{"id":16573,"date":"2025-10-21T08:21:57","date_gmt":"2025-10-21T01:21:57","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=16573"},"modified":"2025-10-21T08:21:57","modified_gmt":"2025-10-21T01:21:57","slug":"haloperidol-capsules","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/haloperidol-capsules\/","title":{"rendered":"Haloperidol Capsules"},"content":{"rendered":"

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

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

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

DEFINITION<\/h2>\n
Haloperidol Capsules contain Haloperidol.<\/p>\n
The capsules comply with the requirements stated under Capsules and with the following requirements.<\/p>\n
Content of haloperidol, C_{21<\/sub>H_{23<\/sub>ClFNO_{2<\/sub><\/strong><\/p>\n}}}
95.0 to 105.0% of the stated amount.<\/p>\n
IDENTIFICATION<\/h2>\n
To a quantity of the contents of the capsules containing 10 mg of Haloperidol add 10 mL of water and 1 mL of 1M sodium hydroxide and extract with 10 mL of ether. Filter the ether extract through absorbent cotton, evaporate the filtrate to dryness and dry the residue at 60\u00b0 at a pressure not exceeding 0.7 kPa. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of haloperidol (RS 173).<\/p>\n
TESTS<\/h2>\n
Dissolution<\/h3>\n
Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n
TEST CONDITIONS<\/h4>\n
(a) Use Apparatus 1, rotating the basket at 100 revolutions per minute.<\/p>\n
(b) Use 900 mL of a solution containing of 0.2% w\/v of sodium chloride and 8% v\/v of 1M hydrochloric acid in water, at a temperature of 37\u00b0, as the medium.<\/p>\n
PROCEDURE<\/h4>\n
(1) After 45 minutes withdraw a sample of the medium, filter and dilute with the dissolution medium if necessary, to produce a solution expected to contain 0.00006% w\/v of Haloperidol.<\/p>\n
(2) 0.00006% w\/v of haloperidol BPCRS in dissolution medium.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (15 cm \u00d7 5 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 \u03bcm) (Hypersil ODS is suitable).<\/p>\n
(b) Use isocratic elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 2 mL per minute.<\/p>\n
(d) Use an ambient column temperature.<\/p>\n
(e) Use a detection wavelength of 247 nm.<\/p>\n
(f) Inject 50 \u03bcL of each solution.<\/p>\n
MOBILE PHASE<\/h4>\n
45 volumes of acetonitrile and 55 volumes of a 1% w\/v solution of ammonium acetate.<\/p>\n
DETERMINATION OF CONTENT<\/h4>\n
Calculate the total content of haloperidol, C_{21<\/sub>H_{23<\/sub>ClFNO_{2<\/sub>, in the medium from the chromatograms obtained and using the declared content of C_{21<\/sub>H_{23<\/sub>ClFNO_{2 <\/sub>in haloperidol BPCRS.<\/p>\n}}}}}}
LIMITS<\/h4>\n
The amount of haloperidol released is not less than 70% (Q) of the stated amount.<\/p>\n
Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in a mixture of 1 volume of mobile phase A and 9 volumes of mobile phase B (solution A). Prepare the solutions immediately before use and protect from light.<\/p>\n
(1) Shake a quantity of the contents of the capsules containing 10 mg of Haloperidol with 15 mL of solution A and mix with the aid of ultrasound. Dilute to 20 mL and filter.<\/p>\n
(2) Dilute 1 volume of solution (1) to 200 volumes.<\/p>\n
(3) 0.05% w\/v of haloperidol for system suitability EPCRS.<\/p>\n
(4) Dilute 1 volume of solution (2) to 5 volumes.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (10 cm \u00d7 4.6 mm) packed with base-deactivated end-capped octadecylsilyl silica gel for chromatography (3 \u03bcm) (Hypersil BDS is suitable).<\/p>\n
(b) Use gradient elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1.5 mL per minute.<\/p>\n
(d) Use an ambient column temperature.<\/p>\n
(e) Use a detection wavelength of 230 nm.<\/p>\n
(f) Inject 10 \u03bcL of each solution.<\/p>\n
MOBILE PHASE<\/h4>\n
Mobile phase A 1.7% w\/v of tetrabutylammonium hydrogen sulfate.<\/p>\n
Mobile phase B acetonitrile.<\/p>\n\n\n\n\n\n\n\n\n
Time (Minutes)<\/td>\n Mobile phase A (% v\/v)<\/td>\n Mobile phase B (% v\/v)<\/td>\n Comment<\/td>\n<\/tr>\n
0-2<\/td>\n 90<\/td>\n 10<\/td>\n isocratic<\/td>\n<\/tr>\n
2-17<\/td>\n 90\u219250<\/td>\n 10\u219250<\/td>\n linear gradient<\/td>\n<\/tr>\n
17-22<\/td>\n 50<\/td>\n 50<\/td>\n isocratic<\/td>\n<\/tr>\n
22-23<\/td>\n 50\u219290<\/td>\n 50\u219210<\/td>\n linear gradient<\/td>\n<\/tr>\n
23-28<\/td>\n 90<\/td>\n 10<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
When the chromatograms are recorded under the prescribed conditions, the relative retentions with reference to haloperidol (retention time about 8 minutes) are: impurity B, about 0.9 and impurity D, about 1.6.<\/p>\n
SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and haloperidol is at least 3.0.<\/p>\n
LIMITS<\/h4>\n
Identify any peak corresponding to impurity B in the chromatogram obtained with solution (1), using the chromatogram obtained with solution (3), and multiply the area of this peak by a correction factor of 0.7.<\/p>\n
In the chromatogram obtained with solution (1):<\/p>\n
the area of any peak corresponding to impurity D is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);<\/p>\n
the area of any peak corresponding to impurity B is not greater than 0.6 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%);<\/p>\n
the area of any other secondary peak is not greater than 0.4 times the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);<\/p>\n
the sum of the areas of all secondary peaks is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (1.0%).<\/p>\n
Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.1%).<\/p>\n
Uniformity of content<\/h3>\n
Capsules containing less than 2 mg and\/or less than 2% w\/w of Haloperidol comply with the requirements stated under Capsules using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) Add sufficient of the mobile phase to the contents of one capsule to produce a solution containing 0.005% w\/v of Haloperidol, disperse with the aid of ultrasound for 2 minutes, centrifuge and use the supernatant liquid.<\/p>\n
(2) 0.005% w\/v of haloperidol BPCRS in the mobile phase.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
The chromatographic procedure described under Dissolution may be used with an injection volume of 20 \u03bcL.<\/p>\n
DETERMINATION OF CONTENT<\/h4>\n
Calculate the content of C_{21<\/sub>H_{23<\/sub>ClFNO_{2 <\/sub>in each capsule using the declared content of C_{21<\/sub>H_{23<\/sub>ClFNO_{2 <\/sub>in haloperidol BPCRS.<\/p>\n}}}}}}
ASSAY<\/h2>\n
Use the average of the individual results determined in the test for Uniformity of content.<\/p>\n
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include those listed under Haloperidol.<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Dopamine receptor antagonist; neuroleptic. DEFINITION Haloperidol Capsules contain Haloperidol. The capsules comply with the requirements stated under Capsules and with the following requirements. Content of haloperidol, C21H23ClFNO2 95.0 to 105.0% of the stated amount. IDENTIFICATION To a quantity of the contents of the capsules containing…<\/p>\n","protected":false},"author":5,"featured_media":16574,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-16573","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16573","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=16573"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16573\/revisions"}],"predecessor-version":[{"id":16577,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16573\/revisions\/16577"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/16574"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=16573"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=16573"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=16573"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time (Minutes)<\/td>\n	Mobile phase A (% v\/v)<\/td>\n	Mobile phase B (% v\/v)<\/td>\n	Comment<\/td>\n<\/tr>\n
0-2<\/td>\n	90<\/td>\n	10<\/td>\n	isocratic<\/td>\n<\/tr>\n
2-17<\/td>\n	90\u219250<\/td>\n	10\u219250<\/td>\n	linear gradient<\/td>\n<\/tr>\n
17-22<\/td>\n	50<\/td>\n	50<\/td>\n	isocratic<\/td>\n<\/tr>\n
22-23<\/td>\n	50\u219290<\/td>\n	50\u219210<\/td>\n	linear gradient<\/td>\n<\/tr>\n
23-28<\/td>\n	90<\/td>\n	10<\/td>\n	re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n When the chromatograms are recorded under the prescribed conditions, the relative retentions with reference to haloperidol (retention time about 8 minutes) are: impurity B, about 0.9 and impurity D, about 1.6.<\/p>\n SYSTEM SUITABILITY<\/h4>\n The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and haloperidol is at least 3.0.<\/p>\n LIMITS<\/h4>\n Identify any peak corresponding to impurity B in the chromatogram obtained with solution (1), using the chromatogram obtained with solution (3), and multiply the area of this peak by a correction factor of 0.7.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to impurity D is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);<\/p>\n the area of any peak corresponding to impurity B is not greater than 0.6 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%);<\/p>\n the area of any other secondary peak is not greater than 0.4 times the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);<\/p>\n the sum of the areas of all secondary peaks is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (1.0%).<\/p>\n Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.1%).<\/p>\n Uniformity of content<\/h3>\n Capsules containing less than 2 mg and\/or less than 2% w\/w of Haloperidol comply with the requirements stated under Capsules using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Add sufficient of the mobile phase to the contents of one capsule to produce a solution containing 0.005% w\/v of Haloperidol, disperse with the aid of ultrasound for 2 minutes, centrifuge and use the supernatant liquid.<\/p>\n (2) 0.005% w\/v of haloperidol BPCRS in the mobile phase.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/h4>\n The chromatographic procedure described under Dissolution may be used with an injection volume of 20 \u03bcL.<\/p>\n DETERMINATION OF CONTENT<\/h4>\n Calculate the content of C_{21<\/sub>H_{23<\/sub>ClFNO_{2 <\/sub>in each capsule using the declared content of C_{21<\/sub>H_{23<\/sub>ClFNO_{2 <\/sub>in haloperidol BPCRS.<\/p>\n}}}}}} ASSAY<\/h2>\n Use the average of the individual results determined in the test for Uniformity of content.<\/p>\n IMPURITIES<\/h2>\n The impurities limited by the requirements of this monograph include those listed under Haloperidol.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Dopamine receptor antagonist; neuroleptic. DEFINITION Haloperidol Capsules contain Haloperidol. The capsules comply with the requirements stated under Capsules and with the following requirements. Content of haloperidol, C21H23ClFNO2 95.0 to 105.0% of the stated amount. IDENTIFICATION To a quantity of the contents of the capsules containing…<\/p>\n","protected":false},"author":5,"featured_media":16574,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-16573","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16573","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=16573"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16573\/revisions"}],"predecessor-version":[{"id":16577,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16573\/revisions\/16577"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/16574"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=16573"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=16573"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=16573"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

TESTS<\/h2>\n

Dissolution<\/h3>\nComply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n

TEST CONDITIONS<\/h4>\n(a) Use Apparatus 1, rotating the basket at 100 revolutions per minute.<\/p>\n(b) Use 900 mL of a solution containing of 0.2% w\/v of sodium chloride and 8% v\/v of 1M hydrochloric acid in water, at a temperature of 37\u00b0, as the medium.<\/p>\n

PROCEDURE<\/h4>\n(1) After 45 minutes withdraw a sample of the medium, filter and dilute with the dissolution medium if necessary, to produce a solution expected to contain 0.00006% w\/v of Haloperidol.<\/p>\n(2) 0.00006% w\/v of haloperidol BPCRS in dissolution medium.<\/p>\n

MOBILE PHASE<\/h4>\n45 volumes of acetonitrile and 55 volumes of a 1% w\/v solution of ammonium acetate.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\nCalculate the total content of haloperidol, C21<\/sub>H23<\/sub>ClFNO2<\/sub>, in the medium from the chromatograms obtained and using the declared content of C21<\/sub>H23<\/sub>ClFNO2 <\/sub>in haloperidol BPCRS.<\/p>\n

LIMITS<\/h4>\nThe amount of haloperidol released is not less than 70% (Q) of the stated amount.<\/p>\n

SYSTEM SUITABILITY<\/h4>\nThe test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and haloperidol is at least 3.0.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h4>\nThe chromatographic procedure described under Dissolution may be used with an injection volume of 20 \u03bcL.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\nCalculate the content of C21<\/sub>H23<\/sub>ClFNO2 <\/sub>in each capsule using the declared content of C21<\/sub>H23<\/sub>ClFNO2 <\/sub>in haloperidol BPCRS.<\/p>\n

ASSAY<\/h2>\nUse the average of the individual results determined in the test for Uniformity of content.<\/p>\n

Dissolution<\/h3>\n
Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n

TEST CONDITIONS<\/h4>\n
(a) Use Apparatus 1, rotating the basket at 100 revolutions per minute.<\/p>\n
(b) Use 900 mL of a solution containing of 0.2% w\/v of sodium chloride and 8% v\/v of 1M hydrochloric acid in water, at a temperature of 37\u00b0, as the medium.<\/p>\n

PROCEDURE<\/h4>\n
(1) After 45 minutes withdraw a sample of the medium, filter and dilute with the dissolution medium if necessary, to produce a solution expected to contain 0.00006% w\/v of Haloperidol.<\/p>\n
(2) 0.00006% w\/v of haloperidol BPCRS in dissolution medium.<\/p>\n

MOBILE PHASE<\/h4>\n
45 volumes of acetonitrile and 55 volumes of a 1% w\/v solution of ammonium acetate.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\n
Calculate the total content of haloperidol, C_{21<\/sub>H_{23<\/sub>ClFNO_{2<\/sub>, in the medium from the chromatograms obtained and using the declared content of C_{21<\/sub>H_{23<\/sub>ClFNO_{2 <\/sub>in haloperidol BPCRS.<\/p>\n}}}}}}

LIMITS<\/h4>\n
The amount of haloperidol released is not less than 70% (Q) of the stated amount.<\/p>\n

SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and haloperidol is at least 3.0.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h4>\n
The chromatographic procedure described under Dissolution may be used with an injection volume of 20 \u03bcL.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\n
Calculate the content of C_{21<\/sub>H_{23<\/sub>ClFNO_{2 <\/sub>in each capsule using the declared content of C_{21<\/sub>H_{23<\/sub>ClFNO_{2 <\/sub>in haloperidol BPCRS.<\/p>\n}}}}}}

ASSAY<\/h2>\n
Use the average of the individual results determined in the test for Uniformity of content.<\/p>\n