{"id":17362,"date":"2025-10-22T10:28:47","date_gmt":"2025-10-22T03:28:47","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=17362"},"modified":"2025-10-22T10:28:47","modified_gmt":"2025-10-22T03:28:47","slug":"loratadine","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/loratadine\/","title":{"rendered":"Loratadine"},"content":{"rendered":"

(Ph. Eur. monograph 2124)<\/p>\n

C_{22<\/sub>H_{23<\/sub>ClN_{2<\/sub>O_{2<\/sub>\u00a0 \u00a0 \u00a0 \u00a0382.9\u00a0 \u00a0 \u00a0 \u00a079794-75-5<\/p>\n}}}}

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

Histamine H_{1<\/sub> receptor antagonist; antihistamine.<\/p>\n}

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

Loratadine Tablets<\/p>\n

DEFINITION<\/h2>\n
Ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine-1-carboxylate.<\/p>\n
Content<\/h3>\n
98.5 per cent to 101.5 per cent (dried substance).<\/p>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
White or almost white, crystalline powder.<\/p>\n
Solubility<\/h3>\n
Practically insoluble in water, freely soluble in acetone and in methanol.<\/p>\n
It shows polymorphism (5.9).<\/p>\n
IDENTIFICATION<\/h2>\n
Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison: loratadine CRS.<\/p>\n
If the spectra obtained in the solid state show differences, dissolve the substance to be examined and the reference substance separately in acetone R, evaporate to dryness and record new spectra using the
\nresidues.<\/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 BY_{5<\/sub> (2.2.2, Method II).<\/p>\n}
Dissolve 1.0 g in methanol R and dilute to 20.0 mL with the same solvent.<\/p>\n
Impurity H<\/h3>\n
Gas chromatography (2.2.28).<\/p>\n
Internal standard solution: Dissolve 25 mg of isoamyl benzoate R in methylene chloride R and dilute to 100 mL with the same solvent. Dilute 5.0 mL of this solution to 50 mL with methylene chloride R.<\/p>\n
Test solution: Dissolve 25.0 mg of the substance to be examined in methylene chloride R, add 1.0 mL of reference solution (a) and 1.0 mL of the internal standard solution and dilute to 5.0 mL with methylene
\nchloride R.<\/p>\n
Reference solution (a): Dissolve 25.0 mg of loratadine impurity H CRS in methylene chloride R and dilute to 100.0 mL with the same solvent. Dilute 5.0 mL of this solution to 50.0 mL with methylene chloride R.<\/p>\n
Reference solution (b): To 1.0 mL of reference solution (a) add 1.0 mL of the internal standard solution and dilute to 5.0 mL with methylene chloride R.<\/p>\n
Column:<\/p>\n
\u2014 material: fused silica;<\/p>\n
\u2014 size: l = 25 m, \u00d8 = 0.32 mm;<\/p>\n
\u2014 stationary phase: methylpolysiloxane R (film thickness 0.52 \u03bcm).<\/p>\n
Carrier gas: helium for chromatography R.<\/p>\n
Flow rate: 1.0 mL\/min.<\/p>\n
Split ratio: 1:30.<\/p>\n
Temperature:<\/p>\n\n\n\n\n\n\n\n\n
<\/td>\n Time<\/strong>
\n(min)<\/strong><\/td>\n Temperature<\/strong>
\n(\u00b0C)<\/strong><\/td>\n<\/tr>\n
Column<\/td>\n 0 – 1<\/td>\n 80<\/td>\n<\/tr>\n
<\/td>\n 1 – 23<\/td>\n 80 \u2192 300<\/td>\n<\/tr>\n
<\/td>\n 23 – 33<\/td>\n 300<\/td>\n<\/tr>\n
Injection port<\/td>\n <\/td>\n 260<\/td>\n<\/tr>\n
Detector<\/td>\n <\/td>\n 300<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Detection: Flame ionisation.<\/p>\n
Injection: 1 \u03bcL of the test solution and reference solution (b).<\/p>\n
Relative retention: With reference to loratadine (retention time = about 32 min): impurity H = about 0.33; isoamyl benzoate = about 0.37.<\/p>\n
System suitability: Reference solution (b):<\/p>\n
\u2014 resolution: minimum 2.0 between the peaks due to impurity H and isoamyl benzoate;<\/p>\n
\u2014 signal-to-noise ratio: minimum 10 for the peak due to impurity H.<\/p>\n
Limit:<\/p>\n
\u2014 impurity H: calculate the ratio (R) of the area of the peak due to impurity H to the area of the peak
\ndue to isoamyl benzoate from the chromatogram obtained with reference solution (b); from the chromatogram obtained with the test solution, calculate the ratio of the area of the peak due to impurity H to the area of the peak due to isoamyl benzoate: this ratio is not greater than twice R (0.1 per
\ncent).<\/p>\n
Related substances<\/h3>\n
Liquid chromatography (2.2.29).<\/p>\n
Test solution: Dissolve 25.0 mg of the substance to be examined in the mobile phase and dilute to 25.0 mL
\nwith the mobile phase.<\/p>\n
Reference solution (a): Dissolve 5 mg of loratadine impurity F CRS in the mobile phase and dilute to 25 mL with the mobile phase. Dilute 1 mL of this solution to 10 mL with the mobile phase.<\/p>\n
Reference solution (b): Dissolve 5 mg of loratadine for system suitability CRS (containing impurities A
\nand E) in the mobile phase, add 0.5 mL of reference solution (a) and dilute to 5 mL with the mobile phase.<\/p>\n
Reference solution (c): Dilute 1.0 mL of the test solution to 100.0 mL with the mobile phase. Dilute 1.0 mL of this solution to 10.0 mL with the mobile phase.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n
\u2014 stationary phase: spherical end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm) with very low silanol activity;<\/p>\n
\u2014 temperature: 40 \u00b0C.<\/p>\n
Mobile phase: Mix 30 volumes of methanol R, 35 volumes of a 6.8 g\/L solution of potassium dihydrogen phosphate R previously adjusted to pH 2.80 \u00b1 0.05 with phosphoric acid R and 40 volumes of acetonitrile R.<\/p>\n
Flow rate: 1.5 mL\/min.<\/p>\n
Detection: Spectrophotometer at 220 nm.<\/p>\n
Injection: 20 \u03bcL of the test solution and reference solutions (b) and (c).<\/p>\n
Run time: 5 times the retention time of loratadine.<\/p>\n
Identification of impurities: Use the chromatogram supplied with loratadine for system suitability CRS and the chromatogram obtained with reference solution (b) to identify the peaks due to impurities A and E.<\/p>\n
Relative retention: With reference to loratadine (retention time = about 12 min): impurity D = about 0.2;
\nimpurity B = about 0.4; impurity F = about 0.9; impurity E = about 1.1; impurity A = about 2.4; impurity C = about 2.7.<\/p>\n
System suitability: Reference solution (b):<\/p>\n
\u2014 peak-to-valley ratio: minimum 2.5, where H_{p<\/sub> = height above the baseline of the peak due to impurity E and H_{v<\/sub> = height above the baseline of the lowest point of the curve separating this peak from the peak due to loratadine.<\/p>\n}}
Limits:<\/p>\n
\u2014 correction factors: for the calculation of content, multiply the peak areas of the following impurities by the corresponding correction factor: impurity A = 1.7; impurity F = 1.6; impurity E = 1.9;<\/p>\n
\u2014 impurity F: not more than twice the area of the principal peak in the chromatogram obtained with
\nreference solution (c) (0.2 per cent);<\/p>\n
\u2014 impurities A, B, C, D, E: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (c) (0.1 per cent);<\/p>\n
\u2014 unspecified impurities: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (c) (0.10 per cent);<\/p>\n
\u2014 total: not more than 5 times the area of the principal peak in the chromatogram obtained with reference solution (c) (0.5 per cent);<\/p>\n
\u2014 disregard limit: 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (c) (0.05 per cent).<\/p>\n
Sulfates (2.4.13)<\/h3>\n
Maximum 150 ppm.<\/p>\n
Ignite 1.33 g at 800 \u00b1 25 \u00b0C and take up the residue with 20 mL of distilled water R. Filter, if necessary, through paper free from sulfates. Repeat the filtration with new paper filters until the filtrate is no longer
\nturbid.<\/p>\n
Loss on drying (2.2.32)<\/h4>\n
Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \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
Dissolve 0.300 g in 50 mL of glacial acetic acid R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20).<\/p>\n
1 mL of 0.1 M perchloric acid is equivalent to 38.29 mg of C_{22<\/sub>H_{23<\/sub>ClN_{2<\/sub>O_{2<\/sub>.<\/p>\n}}}}
IMPURITIES<\/h2>\n
Specified impurities A, B, C, D, E, F, H.<\/p>\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
\nother\/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.
\nControl of impurities in substances for pharmaceutical use) G.<\/p>\n
$\"Loratadine\"$ <\/p>\n
A. ethyl 4-[(11RS)-8-chloro-11-hydroxy-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]piperidine-1-carboxylate,<\/p>\n
$\"Loratadine\"$ <\/p>\n
B. 8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-one,<\/p>\n
$\"Loratadine\"$ <\/p>\n
C. ethyl 4-(4,8-dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine-1-
\ncarboxylate,<\/p>\n
$\"Loratadine\"$ <\/p>\n
D. 8-chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine,<\/p>\n
$\"Loratadine\"$ <\/p>\n
E. ethyl 4-[(11RS)-8-chloro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]-3,6-dihydropyridine-
\n1(2H)-carboxylate,<\/p>\n
$\"Loratadine\"$ <\/p>\n
F. ethyl 4-[(11RS)-8-chloro-11-fluoro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]piperidine-1-carboxylate,<\/p>\n
$\"Loratadine\"$ <\/p>\n
G. 8-chloro-11-(1-methylpiperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine,<\/p>\n
$\"Loratadine\"$ <\/p>\n
H. ethyl 4-oxopiperidine-1-carboxylate.<\/p>\n","protected":false},"excerpt":{"rendered":"
(Ph. Eur. monograph 2124) C22H23ClN2O2\u00a0 \u00a0 \u00a0 \u00a0382.9\u00a0 \u00a0 \u00a0 \u00a079794-75-5 Action and use Histamine H1 receptor antagonist; antihistamine. Preparation Loratadine Tablets DEFINITION Ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine-1-carboxylate. Content 98.5 per cent to 101.5 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Practically insoluble in water, freely soluble in acetone and in methanol….<\/p>\n","protected":false},"author":2,"featured_media":17377,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-17362","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17362","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=17362"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17362\/revisions"}],"predecessor-version":[{"id":17380,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17362\/revisions\/17380"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/17377"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=17362"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=17362"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=17362"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

<\/td>\n	Time<\/strong> \n(min)<\/strong><\/td>\n	Temperature<\/strong> \n(\u00b0C)<\/strong><\/td>\n<\/tr>\n
Column<\/td>\n	0 – 1<\/td>\n	80<\/td>\n<\/tr>\n
<\/td>\n	1 – 23<\/td>\n	80 \u2192 300<\/td>\n<\/tr>\n
<\/td>\n	23 – 33<\/td>\n	300<\/td>\n<\/tr>\n
Injection port<\/td>\n	<\/td>\n	260<\/td>\n<\/tr>\n
Detector<\/td>\n	<\/td>\n	300<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Detection: Flame ionisation.<\/p>\n Injection: 1 \u03bcL of the test solution and reference solution (b).<\/p>\n Relative retention: With reference to loratadine (retention time = about 32 min): impurity H = about 0.33; isoamyl benzoate = about 0.37.<\/p>\n System suitability: Reference solution (b):<\/p>\n \u2014 resolution: minimum 2.0 between the peaks due to impurity H and isoamyl benzoate;<\/p>\n \u2014 signal-to-noise ratio: minimum 10 for the peak due to impurity H.<\/p>\n Limit:<\/p>\n \u2014 impurity H: calculate the ratio (R) of the area of the peak due to impurity H to the area of the peak \ndue to isoamyl benzoate from the chromatogram obtained with reference solution (b); from the chromatogram obtained with the test solution, calculate the ratio of the area of the peak due to impurity H to the area of the peak due to isoamyl benzoate: this ratio is not greater than twice R (0.1 per \ncent).<\/p>\n Related substances<\/h3>\n Liquid chromatography (2.2.29).<\/p>\n Test solution: Dissolve 25.0 mg of the substance to be examined in the mobile phase and dilute to 25.0 mL \nwith the mobile phase.<\/p>\n Reference solution (a): Dissolve 5 mg of loratadine impurity F CRS in the mobile phase and dilute to 25 mL with the mobile phase. Dilute 1 mL of this solution to 10 mL with the mobile phase.<\/p>\n Reference solution (b): Dissolve 5 mg of loratadine for system suitability CRS (containing impurities A \nand E) in the mobile phase, add 0.5 mL of reference solution (a) and dilute to 5 mL with the mobile phase.<\/p>\n Reference solution (c): Dilute 1.0 mL of the test solution to 100.0 mL with the mobile phase. Dilute 1.0 mL of this solution to 10.0 mL with the mobile phase.<\/p>\n Column:<\/p>\n \u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n \u2014 stationary phase: spherical end-capped octadecylsilyl silica gel for chromatography R (5 \u03bcm) with very low silanol activity;<\/p>\n \u2014 temperature: 40 \u00b0C.<\/p>\n Mobile phase: Mix 30 volumes of methanol R, 35 volumes of a 6.8 g\/L solution of potassium dihydrogen phosphate R previously adjusted to pH 2.80 \u00b1 0.05 with phosphoric acid R and 40 volumes of acetonitrile R.<\/p>\n Flow rate: 1.5 mL\/min.<\/p>\n Detection: Spectrophotometer at 220 nm.<\/p>\n Injection: 20 \u03bcL of the test solution and reference solutions (b) and (c).<\/p>\n Run time: 5 times the retention time of loratadine.<\/p>\n Identification of impurities: Use the chromatogram supplied with loratadine for system suitability CRS and the chromatogram obtained with reference solution (b) to identify the peaks due to impurities A and E.<\/p>\n Relative retention: With reference to loratadine (retention time = about 12 min): impurity D = about 0.2; \nimpurity B = about 0.4; impurity F = about 0.9; impurity E = about 1.1; impurity A = about 2.4; impurity C = about 2.7.<\/p>\n System suitability: Reference solution (b):<\/p>\n \u2014 peak-to-valley ratio: minimum 2.5, where H_{p<\/sub> = height above the baseline of the peak due to impurity E and H_{v<\/sub> = height above the baseline of the lowest point of the curve separating this peak from the peak due to loratadine.<\/p>\n}} Limits:<\/p>\n \u2014 correction factors: for the calculation of content, multiply the peak areas of the following impurities by the corresponding correction factor: impurity A = 1.7; impurity F = 1.6; impurity E = 1.9;<\/p>\n \u2014 impurity F: not more than twice the area of the principal peak in the chromatogram obtained with \nreference solution (c) (0.2 per cent);<\/p>\n \u2014 impurities A, B, C, D, E: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (c) (0.1 per cent);<\/p>\n \u2014 unspecified impurities: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (c) (0.10 per cent);<\/p>\n \u2014 total: not more than 5 times the area of the principal peak in the chromatogram obtained with reference solution (c) (0.5 per cent);<\/p>\n \u2014 disregard limit: 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (c) (0.05 per cent).<\/p>\n Sulfates (2.4.13)<\/h3>\n Maximum 150 ppm.<\/p>\n Ignite 1.33 g at 800 \u00b1 25 \u00b0C and take up the residue with 20 mL of distilled water R. Filter, if necessary, through paper free from sulfates. Repeat the filtration with new paper filters until the filtrate is no longer \nturbid.<\/p>\n Loss on drying (2.2.32)<\/h4>\n Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \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 Dissolve 0.300 g in 50 mL of glacial acetic acid R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20).<\/p>\n 1 mL of 0.1 M perchloric acid is equivalent to 38.29 mg of C_{22<\/sub>H_{23<\/sub>ClN_{2<\/sub>O_{2<\/sub>.<\/p>\n}}}} IMPURITIES<\/h2>\n Specified impurities A, B, C, D, E, F, H.<\/p>\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 \nother\/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. \nControl of impurities in substances for pharmaceutical use) G.<\/p>\n $\"Loratadine\"$ <\/p>\n A. ethyl 4-[(11RS)-8-chloro-11-hydroxy-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]piperidine-1-carboxylate,<\/p>\n $\"Loratadine\"$ <\/p>\n B. 8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-one,<\/p>\n $\"Loratadine\"$ <\/p>\n C. ethyl 4-(4,8-dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine-1- \ncarboxylate,<\/p>\n $\"Loratadine\"$ <\/p>\n D. 8-chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine,<\/p>\n $\"Loratadine\"$ <\/p>\n E. ethyl 4-[(11RS)-8-chloro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]-3,6-dihydropyridine- \n1(2H)-carboxylate,<\/p>\n $\"Loratadine\"$ <\/p>\n F. ethyl 4-[(11RS)-8-chloro-11-fluoro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]piperidine-1-carboxylate,<\/p>\n $\"Loratadine\"$ <\/p>\n G. 8-chloro-11-(1-methylpiperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine,<\/p>\n $\"Loratadine\"$ <\/p>\n H. ethyl 4-oxopiperidine-1-carboxylate.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 2124) C22H23ClN2O2\u00a0 \u00a0 \u00a0 \u00a0382.9\u00a0 \u00a0 \u00a0 \u00a079794-75-5 Action and use Histamine H1 receptor antagonist; antihistamine. Preparation Loratadine Tablets DEFINITION Ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine-1-carboxylate. Content 98.5 per cent to 101.5 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Practically insoluble in water, freely soluble in acetone and in methanol….<\/p>\n","protected":false},"author":2,"featured_media":17377,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-17362","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17362","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=17362"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17362\/revisions"}],"predecessor-version":[{"id":17380,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17362\/revisions\/17380"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/17377"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=17362"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=17362"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=17362"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Content<\/h3>\n98.5 per cent to 101.5 per cent (dried substance).<\/p>\n

CHARACTERS<\/h2>\n

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

Solubility<\/h3>\nPractically insoluble in water, freely soluble in acetone and in methanol.<\/p>\nIt shows polymorphism (5.9).<\/p>\n

TESTS<\/h2>\n

Appearance of solution<\/h3>\nThe solution is clear (2.2.1) and not more intensely coloured than reference solution BY5<\/sub> (2.2.2, Method II).<\/p>\nDissolve 1.0 g in methanol R and dilute to 20.0 mL with the same solvent.<\/p>\n

Sulfates (2.4.13)<\/h3>\nMaximum 150 ppm.<\/p>\nIgnite 1.33 g at 800 \u00b1 25 \u00b0C and take up the residue with 20 mL of distilled water R. Filter, if necessary, through paper free from sulfates. Repeat the filtration with new paper filters until the filtrate is no longer\nturbid.<\/p>\n

Loss on drying (2.2.32)<\/h4>\nMaximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C.<\/p>\n

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

ASSAY<\/h2>\nDissolve 0.300 g in 50 mL of glacial acetic acid R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20).<\/p>\n1 mL of 0.1 M perchloric acid is equivalent to 38.29 mg of C22<\/sub>H23<\/sub>ClN2<\/sub>O2<\/sub>.<\/p>\n

Content<\/h3>\n
98.5 per cent to 101.5 per cent (dried substance).<\/p>\n

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

Solubility<\/h3>\n
Practically insoluble in water, freely soluble in acetone and in methanol.<\/p>\n
It shows polymorphism (5.9).<\/p>\n

Appearance of solution<\/h3>\n
The solution is clear (2.2.1) and not more intensely coloured than reference solution BY_{5<\/sub> (2.2.2, Method II).<\/p>\n}
Dissolve 1.0 g in methanol R and dilute to 20.0 mL with the same solvent.<\/p>\n

Sulfates (2.4.13)<\/h3>\n
Maximum 150 ppm.<\/p>\n
Ignite 1.33 g at 800 \u00b1 25 \u00b0C and take up the residue with 20 mL of distilled water R. Filter, if necessary, through paper free from sulfates. Repeat the filtration with new paper filters until the filtrate is no longer
\nturbid.<\/p>\n

Loss on drying (2.2.32)<\/h4>\n
Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 \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
Dissolve 0.300 g in 50 mL of glacial acetic acid R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20).<\/p>\n
1 mL of 0.1 M perchloric acid is equivalent to 38.29 mg of C_{22<\/sub>H_{23<\/sub>ClN_{2<\/sub>O_{2<\/sub>.<\/p>\n}}}}