Analysis | Specifi cation | R e sult | Tes t Method |
Appearance | White to off white powder powder | Complies | V isual |
Appearance
of solution (10% w / v in water ) |
Clear and colorless | Complies | Visual |
B ulk density ( g / ml ) | ≥0.3g/ml | 0.33g/ml | USP <616> |
Tapped Densit y | ≥0.4g/ml | 0.52g/ml | USP <616> |
Substances | Total impurities≤2.0% | 1.3% | GSH USP monograph |
Rel ated | L-glutathine oxidized | ≤ 1.5% | GSH USP monograph |
Iden tification | S.O.R(- 15.5° ~-17.5°) | - 16. 1° | USP<781S> |
Infrared | Positive | USP< 197K> | |
Loss on drying (3 h at 105ºC) | ≤0.5% | 0. 1% | USP39 <731> |
Resi due of Ignition | ≤0. 1% | <0. 1% | USP39 <281> |
Assay (dry basis) | 98%- 101. 1% | 99.50% | GSH USP monograph |
Ammonium | ≤200ppm | Complies | GSH USP monograph |
Chloride | ≤2 00ppm | Complies | U SP <241> |
Sul fate | ≤3 00ppm | Complies | U SP <221> |
I ron | ≤ 10ppm | Complies | U SP <221> |
P b | ≤0.5ppm | Complies | ICP - MS |
As | ≤0 .5ppm | Complies | ICP - MS |
H g | ≤0 .5ppm | Complies | ICP - MS |
C d | ≤0 .5ppm | Complies | ICP - MS |
Total Plate C ount | ≤ 10000cfu/g | N . D | USP 3 9 <61> |
Yeast & Mold | ≤ 100cfu/g | N . D | USP 3 9 <61> |
E.Co li | Nega tive | Complies | USP 3 9 <62> |
S. aure us | Nega tive | Complies | USP 3 9 <62> |