| Ammonium acetate Excipient grade 5KG | |||
| 80080SR500 | 341811727BU | ||
| Excipient Grade | 3418117 | ||
| 631-61-8 | 78398 | ||
| CH3COONH4 | February 2021 | ||
| 77.08 | January 2023 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance | A hygroscopic solid. | A hygroscopic solid. |
| 2 | Aqueous solubility | Passes | Very soluble. |
| 3 | Assay | 98.82% | Min. 97.00% |
| 4 | pH(5% aq soln), at 25°C | 6.97 | 6.7 - 7.3 |
| 5 | Insoluble matter | 0.003% | 0.005% max. |
| 6 | Residue after ignition | 0.004% | 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 AS WELL AS USP/Ph-Eur 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.
