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D(-)-Manitol 97.0-102.0% (dry basis), powder USP, Multi-Compendial GMP Manufactured Product, J.T. Baker®

Dodávateľ: Avantor


Management of Change (MOC) category = R

2553-37EA 2045.52 EUR
2553-37 2553-07 2553-34 2553-32 2553-01 2553-09 2553-38 2553-05 2553-39 2553-08
D(-)-Manitol 97.0-102.0% (dry basis), powder USP, Multi-Compendial GMP Manufactured Product, J.T. Baker®
D(-)-Manitol
Vzorec: HOH₂C(CH(OH))₄CH₂OH
Mw: 182,17 g/mol
Teplota varu: 290…295 °C (4 hPa)
Teplota tavenia: 164…169 °C
Hustota: 1,52 g/cm³
Skladovacia teplota: Ambient
Číslo MDL: MFCD00064287
Číslo CAS: 69-65-8
EINECS: 200-711-8
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Výsledky špecifikačného testu

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.

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