D(-)-Mannitol 97.0-102.0%, powder, GenAR® USP for biotechnology, Macron Fine Chemicals™

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Management of Change (MOC) category = R

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D(-)-Mannitol 97.0-102.0%, powder, GenAR® USP for biotechnology, Macron Fine Chemicals™
D(-)-Mannitol
Formule: HOH₂C(CH(OH))₄CH₂OH
MW: 182,17 g/mol
Kookpunt: 290…295 °C (4 hPa)
Smeltpunt: 164…169 °C
Dichtheid: 1,49 g/cm³ (20 °C)
Opslagtemperatuur: Kamertemperatuur
MDL-nummer: MFCD00064287
CAS-nummer: 69-65-8
EINECS: 200-711-8
Merck Index: 13,05769
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Specificaties testresultaten

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.

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