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Butylated Hydroxytoluene CDMF 5K
83380SR50044935D222KX
CDMF44935D2
128-37-0110322
C15H24ONovember 2024
220.35October 2027
Sr.No.TestResultSpecificationMethod Reference
1DescriptionWhite crystalline solid, having a faint, characteristic odor.White, crystalline solid, having a faint, characteristic odor.USP-NF
2SolubilityCompliesFreely soluble in alcohol, in chloroform, in ether and in vegetable oils. Insoluble in water & in propylene glycol Very soluble in acetone.USP-NF/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)69.8°C69°C-70°CPh.Eur
6Identification (By UV absorbance test)84The 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)99.73%99.0%-101.5%USP-NF
10Residue on ignition /Sulfated ash0.0007%NMT 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%NMT 0.5%Ph.Eur
21Water0.04%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.
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.
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