| Acetic acid glacial USP/Ph.Eur/BP PARENTEX PLUS 200LT | |||
| I0010LL200 | 44572B104JX | ||
| USP/Ph.Eur/BP PARENTEX PLUS | 44572B1 | ||
| 64-19-7 | 106797 | ||
| CH3COOH | October 2024 | ||
| 60.05 | September 2027 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Appearance/Description | Clear, colorless, volatile liquid having pungent odor Boils at 118°C. Specific gravity 1.05 | Crystalline mass or clear, colorless, volatile liquid having pungent odor Boils at about 118°C. Specific gravity about 1.05 | USP/Ph.Eur/BP |
| 2 | Solubility | Complies | Miscible with water, with ethanol (96%), with methylene chloride and with glycerin. | USP/Ph.Eur/BP |
| 3 | Identification A (By Chemical test) | Complies | A 100 g/L solution is strongly acid | Ph.Eur/BP |
| 4 | Identification B (Acetates) | Complies | A blue precipitate should form or a dark blue color should develop | USP/Ph.Eur/BP |
| 5 | Reducing substances | Complies | The color of solution should remain pink. | Ph.Eur/BP |
| 6 | Readily oxidizable substances | Complies | The pink color should not change to brown within 2 hours. | USP |
| 7 | Chloride (Cl) | Less than 25 mg/L | NMT 25 mg/L | Ph.Eur/BP |
| 8 | Sulphate (SO4) | Less than 50 mg/L | NMT 50 mg/L | Ph.Eur/BP |
| 9 | Iron (Fe) | Less than 5 ppm | NMT 5 ppm | Ph.Eur/BP |
| 10 | Assay | 99.9% | 99.5% to 100.5% m/m | USP/Ph.Eur/BP |
| 11 | Limit of Nonvolatile residue /Residue on evaporation | 0.0015% | NMT 0.005% w/w | USP/Ph.Eur/BP |
| 12 | Congealing temperature | 16.0°C | NLT 15.6°C | USP |
| 13 | chloride | Complies | No opalescence should produced | USP |
| 14 | Sulfate | Complies | No turbidity should produced | USP |
| 15 | Total aerobic microbial count | Less than 100 cfu/ml | NMT 100 cfu/ml | In-house |
| 16 | Total Yeast and mold count | Less than 100 cfu/ml | NMT 100 cfu/ml | In-house |
| 17 | E.coli | Absent/mL | Should be Absent/mL | In-house |
| 18 | Pseud. aeruginosa | Absent/mL | Should be Absent/mL | In-house |
| 19 | Staphylococcus aureus | Absent/mL | Should be Absent/mL | In-house |
| 20 | Bile-tolerant gram negative bacteria | Absent/mL | Should be Absent/mL | In-house |
| 21 | Bacterial endotoxin test | 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, 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.
