| Ammonium acetate Excipient grade 500GM | |||
| 80080SG500 | 361221729JU | ||
| Excipient Grade | 3612217 | ||
| 631-61-8 | 79746 | ||
| CH3COONH4 | October 2021 | ||
| 77.08 | September 2023 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance | A hygroscopic solid. | A hygroscopic solid. |
| 2 | Aqueous solubility | Passes | Very soluble. |
| 3 | Assay | 99.22% | Min. 97.00% |
| 4 | pH(5% aq soln), at 25°C | 7.06 | 6.7 - 7.3 |
| 5 | Insoluble matter | 0.004% | 0.005% max. |
| 6 | Residue after ignition | 0.006% | 0.01% max. |
| 7 | Chloride (Cl) | Less than 5 ppm | 5 ppm max. |
| 8 | Sulphate (SO4) | Less than 0.001% | 0.001% max. |
| 9 | Iron (Fe) | Less than 5 ppm | 5 ppm max. |
| 10 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 11 | Total combined yeast and molds count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 12 | Bacterial endotoxins | Less than 2.5 EU/gm | NMT 2.5 EU/gm |
| 13 | E.coli | Absent/gm | Should be absent/gm |
| 14 | Salmonella | Absent/10 gm | Should be absent/10 gm |
| 15 | Pseudomonas aeruginosa | Absent/gm | Should be absent/gm |
| 16 | Staphylococcus aureus | Absent/gm | Should be absent/gm |
| 17 | Bile-tolerant gram negative bacteria | Absent/gm | Should be absent/gm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION.
FINAR provides this analytical report in good faith and to the best of its knowledge. It should not be substituted for the users own raw material quality control.
| Tested By (Chemist - Quality Control) | Approved By (Head - Quality Control) |
Computer Generated Report - Does not require Signature.
