| Acetic acid glacial CDMF PARENTEX PLUS 2LT | |||
| I3010LC200 | 43604B421EX | ||
| CDMF PARENTEX PLUS | 43604B4 | ||
| 64-19-7 | 105199 | ||
| CH3COOH | May 2024 | ||
| 60.05 | April 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | Clear, colorless, volatile liquid having pungent odor. Boils at 118°C. Specific gravity is 1.05 | Crystalline mass or clear, colorless, volatile liquid having pungent odor. Boils at about 118°C. Specific gravity about 1.05. |
| 2 | Solubility | Complies | Miscible with water, with ethanol (96%), with methylene chloride and with glycerin. |
| 3 | Identification (Chemical test 1) | Complies | A 100 g/L solution is strongly acid. |
| 4 | Identification (Chemical test 2) | Complies | A reddish brown precipitate should form which dissolves in hydrochloric acid to form yellow solution. |
| 5 | Identification (Chemical test 3) | Complies | An odor of ethyl acetate should produce. |
| 6 | Identification (Acetates) | Complies | A blue precipitate should form or a dark blue color should develop. |
| 7 | Appearance of solution | Complies | The Substance to be examined is clear and colorless. |
| 8 | Formic acid and readily oxidizable substances | Complies | A deep yellow or brown color should produce. |
| 9 | Potassium permanganate- reducing substances | Complies | The color of solution should remain pink. |
| 10 | Readily oxidizable substances | Complies | The pink color should not change to brown within 2 hours. |
| 11 | Chloride (Cl) | Less than 0.0004% | NMT 0.0004% |
| 12 | Sulphate (SO4) | Less than 0.0005% | NMT 0.0005% |
| 13 | Iron (Fe) | Less than 5 ppm | NMT 5 ppm |
| 14 | Assay | 99.8% | 99.5% - 100.5% m/m |
| 15 | Acetaldehyde | Less than 0.01% | NMT 0.01% |
| 16 | Nonvolatile residue / Residue on evaporation | 0.0007% | The weight of the residue should not exceed 1 mg. (0.005%) |
| 17 | Congealing temperature / Freezing point | 15.7°C | NLT 15.6°C |
| 18 | Water | 0.07% | NMT 0.20% |
| 19 | Total aerobic microbial count | Less than 100 CFU/mL | NMT 100 CFU/mL |
| 20 | Total Yeast and mold count | Less than 100 CFU/mL | NMT 100 CFU/mL |
| 21 | E.coli | Absent/mL | should be Absent/mL |
| 22 | Pseud. aeruginosa | Absent/mL | should be Absent/mL |
| 23 | S.aureus | Absent/mL | should be Absent/mL |
| 24 | Bile –ve bacteria | Absent/mL | should be Absent/mL |
| 25 | Bacterial endotoxin test | Less than 0.5 EU/mg | NMT 0.5 EU/mg |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur, CP 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.
