D-(-)-Mannitol 97.0-102.0%, powder, GenAR® USP for biotechnology, Macron Fine Chemicals™
Supplier: Avantor
Management of Change (MOC) category = R
7781-04EA
0
EUR
7781-04
7781-88
D-(-)-Mannitol 97.0-102.0%, powder, GenAR® USP for biotechnology, Macron Fine Chemicals™
D(-)-Mannitol
Formula:
HOH₂C(CH(OH))₄CH₂OH Boiling Pt: 290…295 °C (4 hPa) Melting Pt: 164…169 °C Density: 1.49 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00064287 CAS Number: 69-65-8 EINECS: 200-711-8 Merck Index: 13,05769 |
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) | 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. | — |
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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