D-(-)-Mannitol 97.0-102.0% (dry basis), powder USP, Multi-Compendial GMP Manufactured Product, J.T.Baker®
Supplier: AVANTOR PERFORMANCE MATERIAL LLC
Synonyms:
Mannitol
, (2R,3R,4R,5R)-Hexane-1,2,3,4,5,6-hexaol
Management of Change (MOC) category = R
2553-37
2553-08
BAKR2553-08
2553-QM
2553-39
BAKR2553-01
BAKR2553-05
BAKR2553-07
2553-07
BAKR2553-QM
BAKR2553-09
2553-32
2553-38
2553-05
2553-09
CAJT2553-5CS
11525.47
CAD
CAJT2553-5
CAJT2553-7
CAJT2553-9
JT2553-5
JT2553-QM
JT2553-7
JT2553-9
JT2553-38
JT2553-37
JT2553-32
CAJT2553-QM
JT2553-1
CAJT2553-08
JT2553-39
JT2553-08
D-(-)-Mannitol 97.0-102.0% (dry basis), powder USP, Multi-Compendial GMP Manufactured Product, J.T.Baker®
D(-)-Mannitol
|
Formula:
HOH₂C(CH(OH))₄CH₂OH MW: 182.17 g/mol Boiling Pt: 290…295 °C (4 hPa) Melting Pt: 164…169 °C Density: 1.52 g/cm³ |
MDL Number:
MFCD00064287 CAS Number: 69-65-8 Merck Index: 13,05769 |
|
Specification Test Results
| 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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