Specificaties testresultaten
Meets J.P. Chemical Specifications |
|
Meets U.S.P Requirements |
|
Meets E.P. Chemical Specifications |
|
Meets B.P. Chemical Specifications |
|
GMP Manufactured Product |
|
CAUTION: For Manufacturing, processing or repackaging |
|
Bulk Pharmaceutical Chemical |
Passes Test |
USP - Identification |
Passes Test |
USP - Loss on Drying at 105°C |
≤0.2 % |
USP - Residue on Ignition |
≤0.1 % |
USP - Chloride (Cl) |
≤0.007 % |
USP - Sulfate (SO₄) |
≤0.0065 % |
USP - Hydrolyzable Substances |
Passes Test |
USP - Assay (C₂H₅NO₂) (dried basis) |
98.5 - 101.5 % |
USP - Endotoxin Concentration (EU/g) |
≤2.5 |
USP - Related Compounds: Glycine anhydride |
≤0.1 % |
USP - Related Compounds: Monochloroacetic acid (For Information Only) |
Passes Test |
USP - Related Compounds: Iminodiacetic acid |
≤0.1 % |
USP - Related Compounds: Diglycine |
≤0.1 % |
USP - Related Compounds: Triglycine |
≤0.1 % |
USP - Related Compounds: Hexamethylenetetramine |
≤0.1 % |
USP - Related Compounds: Any unspecified impurity (For Information Only) |
= 0.10 % |
USP - Related Compounds: Total impurities |
≤1.0 % |
EP/BP - Assay (C₂H₅NO₂) (dried basis) |
98.5 - 101.0 % |
EP/BP - Identification A |
Passes Test |
EP/BP - Appearance of Solution |
Passes Test |
EP/BP - pH |
5.9 - 6.4 |
EP/BP - Chloride (Cl) |
≤75 ppm |
EP/BP - Loss on Drying at 105°C |
≤0.5 % |
EP/BP - Ash (sulfated) |
≤0.1 % |
EP/ BP - Related substances: Glycine anhydride |
≤0.10 % |
EP/ BP - Related substances: Diglycine |
≤0.10 % |
EP/ BP - Related substances: Triglycine |
≤0.10 % |
EP/ BP - Related substances: Unspecified impurities, each |
≤0.10 % |
EP/ BP - Related substances: Total impurities |
≤0.2 % |
EP/BP - Ninhydrin Positive Substances - Each Impurity |
≤0.10 % |
EP/BP-Ninhydrin-Positive Substances-Total Impurities |
≤1.0 % |
EP/BP - Ammonium (NH₄) |
≤0.02 % |
JP - Assay (C₂H₅NO₂) (dried basis) |
98.5 - 101.0 % |
JP - Identification |
Passes Test |
JP - pH (1 in 20) |
5.6 - 6.6 |
JP - Clarity and Color of Solution |
Passes Test |
JP - Chloride (Cl) |
≤0.021 % |
JP - Sulfate (SO₄) |
≤0.028 % |
JP - Ammonium (NH₄) |
≤0.02 % |
JP - Heavy Metals (as Pb) |
≤20 ppm |
JP - Arsenic (As) |
≤2 ppm |
JP - Related Substances |
Passes Test |
JP - Loss on Drying at 105°C |
≤0.30 % |
JP - Residue on Ignition |
≤0.10 % |
Only Class 2 Solvents (Methanol) are likely to be present. All are |
|
below Option 1 limits. |
|
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. |
|