JT Baker® 0582-07 Glycine, USP Grade, Multi-Compendial Grade, 12Kg Poly Pail
- 12Kg Poly Pail
- Manufacturer Part No: JT-0582-07
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Details
Product Specifications
TEST | SPECIFICATION |
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
Meets U.S.P Requirements | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
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 - Heavy Metals (as Pb) | <= 0.002 % |
USP - Hydrolyzable Substances | Passes Test |
USP - Assay (C₂H₅NO₂) (dried basis) | 98.5 - 101.5 % |
USP - Endotoxin Concentration (EU/g) | <= 2.5 |
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 - Heavy Metals (as Pb) | <= 10 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. |
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Product Specifications
TEST | SPECIFICATION |
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
Meets U.S.P Requirements | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
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 - Heavy Metals (as Pb) | <= 0.002 % |
USP - Hydrolyzable Substances | Passes Test |
USP - Assay (C₂H₅NO₂) (dried basis) | 98.5 - 101.5 % |
USP - Endotoxin Concentration (EU/g) | <= 2.5 |
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 - Heavy Metals (as Pb) | <= 10 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. |