Customization: | Available |
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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,the maximum absorption wavelengh is at 245nm | Complies |
By HPLC | Complies | |
Violet vapors are evolved | Complies | |
Acidity | Ph: 5.0~7.0 | 6.1 |
Appearance of Solution | The solution is clear,if show color,it should be not darker than yellow reference comparing solution | Complies |
Water Content | ≤5.00% | 1.80% |
Residue on Ignition | ≤0.10% | 0.02% |
Heavy Metal | ≤10ppm | Complies |
Free Iodine | The toluene layer shows no red color | Complies |
Free Iodide | ≤0.001% | 0.0002% |
Residual Solvent | Butanol ≤50ppm | ND |
Methanol ≤50ppm | ND | |
Chloroform ≤7.5ppm | ND | |
2-Chloroethanol ≤25ppm | ND | |
Relative Substance | Ioversol related compound A: ≤0.10% | 0.06% |
Ioversol related compound B: ≤0.50% | 0.22% | |
Ioversol related compound C: ≤0.10% | 0.08% | |
Individual unspecified related compound: ≤0.10% | 0.07% | |
Total unspecified related compounds: ≤0.20% | 0.13% | |
Total related compounds: ≤1.00% | 0.56% | |
Microbial Limits | ≤5.0EU/g | 1.1EU/g |
Assay (HPLC,basis on drying) |
98.0%~101.0% | 99.40% |
Reference Standard | QR-SOP-QS07-201 Standard | |
Conclusion | The product complied to QR-SOP-QS07-201 Standard. | |
Storage | The product is hygroscopic and odorless,preserve in tight,sealed and light-resistant containers in a cool place |