D-(-)-Mannitol 97.0-102.0% (dry basis), powder USP, Multi-Compendial GMP Manufactured Product, J.T.Baker®
Supplier: Avantor
Certificates
About this item
Synonyms: Mannitol, (2R,3R,4R,5R)-Hexane-1,2,3,4,5,6-hexaol
CAS Number:69-65-8
:
Formula:HOH₂C(CH(OH))₄CH₂OH
MDL Number:MFCD00064287
Boiling Pt:290…295 °C (4 hPa)
Melting Pt:164…169 °C
Density:1.52 g/cm³
Molecular Weight:182.17 g/mol
Merck Index:13,05769
:Management of Change (MOC) category = R
Storage Temperature:Ambient
EINECS:200-711-8
Specifications
- Environmentally Preferable:
Specifications
Specification Test Results
- GMP Manufactured Product:97.0 - 102.0%
- Meets E.P. Chemical Specifications:Passes Test
- Meets U.S.P Requirements:≤2.0%
- Meets B.P. Chemical Specifications:≤2.0%
- Meets J.P. Chemical Specifications:≤0.10%
- CAUTION: For Manufacturing, processing or repackaging:≤2.0%
- Bulk Pharmaceutical Chemical:≤0.5%
- 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
- USP - Bacterial Endotoxins, IU/g:≤ 2.5
- EP/BP - Assay (as HOCH₂(CHOH)₄CH₂OH) (dried basis):97.0 - 102.0 %
- EP/BP - Identification C:Passes Test
- EP/BP - Melting Point:165 - 170 °C
- EP/BP - Appearance of Solution:Passes Test
- EP/BP - Conductivity, uS cm-1:≤ 20
- 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 - Loss on Drying:≤ 0.5 %
- EP/BP - Escherichia coli:None Detected
- EP/BP - Salmonella:None Detected
- EP/BP - Total Yeast and Mold Count:≤ 100 cfu/g
- EP/BP - Total Aerobic Microbial Count:≤ 100 cfu/g
- EP/BP Endotoxin Concentration, <2.5 IU/g:Passes Test
- JP - Assay (dried basis):97.0 - 102.0 %
- JP - Identification:Passes Test
- JP - Related Substances: Sorbitol:≤ 2.0 %
- JP - Related Substances: Sum of isomalt & maltitol:≤ 2.0 %
- JP - Related Substances: Unspecified impurities:≤ 0.10 %
- JP - Related Substances: Total impurities:≤ 2.0 %
- JP - Heavy Metals (as Pb):≤ 5 ppm
- JP - Loss on Drying at 105°C:≤ 0.5 %
- JP - Melting Point:165 - 170 °C
- JP - Glucose:≤ 0.1 %
- JP - Nickel (Ni):≤ 1 ppm
- JP - Clarity and Color of Solution:Passes Test
- JP - Conductivity (uS cm-1):≤ 20 µS/cm
Specification Test Results
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