| TEST | SPECIFICATION |
| GMP Manufactured Product |
| Meets B.P. Chemical Specifications |
| Meets E.P. Chemical Specifications |
| Meets J.P. Chemical Specifications |
| Meets N.F. Requirements |
| CAUTION: For Manufacturing, processing or repackaging |
| Bulk Pharmaceutical Chemical |
| NF - Identification | Passes Test |
| NF - Appearance of Solution | Passes Test |
| NF - Color Value | <= 45 |
| NF - Conductivity | <= 35 µS/cm |
| NF - Optical Rotation (+) | 66.3 - 67.0 Degree |
| NF - Reducing Sugars | Passes Test |
| NF - Sulfite (SO2) | <= 10 ppm |
| NF - Loss on Drying at 105 ºC | <= 0.1 % |
| EP/BP - Identification A | Passes Test |
| EP/BP - Identification B | Passes Test |
| EP/BP - Identification C | Passes Test |
| EP/BP - Appearance of Solution | Passes Test |
| EP/BP - Conductivity, uS cm-1 | <= 35 |
| EP/BP - Optical Rotation (+) | 66.3 - 67.0 Degree |
| EP/BP - Colour Value | <= 45 |
| EP/BP - Reducing Sugars | Passes Test |
| EP/BP - Sulfite (SO₂) | <= 10 ppm |
| EP/BP - Loss on Drying at 105°C | <= 0.1 % |
| JP - Identification | Passes Test |
| JP - Optical Rotation (+) | 66.3 - 67.0 Degree |
| JP - Color Value | <= 45 |
| JP - Clarity of Solution | Passes Test |
| JP - Dextrins | Passes Test |
| JP - Sulfite (SO₂) | <= 10 ppm |
| JP - Conductivity, uS cm-1 | <= 35 |
| JP - Loss on Drying at 105°C | <= 0.1 % |
| JP - Reducing Sugars | Passes Test |
| Assay (HPLC) | >= 99 % |
| Endotoxin Concentration (EU/g) | <= 0.6 |
| Microbial Testing - Salmonella (USP) | None Detected |
| Microbial Testing - E. coli (USP) | None Detected |
| Microbial Testing - Staphylococcus aureus (USP) | None Detected |
| Microbial Testing - Pseudomonas aeruginosa (USP) | None Detected |
| Microbial Testing - Total Yeast and Molds (USP) | <= 100 cfu/g |
| Microbial Testing - Total Aerobic Microbial Count (USP) | <= 100 cfu/g |
| Microbial Testing -Bile tolerant gram-negative bacteria | None Detected |
| Microbial Testing - Clostridia |
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| 产品资料 |
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