Résultats des tests de spécification
Meets B.P. Chemical Specifications |
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Meets E.P. Chemical Specifications |
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Meets J.P. Chemical Specifications |
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GMP Manufactured Product |
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Meets U.S.P Requirements |
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CAUTION: For Manufacturing, processing or repackaging |
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Bulk Pharmaceutical Chemical |
Passes Test |
USP - Identification A |
Passes Test |
USP - Identification B |
Passes Test |
USP - Identification C: Water (H₂O) |
≤1.0 % |
USP - Assay (Anhydrous basis) |
97.5 - 102.0 % |
USP - Related substances: Maltose and isomaltose |
≤0.4 % |
USP - Dextrin |
Passes Test |
USP - Related substances: Maltotriose |
≤0.2 % |
USP - Related substances: Fructose |
≤0.15 % |
USP - Related substances: Unspecified impurities, each |
≤0.10 % |
USP - Related substances: Total Impurities |
≤0.5 % |
USP - Color and Clarity of Solution |
Passes Test |
USP - Soluble Starch, Sulfites |
≤15 ppm |
USP - Conductivity (uS cm-1) |
≤20 µS/cm |
EP/BP - Identification A (Specific Rotation (+)) |
52.5 - 53.3 Degree |
EP/BP - Identification B |
Passes Test |
EP/BP - Identification E |
Passes Test |
EP/BP - Assay (C₆H₁₂O₆) (anhydrous substance) |
97.5 - 102.0 % |
EP/BP - Appearance of Solution |
Passes Test |
EP/BP - Conductivity, uS cm-1 |
≤20 |
EP/BP - Related Substances: sum of impurities A and B |
≤0.4 % |
EP/BP - Related Substances: impurity C |
≤0.2 % |
EP/BP - Related Substances: impurity D |
≤0.15 % |
EP/BP - Related Substances: unspecified impurities, each |
≤0.10 % |
EP/BP - Related Substances: total impurities |
≤0.5 % |
EP/BP - Dextrins |
Passes Test |
EP/BP - Soluble starch, sulfite |
≤15 ppm |
EP/BP - Water (H₂O) |
≤1.0 % |
Endotoxin Concentration (EU/g) |
≤5.0 |
JP - Identification 1 |
Passes Test |
JP - Identification 2 |
Passes Test |
JP - Water (H₂O) |
≤1.0 % |
JP - Assay (Anhydrous basis) |
97.5 - 102.0 % |
JP - Maltose and isomaltose |
≤0.4 % |
JP - Maltotriose |
≤0.2 % |
JP - Fructose |
≤0.15 % |
JP - Unspecified Impurities, each |
≤0.10 % |
JP - Total Impurities |
≤0.5 % |
JP - Color and Clarity of Solution |
Passes Test |
JP - Soluble Starch, Sulfites |
≤15 ppm |
JP - Conductivity (uS cm-1) |
≤20 µS/cm |
JP - Dextrin |
Passes Test |
JP - Heavy Metals (as Pb) |
≤4 ppm |
Appearance (white, granular powder) |
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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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