Spezifikation Testergebnisse
GMP Manufactured Product |
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CAUTION: For Manufacturing, processing or repackaging |
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Assay (NH₂C(CH₂OH)₃·HCl) |
≥99.0 % |
Appearance (colorless crystals to white crystalline powder) |
Passes Test |
Absorbance of a 1M Solution - 260 nm |
≤ 0.06 |
Absorbance of a 1M Solution - 280 nm |
≤ 0.06 |
Absorbance of a 1M Solution - 400 nm |
≤ 0.01 |
Identification (by IR) |
Passes Test |
Loss on Drying at 105 °C |
≤ 0.5 % |
Water (H₂O)(by Karl Fischer titrn) |
≤ 0.5 % |
Endotoxin Concentration (EU/g) |
≤ 2.5 |
Melting Point |
147 - 153 °C |
pH of 0.5M Solution at 25 °C |
3.5 - 5.0 |
Enzyme Activity - DNase Activity |
Passes Test |
Enzyme Activity - RNase Activity |
Passes Test |
Enzyme Activity - Protease Activity |
Passes Test |
Trace Impurities - Sodium (Na) |
≤ 50.000 ppm |
Trace Impurities - Aluminum (Al) |
≤ 5.000 ppm |
Trace Impurities - Barium (Ba) |
≤ 5 ppm |
Trace Impurities - Bismuth (Bi) |
≤ 5 ppm |
Trace Impurities - Cadmium (Cd) |
≤ 5.000 ppm |
Trace Impurities - Calcium (Ca) |
≤ 10.0 ppm |
Trace Impurities - Cobalt (Co) |
≤ 5.000 ppm |
Trace Impurities - Chromium (CR) |
≤ 5 ppm |
Trace Impurities - Potassium (K) |
≤ 50 ppm |
Trace Impurities - Lithium (Li) |
≤ 5 ppm |
Trace Impurities - Manganese (Mn) |
≤ 5 ppm |
Trace Impurities - Molybdenum (Mo) |
≤ 5 ppm |
Trace Impurities - Nickel (Ni) |
≤ 5.000 ppm |
Trace Impurities - Arsenic (As) |
≤ 1 ppm |
Trace Impurities - Copper (Cu) |
≤ 5 ppm |
Trace Impurities - Iron (Fe) |
≤ 5 ppm |
Trace Impurities - Lead (Pb) |
≤ 1 ppm |
Trace Impurities - Magnesium (Mg) |
≤ 5 ppm |
No Class 1,2,3 or other solvents are used or produced in the |
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manufacturing or purification of the product. |
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Filtered through a 0.2 micron filter. |
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