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Acetone Excipient Grade 200LT
80020LL200576501708BT
Excipient Grade5765017
67-64-161982
CH3COCH3February 2020
58.08January 2023
Sr.No.TestResultSpecification
1DescriptionTransparent, colorless, mobile, volatile liquid, having a characteristic odor. A solution (1 in 2) is neutral to litmus.Transparent, 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 colorless 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)0.7900.790 - 0.793
7Identification (By chemical test 1)CompliesAn intense red color should produce which becomes violet with the addition of 3.5 mL of acetic acid
8Identification (By chemical test 2)CompliesA greenish-blue color should produce
9Relative density, 20°C0.7900.790 to 0.793
10Assay (GC)99.90%NLT 99.0% on the anhydrous basis.
11Specific gravity,25°C0.789NMT 0.789
12Non-volatile Residue0.0005%0.004% max
13Matter insoluble in waterPassesThe solution should be clear
14Water2.1g/l3g/l max
15Reducing substancesCompliesThe 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 impurity0.001%0.05% v/v max
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.
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