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Physicochemical Specifications:
INSPECTION ITEMS | PRODUCT INDEX | INSPECTION RESULT | TEST METHOD |
Assay % | 98.0%-102.0% | 99.97 | USP42<621> |
Chromatographic Purity % | ≥99.8% | 99.91 | USP42<621> |
DMSO Content % | ≤0.1 | 0.005 | USP42<621> |
Any other individual impurity | ≤0.05% | 0.01 | |
Total Impurities | ≤0.20% | 0.09 | |
Identification | A.Infrared Absorrption | Complies | USP42<196K> |
B.The retention time of the major peak of Sample solution corresponds to that of the standard solution as abtained in the Assay | Complies | USP42 | |
Appearance | White Crystalline | White Crystalline | VISUAL |
Odor | Odorless | Odorless | SMELLING |
Melting Point ℃ | 108.5-110.5 | 108.7 | USP42<741> |
Bulk Density g/ml | ≥0.65 | 0.69 | |
Water Content % | ≤0.10 | 0.09 | USP42<921> |
Pb ppm | ≤0.1 | <0.1 | USP42<231> |
As ppm | ≤0.1 | <0.1 | USP42<231> |
Cd ppm | ≤0.1 | <0.1 | USP42<231> |
Hg ppm | ≤0.1 | <0.1 | USP42<231> |
Residue on Ignition % | <0.10 | 0.01 | USP42<281> |
Coliform (CFU/g) | Negative | Negative | USP42<2021> |
E.Coli (CFU/10g) | Negative | Negative | USP42<2022> |
Yeast/Mold (CFU/g) | <10 | <10 | USP42<2021> |
Salmonella | Negative | Negative | USP42<2021> |
Standard Aerobic Plate Count(CFU/g) | <10 | <10 | USP42<2021> |
Particle Size | 40-60Mesh | Conform | SIEVE |
Solubility | freely soluble in water and acetone, slightly soluble in ether, soluble in methanol. | ||
Physicochemical Specifications:
INSPECTION ITEMS | PRODUCT INDEX | INSPECTION RESULT | TEST METHOD |
Assay % | 98.0%-102.0% | 99.97 | USP42<621> |
Chromatographic Purity % | ≥99.8% | 99.91 | USP42<621> |
DMSO Content % | ≤0.1 | 0.005 | USP42<621> |
Any other individual impurity | ≤0.05% | 0.01 | |
Total Impurities | ≤0.20% | 0.09 | |
Identification | A.Infrared Absorrption | Complies | USP42<196K> |
B.The retention time of the major peak of Sample solution corresponds to that of the standard solution as abtained in the Assay | Complies | USP42 | |
Appearance | White Crystalline | White Crystalline | VISUAL |
Odor | Odorless | Odorless | SMELLING |
Melting Point ℃ | 108.5-110.5 | 108.7 | USP42<741> |
Bulk Density g/ml | ≥0.65 | 0.69 | |
Water Content % | ≤0.10 | 0.09 | USP42<921> |
Pb ppm | ≤0.1 | <0.1 | USP42<231> |
As ppm | ≤0.1 | <0.1 | USP42<231> |
Cd ppm | ≤0.1 | <0.1 | USP42<231> |
Hg ppm | ≤0.1 | <0.1 | USP42<231> |
Residue on Ignition % | <0.10 | 0.01 | USP42<281> |
Coliform (CFU/g) | Negative | Negative | USP42<2021> |
E.Coli (CFU/10g) | Negative | Negative | USP42<2022> |
Yeast/Mold (CFU/g) | <10 | <10 | USP42<2021> |
Salmonella | Negative | Negative | USP42<2021> |
Standard Aerobic Plate Count(CFU/g) | <10 | <10 | USP42<2021> |
Particle Size | 40-60Mesh | Conform | SIEVE |
Solubility | freely soluble in water and acetone, slightly soluble in ether, soluble in methanol. | ||
