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Cetyl pyridinium chloride

Bulk Active : Cetyl pyridinium chloride
MOLECULAR FORMULA : C₂₁H ₃₈ ClN, H₂O
MOLECULAR WEIGHT : 358.00
Pharmacologic Activity : Antiseptic
CAS No : 123-03-5
Specifications : BP/EP/USP
Regulatory compliance : eDMF(CTD)

TEST	USP 36	BP 2013/EP 7.4

CHARACTERS	White powder, having a slight, characteristic odor.	A White or almost white powder, slightly soapy to the touch,

SOLUBILITY	Very soluble in water, in alcohol, and in chloroform; slightly soluble in benzene and in ether.	Soluble in water and in alcohol. An aqueous solution froths copiously when shaken.

IDENTIFICATION TEST A TEST B TEST C TEST D	UV absorption spectra should be concordant with Reference standard spectrum Infrared absorption spectrum of sample should be concordant with the reference spectrum of Cetyl Pyridinium Chloride reference standard. ------ Turbidity is produce rather than A curdy white ppts when the silver nitrate is added.	Examined between 240 nm and 300 nm, the solution shows absorption maximum at 259 nm and a shoulder at about 254 nm & 265 nm. The specific absorbance at the maximum is 126 to 134. Infrared absorption spectrum of sample should be concordant with the reference spectrum of Cetylpyridinium Chloride working reference standard The chloroform layer becomes blue Solution S should give test (a)for chlorides

Appearance of solution	-----	Solution S should not be more opalescent than reference Suspension II and is colourless

ACIDITY	Not more than 2.5ml of 0.02M sodium hydroxide is required for neutralization.	Not more than 2.5ml of 0.02M sodium hydroxide is required to change the colour of the indicator

Amines and amine salts	------	Potentiometric titration curve should confirm with BP specifications

Water	Between 4.5 % to 5.5 %	Between 4.5 % and 5.5 %

Melting range	Between 80°C to 84°C	---------

SULPHATED ASH	---------	NMT 0.20%

RESIDUE ON IGNITION	NMT than 0.2%	---------

HEAVY METALS	NMT 20 ppm	---------

ASSAY	NLT 99.0% and NMT 102.0% of C₂₁H₃₈ClN, calculated on the anhydrous basis.	NLT 96.0% and NMT 101.0% of C₂₁H₃₈ClN, calculated on the anhydrous basis.

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