Compounds for Spike Recovery
| Sepharose Resin | Reason for Selection |
|---|---|
| Toluene | ICH Q3C Class 2 solvent with a 890 ppm limit |
| Epichlorohydrin | Hazardous material known to cause stomach, eye, and skin irritation; chromosome aberrations; adverse changes in blood and cancer |
| Glycidyltrimethylammonium chloride | Hazardous material known to be toxic if swallowed and a suspected carcinogen |
| Phenyl Sepharose Resin | |
| Epichlorohydrin | Hazardous material known to cause stomach, eye, and skin irritation; chromosome aberrations; adverse changes in blood and cancer |
| Ethanol | An ICH Q3C Class 3 compound with a 5000 ppm limit |
| 3-phenoxy-1,2-propanediol | The primary cleaved ligand and toxic |
| Sephacryl Resin | |
| Formaldehyde | Degradation product, toxic and carcinogenic, a hazardous substance identified in CCR, Title 8 |
| Bioprocess Bags | |
| Acetate | Major extractable, causes pH shift also an ICH Q3C Class 3 with a 5000 ppm limit |
| Formate | Major extractable, causes pH shift also an ICH Q3C Class 3 with a 5000 ppm limit |
| Phenol, 2,4-bis(1,1-dimethylethyl) | It is the primary cleaved ligand and has known toxicity |
| TC Tech Bag | |
| Caprolactam | Nylon monomer, toxic, can cause neurological symptoms |
| PVDF Filters | |
| Isopropyl alcohol | Major extractable, also an ICH Q3C Class 3 with a 5000 ppm limit |
| Acetone | Major extractable, also an ICH Q3C Class 3 with a 5000 ppm limit |
| Silicone Tubing | |
| Silicon | Major extractable from tubing |