Complaint
| Package | carton drum with two plastic bags inside |
| Net weight | 25KG/Drum |
| Storage | Sealed in cool and dry place to avoid moisture and light |
| Shelf life | 2 years when properly stored |
| Lead time | 1~3 days after confirmation |
| Test Items | Test Standard |
| Appearance | White or slightly yellowish-white hygroscopic powder |
Solubility | Very soluble to freely soluble in water,very soluble in anhydrous ethanol, practically insoluble in h eptane |
Identification | Infrared absorption spectrum is identical to that of rebeprazole sodium reference standard. |
| Loss on drying (see tests below) | |
| It gives reaction (a) of sodium | |
| PH | 9.5~11.5 |
| Loss on drying | ≤0.5% |
| Related substances (HPLC) | Impurity A ≤0.8% |
| Unspecified impurities≤0.1% | |
| Total impurities ≤1.0% | |
Residual solvents (GC) | Meth ylene Chloride ≤600ppm |
| Eth anol ≤5000ppm | |
| Isop ropyl ether≤5000ppm | |
| Ace tone≤5000ppm | |
| Assay | 97.0%~102.0% (C18H20N3NaO3S, on dried basis) |
Microbial limit | Aerobe count ≤1000CFU/g |
| Mold and yeasts count≤100CFU/g | |
| E.coli: absent for per gram |
