D (-)-Mannitol 97.0-102.0%, pulver USP, Multi-Compendial GMP Manufactured Product, J.T.Baker®
Leverantör: Avantor
Synonyms:
Mannitol, (2R,3R,4R,5R)-Hexane-1,2,3,4,5,6-hexaol
Management of Change (MOC) category = R
2553-01EA
2675
SEK
2553-01
2553-05
2553-07
2553-09
2553-32
2553-34
2553-37
2553-39
2553-38
D (-)-Mannitol 97.0-102.0%, pulver USP, Multi-Compendial GMP Manufactured Product, J.T.Baker®
D (-)-Mannitol
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Formel:
HOH₂C(CH(OH))₄CH₂OH MW: 182,17 g/mol Kokpunkt: 290…295 °C (4 hPa) Smältpunkt: 164…169 °C Densitet: 1,52 g/cm³ Storage Temperature: Omgivande |
MDL Number:
MFCD00064287 CAS nummer: 69-65-8 EINECS: 200-711-8 Merck Index: 13,05769 |
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Specifikation testresultat
| GMP Manufactured Product | 97.0 - 102.0% |
| Meets E.P. Chemical Specifications | Passes Test |
| Meets U.S.P Requirements | ≤2.0% |
| Meets B.P. Chemical Specifications | ≤2.0% |
| Meets J.P. Chemical Specifications | ≤0.10% |
| CAUTION: For Manufacturing, processing or repackaging | ≤2.0% |
| Bulk Pharmaceutical Chemical | ≤0.5% |
| 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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