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Acetone USP-NF/Ph.Eur/BP PARENTEX PLUS 25LT
I0020LL02536400C106LU
USP-NF/Ph.Eur/BP PARENTEX PLUS36400C1
67-64-180719
CH3COCH3December 2021
58.08November 2024
Sr.No.TestResultSpecification
1Appearance/DescriptionTransparent, colorless, mobile, volatile liquid, having a characteristic odor. A solution (1 in 2) is neutral to litmusTransparent, colorless, mobile, volatile liquid, having a characteristic odor. A solution (1 in 2) is neutral to litmus.
2SolubilityPassesMiscible with water, with alcohol, with ether with chloroform, and with most volatile oils.
3Appearance of solutionPassesClear and colourless solution
4Identification (by IR)CompliesIR Spectra of the sample should be concomitant with IR spectra of the standard
5Identification (by Chromatogram)CompliesThe retention time of the sample corresponds to that of standard obtained in the assay
6Identification (Relative density, 20°C)0.7910.790 - 0.793
7Identification (By chemical test 1)CompliesAn intense red color should produce which becomes violet with the addtion of 3.5 mL of acetic acid
8Identification (By chemical test 2)CompliesA grenish-blue color should produce
9Relative density, 20°C0.7910.790 to 0.793
10Assay (GC)99.97%NLT 99.0% on the anhydrous basis.
11Specific gravity,25°C0.788NMT 0.789
12Non-volatile Residue0.0006%0.004% max
13Matter insoluble in waterPassesThe solution should be clear
14Water2.4g/l3g/l max
15Reducing substancesPassesThe mixture should not be completely decolorised
16Acidity or AlkalinityPassesThe solution should be red or orange
17Related substances: Impurity A (Methanol)0.02%0.05% v/v max
18Related substances: Impurity B (2-Propanol)Not detected0.05% v/v max
19Related substances: Impurity C (Benzene)Not detected2 ppm v/v max
20Related substances: Any other impurity0.002%0.05% v/v max
21Total aerobic microbial countLess than 100 cfu/mlNot more than 100 cfu/ml
22Total combined yeast and mould countLess than 10 cfu/mlNot more than 10 cfu/ml
23E.coliAbsent/mlShould be absent/ml
24Staphylococcus aureusAbsent/mlShould be absent/ml
25Pseud. aeruginosaAbsent/mlShould be absent/ml
26SalmonellaAbsent/10mlShould be absent/10ml
27Bacterial endotoxinsLess than 2 EU/mlNot more than 2 EU/ml
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, Ph.Eur AND BP 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.
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