{"id":22501,"date":"2025-10-30T11:31:23","date_gmt":"2025-10-30T04:31:23","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=22501"},"modified":"2025-10-30T11:31:23","modified_gmt":"2025-10-30T04:31:23","slug":"amprolium-hydrochloride","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/amprolium-hydrochloride\/","title":{"rendered":"Amprolium Hydrochloride"},"content":{"rendered":"

(Amprolium Hydrochloride for Veterinary use, Ph. Eur. monograph 3010)<\/p>\n

C14<\/sub>H20<\/sub>Cl2<\/sub>N4<\/sub>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0315.2\u00a0 \u00a0 \u00a0 \u00a0137-88-2<\/p>\n

Action and use<\/strong><\/p>\n

Antiprotozoal; prevention and treatment of coccidiosis (veterinary)<\/p>\n

DEFINITION<\/h2>\n

1-[(4-Amino-2-propylpyrimidin-5-yl)methyl]-2-methylpyridin-1-ium chloride hydrochloride.<\/p>\n

Content<\/h3>\n

97.5 per cent to 102.0 per cent (dried substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

White or almost white powder.<\/p>\n

Solubility<\/h3>\n

Freely soluble in water, slightly soluble in ethanol (96 per cent), practically insoluble in heptane.<\/p>\n

IDENTIFICATION<\/h2>\n

A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n

Comparison: amprolium hydrochloride CRS.<\/p>\n

B. It gives reaction (a) of chlorides (2.3.1).<\/p>\n

TESTS<\/h2>\n

Appearance of solution<\/h3>\n

The solution is clear (2.2.1) and not more intensely coloured than reference solution BY5 (2.2.2, Method II).<\/p>\n

Dissolve 0.5 g in 50 mL of water R.<\/p>\n

Related substances<\/h3>\n

Liquid chromatography (2.2.29).<\/p>\n

Solution A: Buffer solution A, mobile phase (12.5:87.5 V\/V).<\/p>\n

Buffer solution A: Dissolve 6.8 g of potassium dihydrogen phosphate R in about 900 mL of water R, adjust to pH 7.0 with dilute sodium hydroxide solution R and dilute to 1000 mL with water R.<\/p>\n

Buffer solution B: Dissolve 1.2 g of sodium hexanesulfonate R and 3.0 g of ammonium acetate R in about 900 mL of water for chromatography R, adjust to pH 3.5 with glacial acetic acid R and dilute to 1000 mL with water for chromatography R.<\/p>\n

Test solution (a): Dissolve 75.0 mg of the substance to be examined in solution A and dilute to 10.0 mL with solution A.<\/p>\n

Test solution (b): Dilute 4.0 mL of test solution (a) to 30.0 mL with solution A. Dilute 1.0 mL of this solution to 10.0 mL with solution A.<\/p>\n

Reference solution (a): Dilute 1.0 mL of test solution (a) to 10.0 mL with solution A. Dilute 1.0 mL of this solution to 50.0 mL with solution A.<\/p>\n

Reference solution (b): Dissolve 10.0 mg of amprolium hydrochloride CRS in solution A and dilute to 100.0 mL with solution A.<\/p>\n

Reference solution (c): Dissolve 12 mg of 2-methylpyridine R (impurity A) in 1 mL of test solution (a) and dilute to 100 mL with solution A.<\/p>\n

Column:<\/p>\n

\u2014 size: l = 0.15 m, \u00d8 = 4.6 mm;<\/p>\n

\u2014 stationary phase: end-capped octylsilyl silica gel for chromatography R (5 \u03bcm);<\/p>\n

\u2014 temperature: 30 \u00b0C.<\/p>\n

Mobile phase: 2-propanol R1, methanol R1, buffer solution B (5:10:85 V\/V\/V).<\/p>\n

Flow rate: 1.0 mL\/min.<\/p>\n

Detection: Spectrophotometer at 247 nm.<\/p>\n

Injection: 5 \u03bcL of test solution (a) and reference solutions (a) and (c).<\/p>\n

Run time: 3.0 times the retention time of amprolium.<\/p>\n

Identification of impurities: Use the chromatogram obtained with reference solution (c) to identify the peak due to impurity A.<\/p>\n

Relative retention: With reference to amprolium (retention time = about 8 min): impurity A = about 0.3.<\/p>\n

System suitability Reference solution (c):<\/p>\n

\u2014 resolution: minimum 10.0 between the peaks due to impurity A and amprolium.<\/p>\n

Calculation of percentage contents:<\/p>\n

\u2014 correction factor: multiply the peak area of impurity A by 1.6;<\/p>\n

\u2014 for each impurity, use the concentration of amprolium hydrochloride in reference solution (a).<\/p>\n

Limits:<\/p>\n

\u2014 impurity A: maximum 0.7 per cent;<\/p>\n

\u2014 unspecified impurities: for each impurity, maximum 0.20 per cent;<\/p>\n

\u2014 total: maximum 1.0 per cent;<\/p>\n

\u2014 reporting threshold: 0.10 per cent.<\/p>\n

Loss on drying (2.2.32)<\/h4>\n

Maximum 1.0 per cent, determined on 1.000 g by drying in an oven at 110 \u00b0C.<\/p>\n

Sulfated ash (2.4.14)<\/h4>\n

Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n

ASSAY<\/h2>\n

Liquid chromatography (2.2.29) as described in the test for related substances with the following modification.<\/p>\n

Injection Test solution (b) and reference solution (b).<\/p>\n

Calculate the percentage content of C14<\/sub>H20<\/sub>Cl2<\/sub>N4<\/sub> taking into account the assigned content of amprolium hydrochloride CRS.<\/p>\n

IMPURITIES<\/h2>\n

Specified impurities A.<\/p>\n

\"Amprolium<\/p>\n

A. 2-methylpyridine.<\/p>\n","protected":false},"excerpt":{"rendered":"

(Amprolium Hydrochloride for Veterinary use, Ph. Eur. monograph 3010) C14H20Cl2N4\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0315.2\u00a0 \u00a0 \u00a0 \u00a0137-88-2 Action and use Antiprotozoal; prevention and treatment of coccidiosis (veterinary) DEFINITION 1-[(4-Amino-2-propylpyrimidin-5-yl)methyl]-2-methylpyridin-1-ium chloride hydrochloride. Content 97.5 per cent to 102.0 per cent (dried substance). CHARACTERS Appearance White or almost white powder. Solubility Freely soluble in water, slightly…<\/p>\n","protected":false},"author":2,"featured_media":22505,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[176],"tags":[],"class_list":["post-22501","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-british-pharmacopoeia-veterinary-2020"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22501","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=22501"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22501\/revisions"}],"predecessor-version":[{"id":22507,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22501\/revisions\/22507"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22505"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22501"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22501"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22501"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}