Glycine (Ph. Eur, BP, USP) GMP - IPEC grade

Melting Point:

232 °C

Solubility:

water 250 g/l at 20 °C

Physical Description:

solid

Product Code:

631340

Product Name:

Glycine (Ph. Eur, BP, USP) GMP - IPEC grade

Quality Name:

GMP - IPEC grade

Specifications:

Assay (Perchl. Ac.) (calc. a.d.s.): 98.5 - 101.0 %
Identity according to Pharmacopoeias:
(A Ph. Eur / USP): IR passes test
(B Ph. Eur): passes test
(C Ph. Eur): passes test
pH of 5% solution: 5.9-6.4

Maximum limit of impurities
Appearance of solution
Appearance Transparent < formazin I < 3 NTU: passes test
Appearance Colour: < Y7
Loss on drying at 105°C: 0.2%
Residue on ignition (as SO4): 0.1 %
Ammonium (NH4): 0.02 %
Sulfate (SO4): 0.0065%
Residual solvents (Ph.Eur/USP): passes test
Hydrolizable substances: passes test
Chlorides (Cl): 0.007%
Related Substances (HPLC)
Glycine anhidride: 0.10 %
Diglycine: 0.10 %
Triglycine: 0.10 %
Every not specified impurity: 0.10 %
Total impurities: 0.2 %
Ninhydrin positive substances
Individual: 0.10 %
Total: 1.0 %
Monochloroacetic acid: 0.10 %
Iminodiacetic acid: 0.10 %
Hexamethylenetetramine: 0.10 %