{"id":25293,"date":"2025-11-04T11:23:26","date_gmt":"2025-11-04T04:23:26","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=25293"},"modified":"2025-11-04T11:24:33","modified_gmt":"2025-11-04T04:24:33","slug":"nicotinic-acid","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/nicotinic-acid\/","title":{"rendered":"Nicotinic Acid"},"content":{"rendered":"

(Ph. Eur. monograph 0459)<\/p>\n

C_{6<\/sub>H_{5<\/sub>NO_{2\u00a0<\/sub> \u00a0 \u00a0 \u00a0 \u00a0 123.1\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 59-67-6<\/p>\n}}}

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

Component of vitamin B.<\/p>\n

Preparation<\/strong><\/p>\n

Nicotinic Acid Tablets<\/p>\n

DEFINITION<\/h2>\n
Pyridine-3-carboxylic acid.<\/p>\n
Content<\/h3>\n
99.5 per cent to 100.5 per cent (dried substance).<\/p>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
White or almost white, crystalline powder.<\/p>\n
Solubility<\/h3>\n
Sparingly soluble in water, soluble in boiling water and in boiling ethanol (96 per cent). It dissolves in dilute solutions of alkali hydroxides and carbonates.<\/p>\n
IDENTIFICATION<\/h2>\n
First identification: A, B.<\/p>\n
Second identification: A, C.<\/p>\n
A. Melting point (2.2.14): 234 \u00b0C to 240 \u00b0C.<\/p>\n
B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison: nicotinic acid CRS.<\/p>\n
C. Ultraviolet and visible absorption spectrophotometry (2.2.25).<\/p>\n
Solvent mixture: Dissolve 6.8 g of potassium dihydrogen phosphate R in 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
Test solution: Dissolve 50 mg in the solvent mixture and dilute to 100.0 mL with the solvent mixture. Dilute 1.0 mL of the solution to 25.0 mL with the solvent mixture.<\/p>\n
Spectral range: 237-262 nm.<\/p>\n
Absorption maximum: At 262 nm.<\/p>\n
Absorption minimum: At 237 nm.<\/p>\n
Absorbance ratio: A_{237<\/sub>\/A_{262<\/sub> = 0.46 to 0.50.<\/p>\n}}
TESTS<\/h2>\n
Related substances<\/h3>\n
Liquid chromatography (2.2.29).<\/p>\n
Test solution: Dissolve 0.120 g of the substance to be examined in 200 \u03bcL of dilute ammonia R1 and dilute to 10.0 mL with mobile phase A.<\/p>\n
Reference solution (a): Dilute 1.0 mL of the test solution to 100.0 mL with mobile phase A. Dilute 1.0 mL of this solution to 10.0 mL with mobile phase A.<\/p>\n
Reference solution (b): Dissolve the contents of a vial of nicotinic acid impurity mixture CRS (impurities A and B) in 1.0 mL of mobile phase A.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n
\u2014 stationary phase: end-capped octadecylsilyl silica gel for chromatography compatible with 100 per cent aqueous mobile phases R (4 \u03bcm);<\/p>\n
\u2014 temperature: 15 \u00b0C.<\/p>\n
Mobile phase:<\/p>\n
\u2014 mobile phase A: dilute 2 mL of acetic acid R in 950 mL of water for chromatography R, adjust to pH 5.6 with dilute ammonia R1 and dilute to 1000 mL with water for chromatography R;<\/p>\n
\u2014 mobile phase B: acetonitrile R, methanol R (50:50 V\/V);<\/p>\n\n\n\n\n\n\n
Time<\/strong>
\n(min)<\/strong><\/td>\n Mobile phase A<\/strong>
\n(per cent V\/V)<\/strong><\/td>\n Mobile phase B<\/strong>
\n(per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 10<\/td>\n 100<\/td>\n 0<\/td>\n<\/tr>\n
10 – 30<\/td>\n 100\u219220<\/td>\n 0\u219280<\/td>\n<\/tr>\n
30 – 35<\/td>\n 20<\/td>\n 80<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Flow rate: 1.0 mL\/min.<\/p>\n
Detection: Spectrophotometer at 250 nm.<\/p>\n
Injection: 10 \u03bcL.<\/p>\n
Identification of impurities: Use the chromatogram supplied with nicotinic acid impurity mixture CRS and the chromatogram obtained with reference solution (b) to identify the peaks due to impurities A and B.<\/p>\n
Relative retention: With reference to nicotinic acid (retention time = about 6 min): impurity A = about 2.7; impurity B = about 2.8.<\/p>\n
System suitability: Reference solution (b):<\/p>\n
\u2014 resolution: minimum 1.5 between the peaks due to impurities A and B.<\/p>\n
Limits:<\/p>\n
\u2014 unspecified impurities: for each impurity, not more than 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per cent);<\/p>\n
\u2014 total: not more than 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per cent);<\/p>\n
\u2014 disregard limit: 0.3 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.03 per cent).<\/p>\n
Chlorides (2.4.4)<\/h3>\n
Maximum 200 ppm.<\/p>\n
Dissolve 0.25 g in water R, heating on a water-bath, and dilute to 15 mL with the same solvent.<\/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 105 \u00b0C for 1 h.<\/p>\n
Sulfated ash (2.4.14)<\/h4>\n
Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n
ASSAY<\/h2>\n
Dissolve 0.250 g in 50 mL of water R. Add 0.25 mL of phenolphthalein solution R. Titrate with 0.1 M sodium hydroxide until a pink colour is obtained. Carry out a blank titration.<\/p>\n
1 mL of 0.1 M sodium hydroxide is equivalent to 12.31 mg of C_{6<\/sub>H_{5<\/sub>NO_{2<\/sub>.<\/p>\n}}}
STORAGE<\/h2>\n
Protected from light.<\/p>\n
IMPURITIES<\/h2>\n
Other detectable impurities (the following substances would, if present at a sufficient level, be detected by one or other of the tests in the monograph. They are limited by the general acceptance criterion for other\/unspecified impurities and\/or by the general monograph Substances for pharmaceutical use (2034). It is therefore not necessary to identify these impurities for demonstration of compliance. See also 5.10. Control of impurities in substances for pharmaceutical use) A, B, C, D, E, F, G, H, I.<\/p>\n
$\"Nicotinic$ <\/p>\n
A. 6-methylpyridine-3-carboxylic acid (6-methylnicotinic acid),<\/p>\n
$\"Nicotinic$ <\/p>\n
B. 2,2\u2032-bipyridine-5,5\u2032-dicarboxylic acid (6,6\u2032-dinicotinic acid),<\/p>\n
$\"Nicotinic$ <\/p>\n
C. 5-ethyl-2-methylpyridine,<\/p>\n
$\"Nicotinic$ <\/p>\n
D. pyridine-2,5-dicarboxylic acid,<\/p>\n
$\"Nicotinic$ <\/p>\n
E. pyridine-4-carboxylic acid (isonicotinic acid),<\/p>\n
$\"Nicotinic$ <\/p>\n
F. 5-nitropyridine-3-carboxylic acid (5-nitronicotinic acid),<\/p>\n
$\"Nicotinic$ <\/p>\n
G. pyridine,<\/p>\n
$\"Nicotinic$ <\/p>\n
H. 3-nitropyridine,<\/p>\n
$\"Nicotinic$ <\/p>\n
I. 3,5-dinitropyridine.<\/p>\n","protected":false},"excerpt":{"rendered":"
(Ph. Eur. monograph 0459) C6H5NO2\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 123.1\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 59-67-6 Action and use Component of vitamin B. Preparation Nicotinic Acid Tablets DEFINITION Pyridine-3-carboxylic acid. Content 99.5 per cent to 100.5 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Sparingly soluble in water, soluble in…<\/p>\n","protected":false},"author":2,"featured_media":25322,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174,1],"tags":[],"class_list":["post-25293","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances","category-volumes-1-2"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25293","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=25293"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25293\/revisions"}],"predecessor-version":[{"id":25324,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25293\/revisions\/25324"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/25322"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=25293"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=25293"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=25293"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time<\/strong> \n(min)<\/strong><\/td>\n	Mobile phase A<\/strong> \n(per cent V\/V)<\/strong><\/td>\n	Mobile phase B<\/strong> \n(per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 10<\/td>\n	100<\/td>\n	0<\/td>\n<\/tr>\n
10 – 30<\/td>\n	100\u219220<\/td>\n	0\u219280<\/td>\n<\/tr>\n
30 – 35<\/td>\n	20<\/td>\n	80<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Flow rate: 1.0 mL\/min.<\/p>\n Detection: Spectrophotometer at 250 nm.<\/p>\n Injection: 10 \u03bcL.<\/p>\n Identification of impurities: Use the chromatogram supplied with nicotinic acid impurity mixture CRS and the chromatogram obtained with reference solution (b) to identify the peaks due to impurities A and B.<\/p>\n Relative retention: With reference to nicotinic acid (retention time = about 6 min): impurity A = about 2.7; impurity B = about 2.8.<\/p>\n System suitability: Reference solution (b):<\/p>\n \u2014 resolution: minimum 1.5 between the peaks due to impurities A and B.<\/p>\n Limits:<\/p>\n \u2014 unspecified impurities: for each impurity, not more than 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per cent);<\/p>\n \u2014 total: not more than 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per cent);<\/p>\n \u2014 disregard limit: 0.3 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.03 per cent).<\/p>\n Chlorides (2.4.4)<\/h3>\n Maximum 200 ppm.<\/p>\n Dissolve 0.25 g in water R, heating on a water-bath, and dilute to 15 mL with the same solvent.<\/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 105 \u00b0C for 1 h.<\/p>\n Sulfated ash (2.4.14)<\/h4>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n ASSAY<\/h2>\n Dissolve 0.250 g in 50 mL of water R. Add 0.25 mL of phenolphthalein solution R. Titrate with 0.1 M sodium hydroxide until a pink colour is obtained. Carry out a blank titration.<\/p>\n 1 mL of 0.1 M sodium hydroxide is equivalent to 12.31 mg of C_{6<\/sub>H_{5<\/sub>NO_{2<\/sub>.<\/p>\n}}} STORAGE<\/h2>\n Protected from light.<\/p>\n IMPURITIES<\/h2>\n Other detectable impurities (the following substances would, if present at a sufficient level, be detected by one or other of the tests in the monograph. They are limited by the general acceptance criterion for other\/unspecified impurities and\/or by the general monograph Substances for pharmaceutical use (2034). It is therefore not necessary to identify these impurities for demonstration of compliance. See also 5.10. Control of impurities in substances for pharmaceutical use) A, B, C, D, E, F, G, H, I.<\/p>\n $\"Nicotinic$ <\/p>\n A. 6-methylpyridine-3-carboxylic acid (6-methylnicotinic acid),<\/p>\n $\"Nicotinic$ <\/p>\n B. 2,2\u2032-bipyridine-5,5\u2032-dicarboxylic acid (6,6\u2032-dinicotinic acid),<\/p>\n $\"Nicotinic$ <\/p>\n C. 5-ethyl-2-methylpyridine,<\/p>\n $\"Nicotinic$ <\/p>\n D. pyridine-2,5-dicarboxylic acid,<\/p>\n $\"Nicotinic$ <\/p>\n E. pyridine-4-carboxylic acid (isonicotinic acid),<\/p>\n $\"Nicotinic$ <\/p>\n F. 5-nitropyridine-3-carboxylic acid (5-nitronicotinic acid),<\/p>\n $\"Nicotinic$ <\/p>\n G. pyridine,<\/p>\n $\"Nicotinic$ <\/p>\n H. 3-nitropyridine,<\/p>\n $\"Nicotinic$ <\/p>\n I. 3,5-dinitropyridine.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 0459) C6H5NO2\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 123.1\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 59-67-6 Action and use Component of vitamin B. Preparation Nicotinic Acid Tablets DEFINITION Pyridine-3-carboxylic acid. Content 99.5 per cent to 100.5 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Sparingly soluble in water, soluble in…<\/p>\n","protected":false},"author":2,"featured_media":25322,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174,1],"tags":[],"class_list":["post-25293","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances","category-volumes-1-2"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25293","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=25293"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25293\/revisions"}],"predecessor-version":[{"id":25324,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/25293\/revisions\/25324"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/25322"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=25293"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=25293"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=25293"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Content<\/h3>\n99.5 per cent to 100.5 per cent (dried substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\nWhite or almost white, crystalline powder.<\/p>\n

Solubility<\/h3>\nSparingly soluble in water, soluble in boiling water and in boiling ethanol (96 per cent). It dissolves in dilute solutions of alkali hydroxides and carbonates.<\/p>\n

TESTS<\/h2>\n

Chlorides (2.4.4)<\/h3>\nMaximum 200 ppm.<\/p>\nDissolve 0.25 g in water R, heating on a water-bath, and dilute to 15 mL with the same solvent.<\/p>\n

Loss on drying (2.2.32)<\/h4>\nMaximum 1.0 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C for 1 h.<\/p>\n

Sulfated ash (2.4.14)<\/h4>\nMaximum 0.1 per cent, determined on 1.0 g.<\/p>\n

ASSAY<\/h2>\nDissolve 0.250 g in 50 mL of water R. Add 0.25 mL of phenolphthalein solution R. Titrate with 0.1 M sodium hydroxide until a pink colour is obtained. Carry out a blank titration.<\/p>\n1 mL of 0.1 M sodium hydroxide is equivalent to 12.31 mg of C6<\/sub>H5<\/sub>NO2<\/sub>.<\/p>\n

STORAGE<\/h2>\nProtected from light.<\/p>\n

Content<\/h3>\n
99.5 per cent to 100.5 per cent (dried substance).<\/p>\n

Appearance<\/h3>\n
White or almost white, crystalline powder.<\/p>\n

Solubility<\/h3>\n
Sparingly soluble in water, soluble in boiling water and in boiling ethanol (96 per cent). It dissolves in dilute solutions of alkali hydroxides and carbonates.<\/p>\n

Chlorides (2.4.4)<\/h3>\n
Maximum 200 ppm.<\/p>\n
Dissolve 0.25 g in water R, heating on a water-bath, and dilute to 15 mL with the same solvent.<\/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 105 \u00b0C for 1 h.<\/p>\n

Sulfated ash (2.4.14)<\/h4>\n
Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n

STORAGE<\/h2>\n
Protected from light.<\/p>\n