Specificaties testresultaten
Meets N.F. Requirements |
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GMP Manufactured Product |
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Meets E.P. Chemical Specifications |
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Meets B.P. Chemical Specifications |
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Meets J.P. Chemical Specifications |
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CAUTION: For Manufacturing, processing or repackaging |
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Bulk Pharmaceutical Chemical |
Passes Test |
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 |
None Detected |
Microbial Testing - Candida albicans |
None Detected |
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 |
For Information Only |
Trace Impurities - Molybdenum (Mo), For Information Only |
For Information Only |
Trace Impurities - Nickel (Ni), For Information Only |
For Information Only |
Trace Impurities - Osmium (Os), For Information Only |
For Information Only |
Trace Impurities - Palladium (Pd), For Information Only |
For Information Only |
Trace Impurities - Platinum (Pt), For Information Only |
For Information Only |
Trace Impurities - Rhodium (Rh), For Information Only |
For Information Only |
Trace Impurities - Ruthenium (Ru), For Information Only |
For Information Only |
Trace Impurities - Vanadium (V), For Information Only |
For Information Only |
Trace Impurities - Zinc (Zn), For Information Only |
= 3000 ppm |
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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solvents Ethanol and Isopropanol are likely to be present. Each is |
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tested and the concentration reported for each batch. |
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Elemental Impurities (USP 232, EP 5.20) - Information on elemental |
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impurities for this product is available on the associated Product |
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Regulatory Data Sheet and elemental impurity profile report. |
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Suitable for use in the manufacture of parenteral dosage forms. |
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