| Acetic acid glacial USP/Ph.Eur/BP/JP PARENTEX PLUS 25L | |||
| I8010LL025 | 48060L929AZ | ||
| USP/Ph.Eur/BP/JP PARENTEX PLUS | 48060L9 | ||
| 64-19-7 | 118336 | ||
| CH3COOH | January 2026 | ||
| 60.05 | December 2028 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Appearance/Description | Clear, colorless, volatile liquid having pungent odor Boils at 117.1°C. Specific gravity is 1.049 | Crystalline mass or clear, colorless, volatile liquid having pungent odor Boils at about 118°C. Specific gravity about 1.049 | USP/Ph.Eur/BP/JP |
| 2 | Solubility | Complies | Miscible with water, with ethanol (96%), with methylene chloride, diethyl ether and with glycerin. | USP/Ph.Eur/BP/JP |
| 3 | Identification A (By Chemical test) | Complies | A 100 g/L solution is strongly acid | Ph.Eur/BP |
| 4 | Identification ( For Acetate 1) | Complies | A blue precipitate should form, or a dark blue color should develop | USP/Ph.Eur/BP |
| 5 | Identification ( For Acetate 2) | Complies | With neutral solutions of acetates, ferric chloride TS produces a red color that is destroyed by the addition of mineral acids. | USP |
| 6 | Identification A (Acetate) | Complies | The solution changes the blue litmus paper to red. | JP |
| 7 | Identification B (Acetate) | Complies | The acetates evolve the odor of acetic acid. ` | JP |
| 8 | Identification C (Acetate) | Complies | The odor Ethyl acetate should evolve. | JP |
| 9 | Identification D (Acetate) | Complies | The precipitate should dissolve and the color of the solution changes to yellow upon addition of hydrochloric acid. | JP |
| 10 | Reducing substances | Complies | The color of solution should remain pink | Ph.Eur/BP |
| 11 | Potassium permanganate- reducing substances | Complies | The red colour should not disappear within 30 minutes. | JP |
| 12 | Readily oxidizable substances | Complies | The pink color should not change to brown within 2 hours. | USP |
| 13 | Chloride (Cl) | Less than 25 mg/L | NMT 25 mg/L | Ph.Eur/BP |
| 14 | Sulphate (SO4) | Less than 50 mg/L | NMT 50 mg/L | Ph.Eur/BP |
| 15 | chloride | Complies | No opalescence should produce | USP/JP |
| 16 | Sulphate | Complies | No turbidity should produce | USP/JP |
| 17 | Iron (Fe) | Less than 5 ppm | NMT 5 ppm | Ph.Eur/BP |
| 18 | Assay | 99.62% | 99.5% to 100.5% m/m | USP/Ph.Eur/BP/JP |
| 19 | Limit of Nonvolatile residue /Residue on evaporation | 0.0024% | NMT 0.005% w/w | USP/Ph.Eur/BP/JP |
| 20 | Congealing temperature | 15.9°C | NLT 15.6°C | USP/JP |
| 21 | Freezing point | 15.2°C | Minimum 14.8 °C | Ph.Eur/BP |
| 22 | Heavy metal | Less than 10 ppm | NMT 10 ppm | JP |
| 23 | Total aerobic microbial count | Less than 100 CFU/ml | NMT 100 CFU/ml | In-house |
| 24 | Total combined yeast and molds count | Less than 100 CFU/ml | NMT 100 CFU/ml | In-house |
| 25 | E.coli | Absent/ml | should be Absent/ml | In-house |
| 26 | Pseud. aeruginosa | Absent/ml | should be Absent/ml | In-house |
| 27 | Staphylococcus aureus | Absent/ml | should be Absent/ml | In-house |
| 28 | Bile-tolerant gram negative bacteria | Absent/ml | should be Absent/ml | In-house |
| 29 | Bacterial endotoxins | Less than 0.5 EU/mg | NMT 0.5 EU/mg | In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur, BP, JP SPECIFICATION.
Actylis 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.
