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Glycine 98.5-101.5% (dry basis) USP, Multi-Compendial, J.T.Baker®

Supplier: AVANTOR PERFORMANCE MATERIALS

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Management of Change (MOC) category = R

BS10-10EA 0 INR InStock
BS10-10 BS10-D1 BS10-D2 BS10-D3 BS10-SA BS10-ST
Glycine 98.5-101.5% (dry basis) USP, Multi-Compendial, J.T.Baker®
Glycine


Formula: NH₂CH₂COOH
MW: 75.07 g/mol
Boiling Pt: 181
Melting Pt: 83
 MDL Number: MFCD00008131
CAS Number: 56-40-6
Merck Index: 13,04504
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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
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)
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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