Résultats des tests de spécification
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. |
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Maximum Endotoxin Concentration: 2.5 IU/g |
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No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |
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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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