Glycine 98.5-101.5% USP, Multi-Compendial, J.T.Baker®
Supplier: Avantor
Synonyms:
Aminoacetic acid, Glycocoll, H-Gly-OH
0582-01EA
10563.83
INR
0582-01
0582-05
0582-07
0582-09
Glycine 98.5-101.5% USP, Multi-Compendial, J.T.Baker®
Glycine
Formula:
NH₂CH₂COOH MW: 75,07 g/mol Boiling Pt: 181 °C (1013 hPa) Melting Pt: 83 °C Density: 1,64 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00008131 CAS Number: 56-40-6 EINECS: 200-272-2 Merck Index: 13,04504 |
Specification Test Results
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) |
|
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. |
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