Glycine USP

Applications

Glycine is an excipient in pharmaceutical formulations, stabilizing proteins and improving drug absorption. It’s also used in some urologic procedures as an irrigating fluid.

Glycine 20-80 Mesh USP/NF/FCC/E640

WC Code :07-021-01

Specifications

Appearance Identification: White, odorless, crystalline powder
Infrared Absorption: Samples 1.0- 1.5 mg were taken by tablet pressing method and placed in a mortar with dispersant. The spectra were determined by infrared spectrophotometer. If the spectra obtained in the solid state show differences, dissolve the substance to be examined and the reference substance separately in the minimum volume of ethanol (60 per cent v/v),evaporate to dryness and record the spectra again.
Assay (on dry basis),(%) : 98.5 – 101.5
Chloride, (%): ≤0.007
Loss on drying (105℃ ,2h),(%) ≤0.20
Residue on Ignition (as sulfated ash), (% ): ≤0.10
Related Compounds, (%) : ≤0.05
PH Value(50g/L water solution) :5.5–7.0
Arsenic(as As),(mg/kg) : ≤1
Lead(as Pb),(mg/kg): ≤1
Heavy metals(as Pb),(mg/kg): ≤10
Mercury(as Hg),(mg/kg) : ≤0.1
Cadmium, (mg/kg): ≤1
Clarification Experiment/Appearance of solution: Pass
Hydrolyzable substances : Pass
Sulfate (%) : ≤0.0065
Total Plate Count, (cfu/g): ≤1000
Mold/Yeast Count, (cfu/g): ≤100
Enterobacteriaceae, (cfu/g) : ≤10
S.Aureus, (cfu/g) : ≤10
Salmonella E.coil : Negative in 25g
Conclusion: The quality in conformity with USP-NF/FCC/E640 STANDARD. Micro-organism and biological parameters are tested once annually.