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Items of Analysis | Standard of Analysis | Test Results |
Color and Clarity of Solution | The sample solution is clear and not more intensely colored than the reference solution | Passes Test |
Identification | A. Meets the requirement | Passes Test |
B. Meets the requirement | Passes Test | |
C. Water 7.5%-9.5% | 8.6% | |
Assay | 97.5%-102.0% | 99.8% |
Related substances | Maltose and Isomaltose ≤0.4% | 0.07% |
Maltotriose ≤0.2% | 0.01% | |
Fructose ≤0.15% | 0% | |
Unspecified ≤0.10% | 0.01% | |
Total Impurities ≤0.5% | 0.09% | |
Conductivity | ≤20μS/cm | 1.5μS/cm |
Dextrin | The sample dissolves completely | Passes Test |
Soluble Starch, Sulfites | ≤15ppm | <15ppm |
Aerobic Plate Count | ≤1000cfu/g | 10cfu/g |
Moulds and Yeasts | ≤100cfu/g | <10cfu/g |
Escherichia Coli | Negative | Negative |
Bacterial Endotoxin | ≤1.25Eu/g | <0.6Eu/g |
Conclusion | The products meet the requirements of USP43. |
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