Complaint
Product name | Pemetrexed disodium 2.5 hydrate |
Synonyms | N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid disodium salt hydrate |
CAS No. | 357166-30-4 |
Molecular formula | 2(C20H19N5Na2O6).5(H2O) |
Molecular weight | 1032.84 |
Structure |
|
Appearance | White or off-white powder |
Assay | 99%HPLC |
Application | Pharmaceutical Intermediates |
| Items | Standards | Results | |
| Appearance | White or off-white powder | Off-white powder | |
| Identification | By HPLC | Complies | |
| Melting Point | 120ºC~130ºC | 126ºC | |
| Loss on Drying | ≤1.00% | 0.21% | |
| Heavy Metals | ≤ 10ppm | Complies | |
| Sulfated Ash | ≤ 0.10% | 0.03% | |
| Content | 17.5%~19.5% | 19.3% | |
| Arsenic Content | ≤ 0.1ppm | 0.09ppm | |
| Lead VContent | ≤ 3.0ppm | 0.50ppm | |
| Content | ≤ 0.1ppm | 0.10ppm | |
| Content | ≤ 0.1ppm | 0.10ppm | |
| Microbiological Test | Coliforms:Negative | Negative | |
| Salmonella: Negative | Complies | ||
| Total plate count: ≤1000 CFU/g | Pass | ||
| Yeast&Mold: ≤50 CFU/g | Pass | ||
| Related Substances | Impurity A: ≤0.30% | 0.18% | |
| Other unknown impurity: ≤0.10% | 0.07% | ||
| Total Impurities: ≤0.50% | 0.42% | ||
| Assay | ≥ 98.0% | 99.50% | |
