| TEST | SPECIFICATION |
| GMP Manufactured Product |
| Meets B.P. Chemical Specifications |
| Meets E.P. Chemical Specifications |
| Meets J.P. Chemical Specifications |
| Meets U.S.P Requirements |
| CAUTION: For Manufacturing, processing or repackaging |
| Bulk Pharmaceutical Chemical |
| 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 - Heavy Metals (as Pb) | <= 5 ppm |
| 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 - Assay (C₆H₁₂O₆) (dried basis) | 99.5 - 101.0 % |
| JP - Identification | Passes Test |
| JP - Clarity and Color of Solution | Passes Test |
| JP - Acidity | Passes Test |
| JP - Chloride (Cl) | <= 0.018 % |
| JP - Sulfate (SO₄) | <= 0.024 % |
| JP - Heavy Metals (as Pb) | <= 4 ppm |
| JP - Arsenic (As) | |
