Specificaties testresultaten
GMP Manufactured Product |
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Meets U.S.P Requirements |
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Meets B.P. Chemical Specifications |
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Meets E.P. Chemical Specifications |
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CAUTION: For Manufacturing, processing or repackaging |
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Bulk Pharmaceutical Chemical |
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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 |
EP/BP - Assay (as C₆H₁₄O₆) (calculated on anhydrous basis) |
97.0 - 102.0 % |
EP/BP - Conductivity, uS cm-1 |
≤ 20 |
EP/BP - Identification C |
Passes Test |
EP/BP - Melting Point |
165 - 170 °C |
EP/BP - Loss on Drying |
≤ 0.5 % |
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 - Appearance of Solution |
Passes Test |
Total Aerobic Microbial Count (cfu/g) |
≤ 1000 |
Total Mold and Yeast Count (cfu/g) |
≤ 100 |
EP/BP - Escherichia coli (absent) |
Passes Test |
Salmonella (absent) |
Passes Test |
Endotoxin Concentration (EU/g) |
≤ 10 |
Appearance (fine, white crystalline powder) |
Passes Test |
Not Intended for Parenteral Use |
≤ 10 |
Only Class 2 solvents (Ethylene Glycol) are likely to be present. All |
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are below Option 1 limits. |
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Metallic Residues: No metal catalysts or metal reagents, as defined by |
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EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of |
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this material. |
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