Résultats des tests de spécification
Meets B.P. Chemical Specifications |
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GMP Manufactured Product |
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Meets E.P. Chemical Specifications |
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Preserve in well-closed containers. |
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CAUTION: For Manufacturing, processing or repackaging |
Passes Test |
Bulk Pharmaceutical Chemical |
Passes Test |
NF - Assay (C6H12O6 ) (anhydrous basis) |
98.0 - 102.0 % |
NF - Appearance of Solution |
Passes Test |
NF - Acidity |
Passes Test |
NF - Identification A (IR) |
Passes Test |
NF - Identification B (HPLC) |
Passes Test |
NF - Identification C |
Passes Test |
NF - Optical Rotation [Å]²ºD (+) |
78.0 - 81.5 Degree |
NF - Related Substances: Lactose and 1,6-galactosylgalactose |
≤ 0.6 % |
NF - Related Substances: Galacturonic acid |
≤ 0.6 % |
NF - Related Substances: Dextrose |
≤ 0.6 % |
NF - Related Substances: Tagatose |
≤ 0.6 % |
NF - Related Substances: Dulcitol |
≤ 0.6 % |
NF - Related Substances: Arabinose |
≤ 0.6 % |
NF - Related Substances: Any unspecified impurity, each |
≤ 0.2 % |
NF - Related Substances: Total impurities |
≤ 1.0 % |
NF - Barium (Ba) |
Passes Test |
NF - Lead (Pb) |
≤ 0.5 ppm |
NF - Water (H₂O) |
≤ 1.0 % |
NF - Residue on Ignition |
≤ 0.1 % |
EP/BP - Assay (C₆H₁₂O₆)(anhydrous basis) |
97.0 - 102.0 % |
EP/BP - Appearance of Solution |
Passes Test |
EP/BP - Acidity or Alkalinity |
Passes Test |
EP/BP - Identification A (IR) |
Passes Test |
EP/BP - Proteins |
≤ 0.1 % |
EP/BP - Related Substances: Sum of Impurities A and B |
≤ 1.0 % |
EP/BP - Related Substances:Unspecified impurities, each |
≤ 0.3 % |
EP/BP - Related Substances:Total impurities |
≤ 2.0 % |
EP/BP - Specific Optical Rotation [Å]²ºD (+) |
78.0 - 81.5 Degree |
EP/BP - Water (H₂O) |
≤ 1.0 % |
EP/BP - Sulfated Ash |
≤ 0.1 % |
EP/BP - TAMC (cfu/g) |
≤ 100 cfu/g |
Appearance |
Passes Test |
Endotoxin Concentration (EU/g) |
≤ 2.5 |
Glucose |
≤ 0.1 % |
Purity (HPLC) |
≥ 99 % |
Residue on Ignition |
≤ 0.05 % |
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 Mold (USP) |
≤ 100 cfu/g |
Microbial Testing - Total Aerobic Microbial Count (USP) |
≤ 100 cfu/g |
Solution Clarity (300 mg/mL) |
Passes Test |
Solution Color, APHA - For Information Only |
For Information Only |
Trace Impurities - Aluminum (Al), For Information Only |
For Information Only |
Trace Impurities - Arsenic (As), For Information Only |
For Information Only |
Trace Impurities - Cadmium (Cd), For Information Only |
For Information Only |
Trace Impurities - Chromium (Cr), For Information Only |
For Information Only |
Trace Impurities - Copper (Cu), For Information Only |
For Information Only |
Trace Impurities - Iridium (Ir), For Information Only |
For Information Only |
Trace Impurities - Iron (Fe), For Information Only |
For Information Only |
Trace Impurities - Lead (Pb), For Information Only |
For Information Only |
Trace Impurities - Manganese (Mn), For Information Only |
For Information Only |
Trace Impurities - Mercury (Hg), For Information Only |
= 3000 ppm |
Trace Impurities - Molybdenum (Mo), For Information Only |
= 5000 ppm |
Trace Impurities - Nickel (Ni), For Information Only |
= 5000 ppm |
Trace Impurities - Osmium (Os), For Information Only |
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Trace Impurities - Palladium (Pd), For Information Only |
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Trace Impurities - Platinum (Pt), For Information Only |
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Trace Impurities - Rhodium (Rh), For Information Only |
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Trace Impurities - Ruthenium (Ru), For Information Only |
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Trace Impurities - Vanadium (V), For Information Only |
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Trace Impurities - Zinc (Zn), For Information Only |
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Residual Methanol |
≤ 3000 ppm |
Residual Ethanol |
≤ 5000 ppm |
Residual Isopropanol |
≤ 5000 ppm |
Residual Solvents: Only the Class 2 solvent Methanol and the Class 3 |
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Solvent Ethanol are likely to be present. Each is tested and the |
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concentration reported for each batch. |
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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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Plant Derived |
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