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.
Sales Specifications
Appearance: White Crystals
Appearance of Solution: Clear
Identification: Complies
Assay % : 98.5- IO1.5
Chloride (as Cl) ppm: < 70 ppm
Loss of Drying,%: <0.2
Heavy Metals%: <0.002%
Lead (as Pb) ppm: <0.05%
Cadmium ppm: <0.05%
Arsenic ppm: <0.05%
Mercury%: 0.0000 I 0
Sulphate (as S04) % :<0.0065%
Residue on Ignition,%: <0.1
Related Compounds Reference As per USP 43 Monogram
Monochloroacetic acid%: As per ICH
Diglycine %: <0.1%
Triglycine %: <0.1%
Glycine anhydride%: <0.1%
Iminodiacetic acid%: <0.1%
Hexamethylenetetramine %: <0.1%
Total Impurities%: <0.1%
Residual Solvents As per JCH guideline Q3C (R8)
Chloroform (mcg/gm): <060 ppm
1,4- Dioxane (mcg/gm): <380 ppm
Methylene Chloride (mcg/gm: <600 ppm
Trichloroethylene: <80 ppm
Hydrolysable substances: As per USP 43
Tapped Density (g/cm3) : 1.1
Bulk Density(g/ cm3): 0.869
Mesh Size: 20 to 80 Mesh
Total Plate Count: <1000 cfu/g
Yeast & Mould: <I00 cfu/g
Coliforms: Negative
E. Coli: Negative
Salmonella: Negative
Staphylococcus Aureus: Negative
This product complies as per USP 43 Reference.
Packing
25 kg carton
