Résultats des tests de spécification
GMP Manufactured Product |
Passes Test |
Store and ship product between 2 and 8 °C |
5.00 - 7.00 |
CAUTION: For Manufacturing, processing or repackaging |
≤1% |
Appearance (white to off-white solid) |
Passes Test |
Identification (IR) |
Passes Test |
pH of 5% Solution |
5.00 - 7.00 |
Specific Rotation @ 25 °C |
-34.5 - -28.5 Degree |
Melting Point |
110 - 122 °C |
Water (H₂O), For Information Only |
≤5000 ppm |
Purity (by HPLC) (anhydrous basis) |
≥98 % |
Assay (by HPLC) (anhydrous basis) |
98 - 102 |
Endotoxin Concentration, EU/g |
–34.5 - –28.5° |
Residual Methanol |
≤3000 ppm |
Residual Ethanol |
≤5000 ppm |
Residual Isopropanol |
≤5000 ppm |
Residual Ethyl Acetate |
≤5000 ppm |
Total Aerobic Microbial Count |
≤100 cfu/g |
Total Yeast and Mold Count |
≤100 cfu/g |
Biological Induction Characterization (induction response @ 1mM) |
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Arsenic (As), For Information Only |
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Cadmium (Cd), For Information Only |
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Mercury (Hg), For Information Only |
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Lead (Pb), For Information Only |
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Cobalt (Co), For Information Only |
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Nickel (Ni), For Information Only |
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Vanadium (V), For Information Only |
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Silver (Ag), For Information Only |
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Gold (Au), For Information Only |
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Iridium (Ir), For Information Only |
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Osmium (Os), For Information Only |
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Palladium (Pd), For Information Only |
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Platinum (Pt), For Information Only |
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Rhodium (Rh), For Information Only |
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Ruthenium (Ru), For Information Only |
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Selenium (Se), For Information Only |
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Thallium (Tl), For Information Only |
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Barium (Ba), For Information Only |
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Chromium (Cr), For Information Only |
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Copper (Cu), For Information Only |
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Lithium (Li), For Information Only |
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Molybdenum (Mo), For Information Only |
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Antimony (Sb), For Information Only |
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Tin (Sn), For Information Only |
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Aluminum (Al), For Information Only |
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Iron (Fe), For Information Only |
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Manganese (Mn), For Information Only |
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Zinc (Zn), For Information Only |
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Residual Solvents: The Class 3 solvents Ethanol, Isopropanol, Ethyl |
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Acetate and the Class 2 solvent Methanol are likely to be present. These solvents are quantified and reported on each batch. No other |
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Class 1,2,3, or other solvents are used or produced in the production |
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process. Dioxane was not used in the manufacturing process. |
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Bacterial Induction characterization: Test performed at 1 mM of IPTG (E. |
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Coli. protein expression) |
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IPTG is highly hygroscopic. Allow packaging/container to equilibrate to |
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room temperature before opening for analysis. Ensure sample is kept dry |
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(such as in a desiccator) after opening. |
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