Résultats des tests de spécification
Meets JPC (1997) Chemical Specifications |
99.0 - 101.0% |
Meets B.P. Chemical Specifications |
Passes Test |
Meets E.P. Chemical Specifications |
Passes Test |
Meets U.S.P Requirements |
Passes Test |
GMP Manufactured Product |
10.0 - 11.5 |
CAUTION: For Manufacturing, processing or repackaging |
≤1.0% |
Bulk Pharmaceutical Chemical |
≤0.1% |
USP - Assay (C₄H₁₁NO₃) |
99.0 - 101.0 % |
USP - Identification A |
Passes Test |
USP - Identification B |
Passes Test |
USP - Identification C |
Passes Test |
USP - pH (1 in 20) |
10.0 - 11.5 |
USP - Loss on Drying |
≤1.0 % |
USP - Residue on Ignition |
≤0.1 % |
USP - Melting Range(Lower) |
168 - 172 °C |
USP - Melting Range(Upper) |
168 - 172 °C |
EP/BP - Assay (C₄H₁₁NO₃) (dried basis) |
99.0 - 100.5 % |
EP/BP - Identification B (melting point) |
168 - 174 °C |
EP/BP - Identification C |
Passes Test |
EP/BP - Appearance of Solution |
Passes Test |
EP/BP - pH |
10.0 - 11.5 |
EP/BP - Related Substances |
≤1.0 % |
EP/BP - Chloride (Cl) |
≤100 ppm |
EP/BP - Iron (Fe) |
≤10 ppm |
EP/BP - Loss on Drying at 105°C |
≤0.5 % |
EP/BP - Ash (sulfated) |
≤0.1 % |
JPC 1997 - Assay (C₄H₁₁NO₃) (dried basis) |
≥99.0 % |
JPC 1997 - Identification A |
Passes Test |
JPC 1997 - Identification B |
Passes Test |
JPC 1997 - pH |
10.3 - 10.7 |
JPC 1997 - Melting Point |
168 - 172 °C |
JP - Clarity and Color of Solution |
Passes Test |
JPC 1997 - Heavy Metals (as Pb) |
≤8 ppm |
JPC 1997 - Arsenic (As) |
≤1.6 ppm |
JPC 1997 - Loss on Drying |
≤0.5 % |
JPC 1997 - Residue on Ignition |
≤0.10 % |
Assay (C₄H₁₁NO₃) (dried basis) |
≥99.9 % |
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 |
Endotoxin Concentration (EU/g) |
≤2.5 |
Iron (Fe) |
≤1 ppm |
Lead (Pb) |
≤1 ppm |
Ultrapure Bioreagent Specifications |
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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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Manufactured exclusively for Avantor Performance Materials, LLC., by BioSpectra, Inc., Stroudsburg, PA |
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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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