ISO 9001:2015
| Product Name: | Salcaprozate Sodium | Catalogue Number: | GR-23669833 |
| Batch Size: | 200KG | Lot Number: | 20230306 |
| CAS Number: | 203787-91-1 | Production Date: | |
| Molecular Formula: | C15H20NNaO4 | Report Date: | 2023-03-06 |
| Molecular Weight: | 301.31 | Expiry Date: | |
| Storage: | Room temperature, Protected from light and Sealed |
| Test Items | Specifieation | Results |
| Appearance | White to off-white powder | Conforms |
| Assay | 98.0% ~ 102.0% | 100.3% |
| Impurity A | ≤0.1% | ND |
| Impurity K | ≤0.1% | 0.005% |
| Single impurity | ≤0.1% | 0.01% |
| Total impurity | ≤0.5% | 0.04% |
| Ethanol | ≤0.5% | 0.07% |
| N,N-Dimethylacetamide | ≤0.1% | 0.05% |
| Particle size distribution | D90≤60 mesh | Conforms |
| Total aerobic microbial count | ≤1000 cfu/g | 65 cfu/g |
| Total combined yeasts/moulds count | ≤100 cfu/g | 20 cfu/g |
| E-coli | ND | ND |
| signature | ||
Prepared by: |
Reviewed by: |
Aproved by General manager: |
| Date: | Date: | Date: |
