ISO 9001:2015
| Product Name: | PF-04965842(Abrocitinib) | Catalogue Number: | GR-78323835 |
| Batch Size: | 5KG | Lot Number: | 20230803 |
| CAS Number: | 1622902-68-4 | Production Date: | |
| Molecular Formula: | C14H21N5O2S | Report Date: | 2023-08-03 |
| Molecular Weight: | 323.42 | Expiry Date: | |
| Storage: | Room temperature, Protected from light and Sealed |
| Test Items | Specifieation | Results |
| Appearance | White to light purple or light pink powder | Conforms |
| Purity | ≥98.0% | 99.7% |
| Melting point | 187.0~192.0℃ | Conforms |
| Isomer | ≤0.1% | ND |
| Single impurity | ≤0.1% | 0.02% |
| Total Impurities | ≤1.0% | 0.03% |
| Water | ≤0.5% | 0.1% |
| Ignition residue | ≤1.0% | 0.06% |
| Heavy metals | ≤20 ppm | Conforms |
| Particle size distribution | D90≤150μm | 89.39μm |
| Methanol | ≤0.3% | ND |
| Ethyl alcohol | ≤0.5% | 0.08% |
| Tetrahydrofuran | ≤0.072% | 0.001% |
| Dichloromethane | ≤0.06% | ND |
| Ethyl acetate | ≤0.5% | ND |
| 2-Methyltetrahydrofuran | ≤0.10% | ND |
| Total aerobic microbial count | ≤1000cfu/g | Conforms |
| Total combined moulds and yeasts | ≤100cfu/g | Conforms |
| Escherichia Coli | ND | ND |
| Salmonella sp | ND | ND |
| signature | ||
Prepared by: |
Reviewed by: |
Aproved by General manager: |
| Date: | Date: | Date: |
