D-(-)-Mannitol 97.0-102.0%, powder, GenAR® USP for biotechnology, Macron Fine Chemicals™
Catalog #: CAMK778188
Supplier: AVANTOR PERFORMANCE MATERIAL LLC
CAS Number: 69-65-8
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Specifications
- Packaging:PE pail, screw top
- Size:12 kg
- Cat. no.:CAMK778188
Specifications
Specification Test Results
- 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):
- Not Intended for Parenteral Use:
- Only Class 2 solvents (Ethylene Glycol) are likely to be present. All:
- are below Option 1 limits.:
- Metallic Residues: No metal catalysts or metal reagents, as defined by:
- EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of:
- this material.:
Specification Test Results
About this item
Synonyms: Mannitol,(2R,3R,4R,5R)-Hexane-1,2,3,4,5
Boiling Pt:290…295 °C (4 hPa)
Melting Pt:164…169 °C
Density:1.49 g/cm³ (20 °C)
:Length:
:Width:
:Height:
:Ø
:Thickness:
:97,0-102,0
:Management of Change (MOC) category = R
:Boiling Pt:
:Boiling Pt: 290…295 °C (4 hPa)
:Melting Pt:
:Melting Pt: 164 to 169 °C|Melting Pt: 164…169 °C
:Flash Pt:
:Flash Pt:
:M.W. 182.17 g/mol
Merck Index:13,05769
:D-(-)-Mannitol
Formula:HOH₂C(CH(OH))₄CH₂OH
MW:182.17 g/mol
Storage Temperature:Ambient
MDL Number:MFCD00064287
CAS Number:69-65-8
EINECS:200-711-8
:290…295 °C (4 hPa)
:M.O.C. Category R
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