| Customization: | Available |
|---|---|
| Certification: | GMP, FDA, ISO |
| Grade Standard: | Medicine Grade |
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| Items | Standards | Results |
| Characteristics | White or off-white amorphous,odorless,hygroscopic powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| By Masculine reaction | Complies | |
| Specific Rotation | -0.5°~+0.5° | 0° |
| Water Content | ≤4.00% | 1.60% |
| Heavy Metal | ≤10ppm | Complies |
| Free Aromatic Amine | ≤0.05% | 0.0042% |
| Free Iodine | The toluene layer shows no red or pink color | Complies |
| Limit of Free Iodide | ≤0.001% | ND |
| Limit of Ionic Compounds | ≤0.02% | ND |
| Limit of Calcium | ≤0.0005% | 0.0001% |
| Residual Solvent | Isopropyl alcohol ≤50ppm | ND |
| Methanol ≤50ppm | ND | |
| Methoxyethanol ≤50ppm | ND | |
| Propryleneglycol monomethyl ether ≤50ppm | ND | |
| 1,3-Dichloro-2-propanol ≤25ppm | ND | |
| Relative Substance | Iodixanol related compound B: ≤0.20% | 0.12% |
| Iodixanol related compound C: ≤0.40% | 0.21% | |
| Iodixanol related compound E: ≤0.30% | 0.19% | |
| Iodixanol related compound F: ≤0.20% | ND | |
| Iodixanol related compound G: ≤0.20% | 0.10% | |
| Iodixanol related compound H: ≤0.60% | ND | |
| Iodexol: ≤0.60% | 0.20% | |
| Overalkylated related compounds: ≤1.00% | 0.20% | |
| Individual unspecified related compound: ≤0.20% | 0.04% | |
| Total unspecified related compounds: ≤0.50% | 0.23% | |
| Total related compounds: ≤1.50% | 1.00% | |
| Microbial Limits | ≤100cfu/g | ND |
| Assay (HPLC,basis on drying) |
98.6%~101.0% | 99.10% |
| Reference Standard | USP36 and TCS09-66-02 Standard | |
| Conclusion | The product complied to current USP and TCS09-602-09 Standard. | |
| Storage | The product is hygroscopic and odorless,preserve in tight,sealed and light-resistant containers in a cool place | |
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