 |
| Items | Specifications | Results | |||
| Appearance | off white to creamy powder | confirmed | |||
| Bulk Density | NLT0.55g/ml | 99.72% | |||
| As tapped Density | Meets the requirements of USP37 | confirmed | |||
| Assay | More than 90% | 90.47% | |||
| A. infrared Absorption | Meets the requirements of USP37 | < 0.06% | |||
| B. Tests for Sodium | Meets the requirements of USP37 | 0.05% | |||
| Absorb | ＜0.35a.u.(5.0% water solut-420nm) | 0.24a.u. | |||
| pH | 5.5-7.5 | 6.34% | |||
| Loss on Drying | ≤10% | 8.24% | |||
| Residue on Ignition | ≤20%-30% (dry base) | 25.60% | |||
| Chloride | ≤0.5% | confirmed | |||
| Sulfate | ≤0.24% | confirmed | |||
| Protein | ≤5.0% | confirmed | |||
| Heavy metals | ≤20ppm | confirmed | |||
| Iron | ≤10ppm | confirmed | |||
| Lead | ≤0.5ppm | confirmed | |||
| Arsenic | ≤3.0ppm | confirmed | |||
| Mercury | ≤0.5ppm | confirmed | |||
| Organic volatile impurities | Meets the requirements of USP37 | confirmed | |||
| Electrophoretic purity | ≤1% | confirmed | |||
| Total Bacteria count | ≤1000cfu/g | confirmed | |||
| Yeast&Mold | ≤100cfu/g | confirmed | |||
| E.Coli | Negative | Negative | |||
| Salmonella | Negative | Negative | |||
| Staphylococcus Aureus | Negative | Negative |
| Items | Specifications | Results | |||
| Appearance | off white to creamy powder | confirmed | |||
| Bulk Density | NLT0.55g/ml | 99.72% | |||
| As tapped Density | Meets the requirements of USP37 | confirmed | |||
| Assay | More than 90% | 90.47% | |||
| A. infrared Absorption | Meets the requirements of USP37 | < 0.06% | |||
| B. Tests for Sodium | Meets the requirements of USP37 | 0.05% | |||
| Absorb | ＜0.35a.u.(5.0% water solut-420nm) | 0.24a.u. | |||
| pH | 5.5-7.5 | 6.34% | |||
| Loss on Drying | ≤10% | 8.24% | |||
| Residue on Ignition | ≤20%-30% (dry base) | 25.60% | |||
| Chloride | ≤0.5% | confirmed | |||
| Sulfate | ≤0.24% | confirmed | |||
| Protein | ≤5.0% | confirmed | |||
| Heavy metals | ≤20ppm | confirmed | |||
| Iron | ≤10ppm | confirmed | |||
| Lead | ≤0.5ppm | confirmed | |||
| Arsenic | ≤3.0ppm | confirmed | |||
| Mercury | ≤0.5ppm | confirmed | |||
| Organic volatile impurities | Meets the requirements of USP37 | confirmed | |||
| Electrophoretic purity | ≤1% | confirmed | |||
| Total Bacteria count | ≤1000cfu/g | confirmed | |||
| Yeast&Mold | ≤100cfu/g | confirmed | |||
| E.Coli | Negative | Negative | |||
| Salmonella | Negative | Negative | |||
| Staphylococcus Aureus | Negative | Negative |
