Complaint
| Items | Specifications | Results |
| Appearance | White or almost white, hygroscopic powder | Conforms |
| Solubility | Very soluble in methanol and ethanol, sparingly soluble in chloroform, practically insoluble in water. | Conforms |
| Absorbance | Not more than 0.02 at 420nm(1/20 methanol solution) | <0.01 |
| Identification | ||
| A | IR infrared absorption spectrum is identical to that of valsartan reference standard | Conforms |
| B | HPLC the retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the assay. | Conforms |
| Water | NMT 2.0% | 1.1% |
| Residue on ignition | NMT 0.1% | <0.1% |
| Heavy compounds | NMT 0.001% | <0.001% |
| Related compounds | ||
| Related compound A | NMT 1.0% | 0.36% |
| Related compound B | NMT 0.2% | 0.01% |
| Related compound C | NMT 0.1% | ND |
| Any other unspecified impurity | NMT 0.1% | 0.06% |
| Total impurities (not include related compound A) | NMT 0.3% | 0.14% |
| Assay | 98.0%~102.0% of C24H29N5O3, Calculated on the anhydrous basis | 101.3% |
| Residual solvents | ||
| Ethylacetate | NMT 5000ppm | ND |
| Methylene chloride | NMT 600pppm | ND |
| Methanol | NMT 3000ppm | ND |
| Toluene | NMT 890ppm | ND |
| DIMETHYLFORMAMIDE | NMT 880ppm | ND |
| Particle size | Reference | D50:11um D90232um |
| Bulk density | Reference | 0.36g/ml |
| Tapped density | Reference | 0.57g/ml |
| Conclusion: it complies with all the requirement of USP37. | ||
| Abaloparatide | octenidine dihydrochloride | ABT-263 |
| Abemaciclib | O-Desmethylgefitinib | ABT-737 |
| Abiraterone | Osimertinib Mesylate | AZD0328 |
| acalabrutinib | Pacritinib | AZD1236 |
| ALTIRATINIB | Pazopanib HCL | AZD-1480 |
| amfonelic acid | Peficitinib | AZD1656 |
| Anlotinib | Pegdinetanib | AZD1775 |
| Asciminib | ponatinib | AZD1981 |
| Atipamezole HCl | Pyrotinib | AZD2014 |
| Atuveciclib | R788(FOSTAMATINIB DISODIUM) | AZD4017 |
| AV-951 | Radotinib | AZD4573 |
| Avapritinib | ramelteon | AZD5069 |
| Axitinib | Refametinib | AZD5153 |
| Bafetinib | Ribociclib | AZD5213 |
| bendamustine hydrochloride | Riviciclib hydrochloride | AZD5904 |
| Binimetinib | ruxolitinib | AZD7325 |
| Bosutinib | Saracatinib | AZD9150 |
| brigatinib | Savolitinib | Batimastat |
| Cabozantinib | Semaxanib | BMS202 |
| Cabozantinib Maleate | Simotinib HCl | BMS-214662 |
| Capmatinib | Solcitinib | Carfilzomib |
| Cediranib | Sonolisib | CEP-40783 |
| Cerdulatinib | Sulfatinib | CO-1686 |
| Chiauranib | sunitinib | darolutamide |
| Cinchocaine HCL | Sunitinib Maleate | EDO-S101 |
| Cipatinib | Teniposide | emodepside |
| Cobimetinib | Toceranib | EPZ-6438 |
| Dacomitinib | Tofacitinib citrate | IPI-145 |
| dasatinib | trametinib | LDE225 HCL |
| Decernotinib | Vandetanib | MK2206 |
| Donafenib | Volitinib | OSI-027 |
| dovitinib | Voruciclib hydrochloride | OTSSP167 |
| E7449 | WORTMANNIN | PD 98059 |
| Entospletinib | Zibotentan(ZD4054) | PF-04691502 |
| Erdafitinib | zuclopenthixol | PI-103 |
| Erlotinib | larotrectinib | PLX3397 |
| etoposide | Lerociclib dihydrochloride | PLX4720 |
| Famitinib | Lesogaberan AZD3355 | PP-121 |
| Filgotinib | levatinib | PQR309/Bimiralisib |
| Firocoxib | Lorlatinib | Sapanisertib |
| Flumatinib | Maraviroc | selinexor |
| Foretinib | Masitinib mesylate | S-Ruxolitinib |
| Fostamatinib | Mocetinostat | TAE684 |
| Fruquintinib | neratinib | Tafamidis |
| Gefitinib | tenapanor | |
| Gilteritinib | Verteporfin | |
| Golvatinib | WYE-354 | |
| Henatinib | WYE-687 | Atezolizumab |
| Icotinib | 4-IPP | Avelumab |
| imatinib | A-770041 | Durvalumab |
| imatinib mesylate | MLN4924 | Pembrolizumab |
| Lapatinib | OTX-015 | Pertuzumab |
| lapatinib ditosylate | PLX3397 Pexidartinib | Ramucirumab |
| Midostaurin | WAY-600 | |
| nilotinib | WEHI-539 | |
| Oclacitinib maleate | WYE-125132 |
| Shipping Terms | ||
| By Express | By Air | By Sea |
| Suitable for under 50kg Fast:3-4 days High cost Door to door service Easy to pick up the goods | Suitable for more than 50kg Fast:3-4 days High cost Airport to airport Professional broker needed | Suitable for more than 500kg Slow:15-30 days Low cost Port to port Professional broker needed |
