Specification Test Results
Meets B.P. Chemical Specifications |
|
Meets E.P. Chemical Specifications |
|
GMP Manufactured Product |
|
Meets JPC (1997) Chemical Specifications |
|
Meets U.S.P Requirements |
|
CAUTION: For Manufacturing, processing or repackaging |
|
Bulk Pharmaceutical Chemical |
|
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 - Residue on Ignition |
≤0.1 % |
USP - Loss on Drying |
≤0.5 % |
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 |
Passes Test |
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 |
Water (H₂O)(by Karl Fischer titrn) |
≤0.5 % |
Enzyme Activity - DNase Activity |
Passes Test |
Enzyme Activity - RNase Activity |
Passes Test |
Enzyme Activity - Protease Activity |
Passes Test |
Trace Impurities - Arsenic (As) |
≤1 ppm |
Trace Impurities - Aluminum (Al) |
≤5.000 ppm |
Trace Impurities - Barium (Ba) |
≤5 ppm |
Trace Impurities - Bismuth (Bi) |
≤5 ppm |
Trace Impurities - Calcium (Ca) |
≤10.0 ppm |
Trace Impurities - Cadmium (Cd) |
≤5.000 ppm |
Trace Impurities - Chromium (CR) |
≤5 ppm |
Trace Impurities - Cobalt (Co) |
≤5.000 ppm |
Trace Impurities - Copper (Cu) |
≤5 ppm |
Trace Impurities - Lithium (Li) |
≤5 ppm |
Trace Impurities - Magnesium (Mg) |
≤5 ppm |
Trace Impurities - Mercury (Hg) |
≤5 ppm |
Trace Impurities - Molybdenum (Mo) |
≤5 ppm |
Trace Impurities - Nickel (Ni) |
≤5.000 ppm |
Trace Impurities - Potassium (K) |
≤50 ppm |
Trace Impurities - Sodium (Na) |
≤50.000 ppm |
Trace Impurities - Strontium (Sr) |
≤5 ppm |
Trace Impurities - Vanadium (V) |
≤5.000 ppm |
Trace Impurities - Zinc (Zn) |
≤5.000 ppm |
No Class 1,2,3 or other solvents are used or produced in the |
|
manufacturing or purification of the product. |
|
Elemental Impurities (USP 232, EP 5.20) - Information on elemental |
|
impurities for this product is available on the associated Product |
|
Regulatory Data Sheet and elemental impurity profile report. |
|