Cetylpyridinium Chloride

Cetylpyridinium chloride is used to study the mechanisms of bacterial and virus inactivation. Generally, its monohydrate is used. A new safe & cost-effective preservative. An antiseptic used as active ingredient in over the counter, oral & personal care products. Cetylpyridinium chloride (CPC) is used in some types of mouthwashes, toothpastes, lozenges, throat sprays, breath sprays, and nasal sprays. It is an antiseptic that kills bacteria and other microorganisms. It has been shown to be effective in preventing dental plaque and reducing gingivitis. It has also been used as an ingredient in certain pesticides and for industrial purpose.

Properties and General Specifications of Cetylpyridinium Chloride monohydrate or Cetylpyridinium chloride monohydrate or Hexadecylpyridinium chloride monohydrate:
Appearance: White powder.
Assay: 99% minimum.
Water (KF): 4.5% to 5.5%
Residue on ignition (Ash): < 0.2%
Melting point: about 80C.
Solubility: Very soluble in water, chloroform.

Specifications of Cetylpyridinium Chloride USP NF Grade:
C21H38ClN-H2O --- 358.00
Pyridinium, 1-hexadecyl-, chloride, monohydrate.
1-Hexadecylpyridinium chloride monohydrate --- CAS 6004-24-6.
Anhydrous --- 339.99 [123-03-5].

Cetylpyridinium Chloride contains not less than 99.0 percent and not more than 102.0 percent of C21H38ClN, calculated on the anhydrous basis.
Packaging and storage: Preserve in well-closed containers.

Identification:
A: Infrared Absorption.
B: Ultraviolet Absorption.
C: Dissolve 100 mg in 50 mL of water: a 10-mL portion of the solution responds to the tests for Chloride, except that a turbidity is produced, rather than a curdy white precipitate, when the silver nitrate is added.
Melting range: between 80 and 84 , the preliminary drying treatment being omitted.
Acidity: Dissolve 500 mg, accurately weighed, in 50 mL of water, add phenolphthalein and titrate with 0.020 N sodium hydroxide: not more than 2.5 mL is required for neutralization.
Water: between 4.5% and 5.5%.
Residue on ignition: not more than 0.2%, calculated on the anhydrous basis.
Heavy metals: 0.002%.
Pyridine: Dissolve 1 g in 10 mL of sodium hydroxide solution (1 in 10) without heating: the odor of pyridine is not immediately perceptible.
Assay: Transfer about 200 mg of Cetylpyridinium Chloride, accurately weighed, to a glass-stoppered, 250-mL graduated cylinder containing 75 mL of water. Add 10 mL of chloroform, 0.4 mL of bromophenol blue solution (1 in 2000), and 5 mL of a freshly prepared solution of sodium bicarbonate (4.2 in 1000) and titrate with 0.02 M sodium tetraphenylboron until the blue color disappears from the chloroform layer. Add the last portions of the sodium tetraphenylboron solution dropwise, agitating vigorously after each addition. Each mL of 0.02 M sodium tetraphenylboron is equivalent to 6.800 mg of C21H38ClN.

Specifications of Cetylpyridinium Chloride BP Ph Eur Grade:

C21H38ClN-H2O --- 358.0 --- CAS 6004-24-6
Action and use: Antiseptic.

DEFINITION
Cetylpyridinium chloride contains not less than 96.0 per cent and not more than the equivalent of 101.0 per cent of 1-hexadecylpyridinium chloride, calculated with reference to the anhydrous substance.

CHARACTERS
A white or almost white powder, slightly soapy to the touch, soluble in water and in alcohol. An aqueous solution froths copiously when shaken.

IDENTIFICATION
First identification: B, D
Second identification: A, C, D
A. Dissolve 0.10 g in water and dilute to 100.0 mL with the same solvent. Dilute 5.0 mL of this solution to 100.0 mL with water. Examined between 240 nm and 300 nm, the solution shows an absorption maximum at 259 nm and 2 shoulders at about 254 nm and at about 265 nm. The specific absorbance at the maximum is 126 to 134, calculated with reference to the anhydrous substance.
B. Examine by infrared absorption spectrophotometry, comparing with the spectrum obtained with cetylpyridinium chlorideCRS. Examine the substances in the solid state.
C. To 5 mL of dilute sodium hydroxide solution add 0.1 mL of bromophenol blue solution and 5 mL of chloroform and shake. The chloroform layer is colourless. Add 0.1 mL of solution S (see Tests) and shake. The chloroform layer becomes blue.
D. Solution S gives reaction of chlorides.

TESTS
Solution S: Dissolve 1.0 g in carbon dioxide-free water and dilute to 100 mL with the same solvent.
Appearance of solution: Solution S is not more opalescent than reference suspension II and is colourless.
Acidity: To 50 mL of solution S add 0.1 mL of phenolphthalein solution. Not more than 2.5 mL of 0.02 M sodium hydroxide is required to change the colour of the indicator.
Amines and amine salts: Dissolve 5.0 g with heating in 20 mL of a mixture of 3 volumes of 1 M hydrochloric acid and 97 volumes of methanol and add 100 mL of 2-propanol. Pass a stream of nitrogen slowly through the solution. Gradually add 12.0 mL of 0.1 M tetrabutylammonium hydroxide and record the potentiometric titration curve. If the curve shows 2 points of inflexion, the volume of titrant added between the two points is not greater than 5.0 mL. If the curve shows no point of inflexion, the substance to be examined does not comply with the test. If the curve shows one point of inflexion, repeat the test but add 3.0 mL of a 25.0 g/L solution of dimethyldecylamine in 2-propanol before the titration. If the titration curve after the addition of 12.0 mL of the titrant shows only one point of inflexion, the substance to be examined does not comply with the test.
Water: 4.5 per cent to 5.5 per cent, determined on 0.300 g by the semi-micro determination of water.
Sulfated ash: Not more than 0.2 per cent, determined on 1.0 g.

ASSAY
Dissolve 2.00 g in water and dilute to 100.0 mL with the same solvent. Transfer 25.0 mL of the solution to a separating funnel, add 25 mL of chloroform, 10 mL of 0.1 M sodium hydroxide and 10.0 mL of a freshly prepared 50 g/L solution of potassium iodide. Shake well, allow to separate and discard the chloroform layer. Shake the aqueous layer with three quantities, each of 10 mL, of chloroform and discard the chloroform layers. To the aqueous layer add 40 mL of hydrochloric acid, allow to cool and titrate with 0.05 M potassium iodate until the deep brown colour is almost discharged. Add 2 mL of chloroform and continue the titration, shaking vigorously, until the chloroform layer no longer changes colour. Carry out a blank titration on a mixture of 10.0 mL of the freshly prepared 50 g/L solution of potassium iodide, 20 mL of water and 40 mL of hydrochloric acid.
1 mL of 0.05 M potassium iodate is equivalent to 34.0 mg of C21H38ClN.

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