China Made Irbesartan Powder Pharmaceutical Chemicals CAS 138402-11-6, Find details about China API, Pharmaceutical from China Made Irbesartan Powder Pharmaceutical Chemicals CAS 138402-11-6
Batch No. | HF161118 | Quantity | 1110kgs |
Mfg. Date | Nov.18, 2016 | Package | As required |
Rep. Date | Nov.25, 2016 | Exp. Date | Nov.17, 2018 |
Items | Standards | Results | |
Appearance | White or off-white amorphous,odorless,hygroscopic powder | Complies | |
Identification | By IR | Complies | |
By UV | Complies | ||
By TLC | Complies | ||
By Masculine reaction | Complies | ||
Specific Rotation | -0.5°~+0.5° | 0° | |
Water Content | ≤3.00% | 1.50% | |
Heavy Metal | ≤10ppm | Complies | |
Free Aromatic Amine | ≤0.05% | 0.01% | |
Free Iodine | Complies with standard | Complies | |
Free Iodide | ≤0.001% | ND | |
Ionic Compounds | ≤0.01% | ND | |
Residual Solvent | Isopropyl alcohol ≤50ppm | 1ppm | |
Methanol ≤50ppm | 1ppm | ||
Methoxyethanol ≤20ppm | 2ppm | ||
N-Butanol ≤50ppm | 1ppm | ||
3-Chloro-1,2-propanedio ≤25ppm | ND | ||
Color Of Solution | 400nm:≤0.180 | 0.137 | |
420nm≤0.030 | 0.006 | ||
450nm≤0.015 | 0.000 | ||
Related Substance | Impurity A: ≤0.30% | 0.14% | |
O-alkylated compounds:≤0.50% | 0.48% | ||
Any individual impurity:≤0.10% | 0.04% | ||
The total impurities:≤0.30% | 0.13% | ||
Assay (HPLC,basis on drying) | 98.5%~102.0% | 99.10% | |
Reference Standard | USP36 and TCS09-602-09 Standard | ||
Conclusion | The product complied to USP36 and TCS09-602-09 Standard. | ||
Storage | The product is hygroscopic and odorless,preserve in tight,sealed and light-resistant containers in a cool place |