EP/BP - Related Substances: Sum of Impurities B & C:≤ 2.0 %
- EP/BP - Related Substances: Unspecified Impurities, each:≤ 0.10 %
- EP/BP - Related Substances: Total Impurities:≤ 2.0 %
- EP/BP - Appearance of Solution:Passes Test
- Total Aerobic Microbial Count (cfu/g):≤ 1000
- Total Mold and Yeast Count (cfu/g):≤ 100
- EP/BP - Escherichia coli (absent):Passes Test
- Salmonella (absent):Passes Test
- Endotoxin Concentration (EU/g):≤ 10
- Appearance (fine, white crystalline powder):Passes Test
- Not Intended for Parenteral Use:≤ 10
- Only Class 2 solvents (Ethylene Glycol) are likely to be present. All:—
- are below Option 1 limits.:—
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