{"id":16366,"date":"2025-10-21T09:02:44","date_gmt":"2025-10-21T02:02:44","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=16366"},"modified":"2025-11-15T16:07:31","modified_gmt":"2025-11-15T09:07:31","slug":"irinotecan-hydrochloride-trihydrate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/irinotecan-hydrochloride-trihydrate\/","title":{"rendered":"Irinotecan Hydrochloride Trihydrate"},"content":{"rendered":"

(Ph. Eur. monograph 2675)<\/p>\n

C_{33<\/sub>H_{39<\/sub>ClN_{4<\/sub>O_{6<\/sub>,3H_{2<\/sub>O\u00a0 \u00a0 \u00a0 677\u00a0 \u00a0 \u00a0 \u00a0136572-09-3<\/p>\n}}}}}

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

Inhibitor of DNA topoisomerase type I; antineoplastic.<\/p>\n

DEFINITION<\/h2>\n
(4S)-4,11-Diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinolin-9-yl 1,4\u2032-bipiperidine-1\u2032-carboxylate hydrochloride trihydrate.<\/p>\n
Content<\/h3>\n
98.0 per cent to 102.0 per cent (anhydrous substance).<\/p>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
Pale yellow or yellow, crystalline powder.<\/p>\n
Solubility<\/h3>\n
Sparingly soluble in water, in ethanol (96 per cent) and in methanol.<\/p>\n
It shows polymorphism (5.9).<\/p>\n
IDENTIFICATION<\/h2>\n
A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison: irinotecan hydrochloride trihydrate 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
B. Water (see Tests).<\/p>\n
C. It gives reaction (a) of chlorides (2.3.1).<\/p>\n
Dissolve 0.10 g in water R and dilute to 50 mL with the same solvent.<\/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 GY_{2<\/sub> (2.2.2, Method II).<\/p>\n}
Dissolve 0.200 g in water R with heating at 80 \u00b0C and dilute to 20 mL with the same solvent.<\/p>\n
Enantiomeric purity<\/h3>\n
Liquid chromatography (2.2.29).<\/p>\n
Solvent mixture: diethylamine R, anhydrous ethanol R (0.4:100 V\/V).<\/p>\n
Test solution: Dissolve 15.0 mg of the substance to be examined in the solvent mixture and dilute to 10.0 mL with the solvent mixture.<\/p>\n
Reference solution (a): 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
Reference solution (b): Dissolve the contents of a vial of irinotecan for system suitability 1 CRS (containing impurity L) in 1 mL of the solvent mixture.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n
\u2014 stationary phase: cellulose derivative of silica gel for chiral separation R (10 \u03bcm).<\/p>\n
Mobile phase: diethylamine R, anhydrous ethanol R, hexane R (0.2:50:50 V\/V\/V).<\/p>\n
Flow rate: 1.0 mL\/min.<\/p>\n
Detection: Spectrophotometer at 370 nm.<\/p>\n
Injection: 20 \u03bcL.<\/p>\n
Run time: 1.5 times the retention time of irinotecan.<\/p>\n
Identification of impurities: Use the chromatogram obtained with reference solution (b) to identify the peak due to impurity L.<\/p>\n
Relative retention: With reference to irinotecan (retention time = about 15 min): impurity L = about 0.7.<\/p>\n
System suitability:<\/p>\n
\u2014 resolution: minimum 1.5 between the peaks due to impurity L and irinotecan in the chromatogram obtained with reference solution (b).<\/p>\n
Calculation of percentage content:<\/p>\n
\u2014 for impurity L, use the concentration of irinotecan hydrochloride trihydrate in reference solution (a).<\/p>\n
Limit:<\/p>\n
\u2014 impurity L: maximum 0.15 per cent.<\/p>\n
Related substances<\/h3>\n
Liquid chromatography (2.2.29). Carry out the test protected from light.<\/p>\n
Solvent mixture: acetonitrile R, methanol R, mobile phase A (25:25:50 V\/V\/V).<\/p>\n
Test solution: Dissolve 50.0 mg of the substance to be examined in the solvent mixture and dilute to 50.0 mL with the solvent mixture.<\/p>\n
Reference solution (a): Dissolve 50.0 mg of irinotecan hydrochloride trihydrate CRS in the solvent mixture and dilute to 50.0 mL with 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
Reference solution (c): Dissolve the contents of a vial of irinotecan for peak identification CRS (containing impurities C and E) in 1 mL of the solvent mixture.<\/p>\n
Reference solution (d): Dissolve 5 mg of irinotecan for system suitability 2 CRS (containing impurity M) in the solvent mixture and dilute to 10 mL with the solvent mixture.<\/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 with embedded polar groups R (5 \u03bcm).<\/p>\n
Mobile phase:<\/p>\n
\u2014 mobile phase A: dissolve 2.72 g of potassium dihydrogen phosphate R in 950 mL of water for chromatography R, adjust to pH 3.5 with dilute phosphoric acid R and dilute to 1000 mL with water for chromatography R;<\/p>\n
\u2014 mobile phase B: methanol R2, acetonitrile R1 (40:60 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 – 2<\/td>\n 80<\/td>\n 20<\/td>\n<\/tr>\n
2 – 42<\/td>\n 80 \u2192 30<\/td>\n 20 \u2192 70<\/td>\n<\/tr>\n
42 – 47<\/td>\n 30<\/td>\n 70<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Flow rate: 1.0 mL\/min.<\/p>\n
Detection: Spectrophotometer at 220 nm.<\/p>\n
Injection: 10 \u03bcL of the test solution and reference solutions (b), (c) and (d).<\/p>\n
Identification of impurities: Use the chromatogram supplied with irinotecan for peak identification CRS and the chromatogram obtained with reference solution (c) to identify the peaks due to impurities C and E; use the chromatogram obtained with reference solution (d) to identify the peak due to impurity M.<\/p>\n
Relative retention: With reference to irinotecan (retention time = about 17 min): impurity M = about 0.9; impurity C = about 1.3; impurity E = about 1.5.<\/p>\n
System suitability:<\/p>\n
\u2014 resolution: minimum 2.0 between the peaks due to impurity M and irinotecan in the chromatogram obtained with reference solution (d).<\/p>\n
Calculation of percentage contents:<\/p>\n
\u2014 correction factor: multiply the peak area of impurity M by 1.3;<\/p>\n
\u2014 for each impurity, use the concentration of irinotecan hydrochloride trihydrate in reference solution (b).<\/p>\n
Limits:<\/p>\n
\u2014 impurities C, E, M: 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.<\/p>\n
Water (2.5.12)<\/h4>\n
7.0 per cent to 9.0 per cent, determined on 0.100 g.<\/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: 5 \u03bcL of the test solution and reference solution (a).<\/p>\n
Calculate the percentage content of C_{33<\/sub>H_{39<\/sub>ClN_{4<\/sub>O_{6<\/sub> taking into account the assigned content of irinotecan hydrochloride trihydrate CRS.<\/p>\n}}}}
STORAGE<\/h2>\n
In an airtight container, protected from light.<\/p>\n
IMPURITIES<\/h2>\n
Specified impurities C, E, L, M.<\/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
\nthe 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, D, F, G,
\nH, K.<\/p>\n
$\"Irinotecan$ <\/p>\n
A. (4S)-4-ethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinolin-9-yl 1,4\u2032-bipiperidine-1\u2032-carboxylate (11-desethyl irinotecan),<\/p>\n
$\"Irinotecan$ <\/p>\n
B. (4S)-4-ethyl-4,9-dihydroxy-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione (9-hydroxycamptothecin),<\/p>\n
$\"Irinotecan$ <\/p>\n
C. (4S)-4,8,11-triethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinolin-9-yl 1,4\u2032-bipiperidine-1\u2032-carboxylate (8-ethyl irinotecan),<\/p>\n
$\"Irinotecan$ <\/p>\n
D. (4S)-4-ethyl-4-hydroxy-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione (camptothecin),<\/p>\n
$\"Irinotecan$ <\/p>\n
E. (4S)-4,11-diethyl-4,9-dihydroxy-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione (11-ethyl-9-hydroxycamptothecin),<\/p>\n
$\"Irinotecan$ <\/p>\n
F. (4S)-4,11-diethyl-4-hydroxy-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione (11-ethylcamptothecin),<\/p>\n
$\"Irinotecan$ <\/p>\n
G. (4S)-4,8,11-triethyl-4,9-dihydroxy-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione (8,11-diethyl-9-hydroxycamptothecin),<\/p>\n
$\"Irinotecan$ <\/p>\n
H. (4S)-11-ethyl-4-hydroxy-4-methyl-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinolin-9-yl 1,4\u2032-bipiperidine-1\u2032-carboxylate (4-methyl irinotecan analogue),<\/p>\n
$\"Irinotecan$ <\/p>\n
K. (4S)-4-ethyl-4-hydroxy-11-(1-hydroxypropyl)-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinolin-9-yl 1,4\u2032-bipiperidine-1\u2032-carboxylate,<\/p>\n
$\"Irinotecan$ <\/p>\n
L. (4R)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinolin-9-yl 1,4\u2032-bipiperidine-1\u2032-carboxylate (irinotecan enantiomer),<\/p>\n
$\"Irinotecan$ <\/p>\n
M. (4S)-4,11-diethyl-4,12-dihydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinolin-9-yl 1,4\u2032-bipiperidine-1\u2032-carboxylate (12-hydroxy irinotecan).<\/p>\n","protected":false},"excerpt":{"rendered":"
(Ph. Eur. monograph 2675) C33H39ClN4O6,3H2O\u00a0 \u00a0 \u00a0 677\u00a0 \u00a0 \u00a0 \u00a0136572-09-3 Action and use Inhibitor of DNA topoisomerase type I; antineoplastic. DEFINITION (4S)-4,11-Diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinolin-9-yl 1,4\u2032-bipiperidine-1\u2032-carboxylate hydrochloride trihydrate. Content 98.0 per cent to 102.0 per cent (anhydrous substance). CHARACTERS Appearance Pale yellow or yellow, crystalline powder. Solubility Sparingly soluble in water, in ethanol (96 per cent) and…<\/p>\n","protected":false},"author":2,"featured_media":16620,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[188],"class_list":["post-16366","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances","tag-https-nhathuocngocanh-com-bp-wp-content-uploads-2025-10-colloidal-anhydrous-silica-british-pharmacopoeia-pdf"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16366","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=16366"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16366\/revisions"}],"predecessor-version":[{"id":16621,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16366\/revisions\/16621"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/16620"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=16366"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=16366"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=16366"}],"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 – 2<\/td>\n	80<\/td>\n	20<\/td>\n<\/tr>\n
2 – 42<\/td>\n	80 \u2192 30<\/td>\n	20 \u2192 70<\/td>\n<\/tr>\n
42 – 47<\/td>\n	30<\/td>\n	70<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Flow rate: 1.0 mL\/min.<\/p>\n Detection: Spectrophotometer at 220 nm.<\/p>\n Injection: 10 \u03bcL of the test solution and reference solutions (b), (c) and (d).<\/p>\n Identification of impurities: Use the chromatogram supplied with irinotecan for peak identification CRS and the chromatogram obtained with reference solution (c) to identify the peaks due to impurities C and E; use the chromatogram obtained with reference solution (d) to identify the peak due to impurity M.<\/p>\n Relative retention: With reference to irinotecan (retention time = about 17 min): impurity M = about 0.9; impurity C = about 1.3; impurity E = about 1.5.<\/p>\n System suitability:<\/p>\n \u2014 resolution: minimum 2.0 between the peaks due to impurity M and irinotecan in the chromatogram obtained with reference solution (d).<\/p>\n Calculation of percentage contents:<\/p>\n \u2014 correction factor: multiply the peak area of impurity M by 1.3;<\/p>\n \u2014 for each impurity, use the concentration of irinotecan hydrochloride trihydrate in reference solution (b).<\/p>\n Limits:<\/p>\n \u2014 impurities C, E, M: 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.<\/p>\n Water (2.5.12)<\/h4>\n 7.0 per cent to 9.0 per cent, determined on 0.100 g.<\/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: 5 \u03bcL of the test solution and reference solution (a).<\/p>\n Calculate the percentage content of C_{33<\/sub>H_{39<\/sub>ClN_{4<\/sub>O_{6<\/sub> taking into account the assigned content of irinotecan hydrochloride trihydrate CRS.<\/p>\n}}}} STORAGE<\/h2>\n In an airtight container, protected from light.<\/p>\n IMPURITIES<\/h2>\n Specified impurities C, E, L, M.<\/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 \nthe 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, D, F, G, \nH, K.<\/p>\n $\"Irinotecan$ <\/p>\n A. (4S)-4-ethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinolin-9-yl 1,4\u2032-bipiperidine-1\u2032-carboxylate (11-desethyl irinotecan),<\/p>\n $\"Irinotecan$ <\/p>\n B. (4S)-4-ethyl-4,9-dihydroxy-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione (9-hydroxycamptothecin),<\/p>\n $\"Irinotecan$ <\/p>\n C. (4S)-4,8,11-triethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinolin-9-yl 1,4\u2032-bipiperidine-1\u2032-carboxylate (8-ethyl irinotecan),<\/p>\n $\"Irinotecan$ <\/p>\n D. (4S)-4-ethyl-4-hydroxy-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione (camptothecin),<\/p>\n $\"Irinotecan$ <\/p>\n E. (4S)-4,11-diethyl-4,9-dihydroxy-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione (11-ethyl-9-hydroxycamptothecin),<\/p>\n $\"Irinotecan$ <\/p>\n F. (4S)-4,11-diethyl-4-hydroxy-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione (11-ethylcamptothecin),<\/p>\n $\"Irinotecan$ <\/p>\n G. (4S)-4,8,11-triethyl-4,9-dihydroxy-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione (8,11-diethyl-9-hydroxycamptothecin),<\/p>\n $\"Irinotecan$ <\/p>\n H. (4S)-11-ethyl-4-hydroxy-4-methyl-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinolin-9-yl 1,4\u2032-bipiperidine-1\u2032-carboxylate (4-methyl irinotecan analogue),<\/p>\n $\"Irinotecan$ <\/p>\n K. (4S)-4-ethyl-4-hydroxy-11-(1-hydroxypropyl)-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinolin-9-yl 1,4\u2032-bipiperidine-1\u2032-carboxylate,<\/p>\n $\"Irinotecan$ <\/p>\n L. (4R)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinolin-9-yl 1,4\u2032-bipiperidine-1\u2032-carboxylate (irinotecan enantiomer),<\/p>\n $\"Irinotecan$ <\/p>\n M. (4S)-4,11-diethyl-4,12-dihydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinolin-9-yl 1,4\u2032-bipiperidine-1\u2032-carboxylate (12-hydroxy irinotecan).<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 2675) C33H39ClN4O6,3H2O\u00a0 \u00a0 \u00a0 677\u00a0 \u00a0 \u00a0 \u00a0136572-09-3 Action and use Inhibitor of DNA topoisomerase type I; antineoplastic. DEFINITION (4S)-4,11-Diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3\u2032,4\u2032:6,7]indolizino[1,2-b]quinolin-9-yl 1,4\u2032-bipiperidine-1\u2032-carboxylate hydrochloride trihydrate. Content 98.0 per cent to 102.0 per cent (anhydrous substance). CHARACTERS Appearance Pale yellow or yellow, crystalline powder. Solubility Sparingly soluble in water, in ethanol (96 per cent) and…<\/p>\n","protected":false},"author":2,"featured_media":16620,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[188],"class_list":["post-16366","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances","tag-https-nhathuocngocanh-com-bp-wp-content-uploads-2025-10-colloidal-anhydrous-silica-british-pharmacopoeia-pdf"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16366","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=16366"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16366\/revisions"}],"predecessor-version":[{"id":16621,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16366\/revisions\/16621"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/16620"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=16366"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=16366"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=16366"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Content<\/h3>\n98.0 per cent to 102.0 per cent (anhydrous substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\nPale yellow or yellow, crystalline powder.<\/p>\n

Solubility<\/h3>\nSparingly soluble in water, in ethanol (96 per cent) 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 GY2<\/sub> (2.2.2, Method II).<\/p>\nDissolve 0.200 g in water R with heating at 80 \u00b0C and dilute to 20 mL with the same solvent.<\/p>\n

Water (2.5.12)<\/h4>\n7.0 per cent to 9.0 per cent, determined on 0.100 g.<\/p>\n

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

STORAGE<\/h2>\nIn an airtight container, protected from light.<\/p>\n

Content<\/h3>\n
98.0 per cent to 102.0 per cent (anhydrous substance).<\/p>\n

Appearance<\/h3>\n
Pale yellow or yellow, crystalline powder.<\/p>\n

Solubility<\/h3>\n
Sparingly soluble in water, in ethanol (96 per cent) 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 GY_{2<\/sub> (2.2.2, Method II).<\/p>\n}
Dissolve 0.200 g in water R with heating at 80 \u00b0C and dilute to 20 mL with the same solvent.<\/p>\n

Water (2.5.12)<\/h4>\n
7.0 per cent to 9.0 per cent, determined on 0.100 g.<\/p>\n

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

STORAGE<\/h2>\n
In an airtight container, protected from light.<\/p>\n