D-(-)-Mannitol 97.0-102.0% (dry basis), powder USP, Multi-Compendial GMP Manufactured Product, J.T.Baker®
Fournisseur: AVANTOR PERFORMANCE MATERIAL LLC
MOC : Réglementé
A propos de cet article
Synonymes: Mannitol,(2R,3R,4R,5R)-Hexane-1,2,3,4,5
Formule:HOH₂C(CH(OH))₄CH₂OH
MW: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)
Numéro MDL:MFCD00064287
Numéro CAS:69-65-8
Index Merck:13,05769
:Length:
:Width:
:Height:
:Ø
:Thickness:
:97,0-102,0
:Management of Change (MOC) category = R
:Boiling Pt:
:Boiling Pt: 290 to 295 °C (4 hPa)
:Melting Pt:
:Melting Pt: 164 to 169 °C
:Flash Pt:
:Flash Pt:
:M.W. 182.17 g/mol
:D-(-)-Mannitol
Température d'entreposage:Ambient
EINECS:200-711-8
:164…169 °C
:290…295 °C (4 hPa)
:M.O.C. Category R
Restricted Products: To process your orders without delay, please provide the required business documentation to purchase this product.
To order chemicals, medical devices, or other restricted products please provide ID that includes your business name & shipping address via email [email protected] or fax 484.881.5997 referencing your VWR account number. Acceptable forms of ID are:
- • State issued document with your organization's Federal Tax ID Number
- • State issued document with your organization's Resale Tax ID Number
- • City or County issued Business License
- • State Department of Health Services License
- • Any other ID issued by the State that includes the business name & address
* ATTN: California Customers may require additional documentation as part of the CA Health & Safety Code. Products that fall under this regulation will be placed on a mandatory 21-day hold after documentation is received. VWR will not lift restrictions for residential shipping addresses.
Résultats des tests de spécification
- GMP Manufactured Product:
- Meets E.P. Chemical Specifications:
- Meets U.S.P Requirements:
- Meets B.P. Chemical Specifications:
- Meets J.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
- 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
- Suitable for use in the manufacture of parenteral dosage forms.:
- Maximum Endotoxin Concentration: 2.5 IU/g:
- No Class 1,2,3 or other solvents are used or produced in the:
- manufacturing or purification of the product.:
- Elemental Impurities (USP 232, EP 5.20) - Information on elemental:
- impurities for this product is available on the associated Product:
- Regulatory Data Sheet and elemental impurity profile report.:
Résultats des tests de spécification
Customers Who Bought This Also Bought