Imprimer

D(-)-Mannitol 97,0-102,0, powder, GenAR® USP Biotechnology, Macron Fine Chemicals™

Marques : Avantor
Ratings: Ecrire un avis

Total Evaluation: 0
Moyenne des Notes : 0.0 sur 5

Synonyme(s): Mannitol, (2R,3R,4R,5R)-Hexane-1,2,3,4,5,6-hexaol

M.O.C. Category R

7781-04EA 0 EUR
7781-04 7781-88
D(-)-Mannitol 97,0-102,0, powder, GenAR® USP Biotechnology, Macron Fine Chemicals™
D(-)-Mannitol
Formule: HOH₂C(CH(OH))₄CH₂OH
Poids moléculaire: 182.17 g/mol
Point d'ébullition: 290…295 °C (4 hPa)
Point de fusion: 164…169 °C
Densité: 1.49 g/cm³ (20 °C)
Température de stockage: Température ambiante
Numéro MDL: MFCD00064287
Numéro CAS: 69-65-8
EINECS: 200-711-8
Indice Merck: 13,05769
https://digitalassets.avantorsciences.com/adaptivemedia/rendition?id=163f556dca45086e05ff490ddc8eeb65d04aea05&vid=408e3f5566e309064ce68988cdd160305c5b8c0a&prid=web&clid=SAPDAM

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Résultats des tests de spécification

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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