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Butylated Hydroxytoluene CDMF 500GM
83380SG50032604D207HT
CDMF32604D2
128-37-068307
C15H24OAugust 2020
220.35July 2023
Sr.No.TestResultSpecification
1DescriptionWhite crystalline solid, having a faint, characteristic odor.White, crystalline solid, having a faint, characteristic odor. (USP-NF)
2SolubilityPassesFreely soluble in alcohol, in chloroform, in ether and in vegetable oils. Insoluble in water & in propylene glycol Very soluble in acetone. (USP/Ph.Eur)
3Identification (by IR)CompliesIR Spectra of the sample should be concomitant with IR spectra of standard. (USP-NF)
4Identification by chromatogramCompliesThe retention time of the BHT peak of the sample solution corresponds to that of the std. solution as obtained in the assay. The chromatographic profile of sample solution should exhibit only 1 major peak corresponding to the main compound.(USP-NF)
5Identification (By Freezing point)69°C69°C-70°C (Ph.Eur)
6Identification (By UV absorbance test)82.4The solution should show an absorption maximum at 278 nm & the specific absorbance at the maximum should between 80 to 90. (Ph.Eur)
7Identification by Chemical testCompliesA blue colour should develop. (Ph.Eur)
8Appearance of solutionCompliesThe solution is clear and not more intensely colored than reference solution Y5 or BY5. (Ph.Eur)
9Assay (on Anhydrous basis)99.62%99.0%-101.5% (USP-NF)
10Residue on ignition /Sulfated ash0.0004%Not more than 0.002% (USP-NF)
11Organic impurities : p-Cresol or m- cresolNot detectedNMT 0.1% (USP-NF)
12Organic impurities : 3-tert-Butyl-4Hydroxyanisole (BHA)Not detectedNMT 0.1% (USP-NF)
13Organic impurities: 3,5-Di-tert-butyl-4-hydroxybenzoic acidNot detectedNMT 0.1% (USP-NF)
14Organic impurities : 2-tert-Butyl-4-methylphenol or 2-tert-butyl-5-methylphenolNot detectedNMT 0.1% (USP-NF)
15Organic impurities : 3,5-Di-tert-butyl-4-hydroxybenzaldehydeNot detectedNMT 0.1% (USP-NF)
16Organic impurities : 4,6-Di-tert-butyl-m-cresolNot detectedNMT 0.1% (USP-NF)
17Organic impurities : 2,6-Di-tert-butyl-phenolNot detectedNMT 0.1% (USP-NF)
18Organic impurities : Any unspecified impurity0.01%NMT 0.1% (USP-NF)
19Organic impurities : total impurities0.02%NMT 0.7% (USP-NF)
20Related substances (By TLC)Less than 0.5%0.5% max. (Ph.Eur)
21Water0.042%NMT 0.1% (CP)
22ArsenicLess than 0.0001%NMT 0.0001% (CP)
23SulfateLess than 0.002%NMT 0.002% (CP)
24Free phenolLess than 0.02%NMT 0.02% (CP)
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, Ph.Eur, ChP 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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