{"id":28750,"date":"2025-11-08T17:23:32","date_gmt":"2025-11-08T10:23:32","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=28750"},"modified":"2025-11-08T17:23:32","modified_gmt":"2025-11-08T10:23:32","slug":"quetiapine-fumarate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/quetiapine-fumarate\/","title":{"rendered":"Quetiapine Fumarate"},"content":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n

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

Dopamine receptor antagonist; neuroleptic.<\/p>\n

Preparations<\/strong><\/p>\n

Quetiapine Prolonged-release Tablets<\/p>\n

Quetiapine Tablets<\/p>\n

DEFINITION<\/h2>\n
Bis[2-[2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethanol] (2E)-but-2-enedioate.<\/p>\n
Content<\/strong><\/p>\n
\u2014 quetiapine fumarate (C46H54N6O8S2; Mr 883): 99.0 per cent to 101.0 per cent (dried substance);<\/p>\n
\u2014 fumaric acid (C4H4O4; Mr 116.1): 12.5 per cent to 13.8 per cent (dried substance).<\/p>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
White or almost white powder.<\/p>\n
Solubility<\/h3>\n
Slightly soluble in water, in anhydrous ethanol and in methanol.<\/p>\n
It shows polymorphism (5.9).<\/p>\n
IDENTIFICATION<\/h2>\n
Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison\u00a0 quetiapine fumarate 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 methanol R, evaporate to dryness and record new spectra using the residues.<\/p>\n
TESTS<\/h2>\n
Related substances<\/h3>\n
Liquid chromatography (2.2.29).<\/p>\n
Solvent mixture\u00a0 acetonitrile R, water R (50:50 V\/V).<\/p>\n
Test solution Dissolve 50 mg of the substance to be examined in the solvent mixture and dilute to 25.0 mL with the solvent mixture.<\/p>\n
Reference solution (a) Dissolve the contents of a vial of quetiapine for system suitability CRS (containing impurities G and N) in 1.0 mL of the solvent mixture.<\/p>\n
Reference solution (b) Dilute 1.0 mL of the test solution to 100.0 mL with the solvent mixture. Dilute 1.0 mL of this solution to 10.0 mL with the solvent mixture.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.10 m, \u00d8 = 2.1 mm;<\/p>\n
\u2014 stationary phase: end-capped, charged surface, ethylene-bridged phenylhexylsilyl silica gel for chromatography\u00a0(hybrid material) R (1.7 \u00b5m);<\/p>\n
\u2014 temperature: 50 \u00b0C.<\/p>\n
Mobile phase:<\/p>\n
\u2014 mobile phase A: mix 10 volumes of methanol R1 and 90 volumes of a 3.85 g\/L solution of ammonium acetate R, previously adjusted to pH 9.0 with ammonia R;<\/p>\n
\u2014 mobile phase B: acetonitrile for chromatography R;<\/p>\n\n\n\n\n\n\n\n\n\n
Time (min)<\/strong><\/td>\n Mobile phase A (per cent V\/V)<\/strong><\/td>\n Mobile phase B (per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 8<\/td>\n 80<\/td>\n 20<\/td>\n<\/tr>\n
8 – 14.50<\/td>\n 80 \u2192 60<\/td>\n 20 \u2192 40<\/td>\n<\/tr>\n
14.50 – 22.60<\/td>\n 60 \u2192 50<\/td>\n 40 \u2192 50<\/td>\n<\/tr>\n
22.60 – 26<\/td>\n 50 \u2192 30<\/td>\n 50 \u2192 70<\/td>\n<\/tr>\n
26 – 29<\/td>\n 30 \u2192 10<\/td>\n 70 \u2192 90<\/td>\n<\/tr>\n
29 – 30<\/td>\n 10<\/td>\n 90<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Flow rate\u00a0 0.5 mL\/min.<\/p>\n
Detection\u00a0 Spectrophotometer at 240 nm.<\/p>\n
Injection\u00a0 3.0 \u00b5L.<\/p>\n
Identification of impurities Use the chromatogram supplied with quetiapine for system suitability CRS and the chromatogram obtained with reference solution (a) to identify the peaks due to impurities G and N.<\/p>\n
Relative retention With reference to quetiapine (retention time = about 13 min): fumaric acid = about 0.05; impurity G = about 0.5; impurity N = about 1.04.<\/p>\n
System suitability:<\/p>\n
\u2014 signal-to-noise ratio: minimum 40 for the principal peak in the chromatogram obtained with reference solution (b);<\/p>\n
\u2014 peak-to-valley ratio: minimum 5.0, where Hp = height above the baseline of the peak due to impurity N and<\/p>\n
Hv = height above the baseline of the lowest point of the curve separating this peak from the peak due to quetiapine in the chromatogram obtained with reference solution (a).<\/p>\n
Calculation of percentage contents:<\/p>\n
\u2014 correction factors: multiply the peak areas of the following impurities by the corresponding correction factor: impurity G = 0.5; impurity N = 2.0;<\/p>\n
\u2014 for each impurity, use the concentration of quetiapine fumarate in reference solution (b).<\/p>\n
Limits:<\/p>\n
\u2014 impurities G, N: for each impurity, maximum 0.15 per cent;<\/p>\n
\u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n
\u2014 total: maximum 0.5 per cent;<\/p>\n
\u2014 reporting threshold: 0.05 per cent; disregard any peak due to fumaric acid.<\/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
Quetiapine fumarate<\/h3>\n
Dissolve 0.170 g in 40 mL of anhydrous 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 22.08 mg of C_{46<\/sub>H_{54<\/sub>N_{6<\/sub>O_{8<\/sub>S_{2<\/sub>.<\/p>\n}}}}}
Fumaric acid<\/h3>\n
Dissolve 0.350 g in 70 mL of a mixture of equal volumes of methanol R and water R. Titrate with 0.1 M sodium hydroxide, determining the end-point potentiometrically (2.2.20).<\/p>\n
1 mL of 0.1 M sodium hydroxide is equivalent to 5.804 mg of C_{4<\/sub>H_{4<\/sub>O_{4<\/sub>.<\/p>\n}}}
STORAGE<\/h2>\n
Protected from light.<\/p>\n
IMPURITIES<\/h2>\n
Specified impurities\u00a0 G, N.<\/em><\/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 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)\u00a0 A, B, C, D, E, F, H, I, J, K, L, O, P, Q, S, T, U, V, W.<\/em><\/p>\n
A. 2-[2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethyl acetate,<\/p>\n
B. 11-(piperazin-1-yl)dibenzo[b,f][1,4]thiazepine,<\/p>\n
C. 2-[2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethyl 2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1- yl]acetate,<\/p>\n
D. 11,11\u2032-(piperazine-1,4-diyl)bis(dibenzo[b,f][1,4]thiazepine),<\/p>\n
E. 11,11\u2032-[ethylenebis(oxyethylenepiperazine-4,1-diyl)]bis(dibenzo[b,f][1,4]thiazepine),<\/p>\n
F. [2-[(2-aminophenyl)sulfanyl]phenyl][4-[2-(2-hydroxyethoxy)ethyl]piperazin-1-yl]methanone,<\/p>\n
G. dibenzo[b,f][1,4]thiazepin-11(10H)-one,<\/p>\n
H. 2-[2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)-1-oxidopiperazin-1-yl]ethoxy]ethanol,<\/p>\n
I. 2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethanol,<\/p>\n
J. 2-[2-[2-[2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethoxy]ethoxy]ethanol,<\/p>\n
K. N-[2-[[2-[[4-[2-(2-hydroxyethoxy)ethyl]piperazin-1-yl]carbonyl]phenyl]sulfanyl]phenyl]acetamide,<\/p>\n
L. 2-[2-[4-(9-chlorodibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethanol,<\/p>\n
N. 2-[2-[4-[2-[2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethyl]piperazin-1-yl]ethoxy]ethanol,<\/p>\n
O. 11-[4-[2-[2-(triphenylmethoxy)ethoxy]ethyl]piperazin-1-yl]dibenzo[b,f][1,4]thiazepine,<\/p>\n
P. 11-(4-ethylpiperazin-1-yl)dibenzo[b,f][1,4]thiazepine,<\/p>\n
Q. 4-(dibenzo[b,f][1,4]thiazepin-11-yl)-1,1-bis[2-(2-hydroxyethoxy)ethyl]piperazin-1-ium,<\/p>\n
S. 2-[2-[4-(5-oxidodibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethanol,<\/p>\n
T. 11-(morpholin-4-yl)dibenzo[b,f][1,4]thiazepine,<\/p>\n
U. dibenzo[b,f][1,4]thiazepin-11-amine,<\/p>\n
V. 2-[2-[4-(phenanthridin-6-yl)piperazin-1-yl]ethoxy]ethanol,<\/p>\n
W. 11-(4-[2-[2-(dibenzo[b,f][1,4]thiazepin-11-yloxy)ethoxy]ethyl]piperazin-1-yl)dibenzo[b,f][1,4]thiazepine.<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Dopamine receptor antagonist; neuroleptic. Preparations Quetiapine Prolonged-release Tablets Quetiapine Tablets DEFINITION Bis[2-[2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethanol] (2E)-but-2-enedioate. Content \u2014 quetiapine fumarate (C46H54N6O8S2; Mr 883): 99.0 per cent to 101.0 per cent (dried substance); \u2014 fumaric acid (C4H4O4; Mr 116.1): 12.5 per cent to 13.8 per cent (dried substance). CHARACTERS…<\/p>\n","protected":false},"author":5,"featured_media":28753,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-28750","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\/28750","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\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=28750"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/28750\/revisions"}],"predecessor-version":[{"id":28761,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/28750\/revisions\/28761"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/28753"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=28750"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=28750"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=28750"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time (min)<\/strong><\/td>\n	Mobile phase A (per cent V\/V)<\/strong><\/td>\n	Mobile phase B (per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 8<\/td>\n	80<\/td>\n	20<\/td>\n<\/tr>\n
8 – 14.50<\/td>\n	80 \u2192 60<\/td>\n	20 \u2192 40<\/td>\n<\/tr>\n
14.50 – 22.60<\/td>\n	60 \u2192 50<\/td>\n	40 \u2192 50<\/td>\n<\/tr>\n
22.60 – 26<\/td>\n	50 \u2192 30<\/td>\n	50 \u2192 70<\/td>\n<\/tr>\n
26 – 29<\/td>\n	30 \u2192 10<\/td>\n	70 \u2192 90<\/td>\n<\/tr>\n
29 – 30<\/td>\n	10<\/td>\n	90<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Flow rate\u00a0 0.5 mL\/min.<\/p>\n Detection\u00a0 Spectrophotometer at 240 nm.<\/p>\n Injection\u00a0 3.0 \u00b5L.<\/p>\n Identification of impurities Use the chromatogram supplied with quetiapine for system suitability CRS and the chromatogram obtained with reference solution (a) to identify the peaks due to impurities G and N.<\/p>\n Relative retention With reference to quetiapine (retention time = about 13 min): fumaric acid = about 0.05; impurity G = about 0.5; impurity N = about 1.04.<\/p>\n System suitability:<\/p>\n \u2014 signal-to-noise ratio: minimum 40 for the principal peak in the chromatogram obtained with reference solution (b);<\/p>\n \u2014 peak-to-valley ratio: minimum 5.0, where Hp = height above the baseline of the peak due to impurity N and<\/p>\n Hv = height above the baseline of the lowest point of the curve separating this peak from the peak due to quetiapine in the chromatogram obtained with reference solution (a).<\/p>\n Calculation of percentage contents:<\/p>\n \u2014 correction factors: multiply the peak areas of the following impurities by the corresponding correction factor: impurity G = 0.5; impurity N = 2.0;<\/p>\n \u2014 for each impurity, use the concentration of quetiapine fumarate in reference solution (b).<\/p>\n Limits:<\/p>\n \u2014 impurities G, N: for each impurity, maximum 0.15 per cent;<\/p>\n \u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n \u2014 total: maximum 0.5 per cent;<\/p>\n \u2014 reporting threshold: 0.05 per cent; disregard any peak due to fumaric acid.<\/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 Quetiapine fumarate<\/h3>\n Dissolve 0.170 g in 40 mL of anhydrous 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 22.08 mg of C_{46<\/sub>H_{54<\/sub>N_{6<\/sub>O_{8<\/sub>S_{2<\/sub>.<\/p>\n}}}}} Fumaric acid<\/h3>\n Dissolve 0.350 g in 70 mL of a mixture of equal volumes of methanol R and water R. Titrate with 0.1 M sodium hydroxide, determining the end-point potentiometrically (2.2.20).<\/p>\n 1 mL of 0.1 M sodium hydroxide is equivalent to 5.804 mg of C_{4<\/sub>H_{4<\/sub>O_{4<\/sub>.<\/p>\n}}} STORAGE<\/h2>\n Protected from light.<\/p>\n IMPURITIES<\/h2>\n Specified impurities\u00a0 G, N.<\/em><\/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 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)\u00a0 A, B, C, D, E, F, H, I, J, K, L, O, P, Q, S, T, U, V, W.<\/em><\/p>\n A. 2-[2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethyl acetate,<\/p>\n B. 11-(piperazin-1-yl)dibenzo[b,f][1,4]thiazepine,<\/p>\n C. 2-[2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethyl 2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1- yl]acetate,<\/p>\n D. 11,11\u2032-(piperazine-1,4-diyl)bis(dibenzo[b,f][1,4]thiazepine),<\/p>\n E. 11,11\u2032-[ethylenebis(oxyethylenepiperazine-4,1-diyl)]bis(dibenzo[b,f][1,4]thiazepine),<\/p>\n F. [2-[(2-aminophenyl)sulfanyl]phenyl][4-[2-(2-hydroxyethoxy)ethyl]piperazin-1-yl]methanone,<\/p>\n G. dibenzo[b,f][1,4]thiazepin-11(10H)-one,<\/p>\n H. 2-[2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)-1-oxidopiperazin-1-yl]ethoxy]ethanol,<\/p>\n I. 2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethanol,<\/p>\n J. 2-[2-[2-[2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethoxy]ethoxy]ethanol,<\/p>\n K. N-[2-[[2-[[4-[2-(2-hydroxyethoxy)ethyl]piperazin-1-yl]carbonyl]phenyl]sulfanyl]phenyl]acetamide,<\/p>\n L. 2-[2-[4-(9-chlorodibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethanol,<\/p>\n N. 2-[2-[4-[2-[2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethyl]piperazin-1-yl]ethoxy]ethanol,<\/p>\n O. 11-[4-[2-[2-(triphenylmethoxy)ethoxy]ethyl]piperazin-1-yl]dibenzo[b,f][1,4]thiazepine,<\/p>\n P. 11-(4-ethylpiperazin-1-yl)dibenzo[b,f][1,4]thiazepine,<\/p>\n Q. 4-(dibenzo[b,f][1,4]thiazepin-11-yl)-1,1-bis[2-(2-hydroxyethoxy)ethyl]piperazin-1-ium,<\/p>\n S. 2-[2-[4-(5-oxidodibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethanol,<\/p>\n T. 11-(morpholin-4-yl)dibenzo[b,f][1,4]thiazepine,<\/p>\n U. dibenzo[b,f][1,4]thiazepin-11-amine,<\/p>\n V. 2-[2-[4-(phenanthridin-6-yl)piperazin-1-yl]ethoxy]ethanol,<\/p>\n W. 11-(4-[2-[2-(dibenzo[b,f][1,4]thiazepin-11-yloxy)ethoxy]ethyl]piperazin-1-yl)dibenzo[b,f][1,4]thiazepine.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Dopamine receptor antagonist; neuroleptic. Preparations Quetiapine Prolonged-release Tablets Quetiapine Tablets DEFINITION Bis[2-[2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethanol] (2E)-but-2-enedioate. Content \u2014 quetiapine fumarate (C46H54N6O8S2; Mr 883): 99.0 per cent to 101.0 per cent (dried substance); \u2014 fumaric acid (C4H4O4; Mr 116.1): 12.5 per cent to 13.8 per cent (dried substance). CHARACTERS…<\/p>\n","protected":false},"author":5,"featured_media":28753,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-28750","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\/28750","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\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=28750"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/28750\/revisions"}],"predecessor-version":[{"id":28761,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/28750\/revisions\/28761"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/28753"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=28750"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=28750"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=28750"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

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

Solubility<\/h3>\nSlightly soluble in water, in anhydrous ethanol and in methanol.<\/p>\nIt shows polymorphism (5.9).<\/p>\n

TESTS<\/h2>\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>\n

Quetiapine fumarate<\/h3>\nDissolve 0.170 g in 40 mL of anhydrous 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 22.08 mg of C46<\/sub>H54<\/sub>N6<\/sub>O8<\/sub>S2<\/sub>.<\/p>\n

Fumaric acid<\/h3>\nDissolve 0.350 g in 70 mL of a mixture of equal volumes of methanol R and water R. Titrate with 0.1 M sodium hydroxide, determining the end-point potentiometrically (2.2.20).<\/p>\n1 mL of 0.1 M sodium hydroxide is equivalent to 5.804 mg of C4<\/sub>H4<\/sub>O4<\/sub>.<\/p>\n

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

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

Solubility<\/h3>\n
Slightly soluble in water, in anhydrous ethanol and in methanol.<\/p>\n
It shows polymorphism (5.9).<\/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

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