{"id":22863,"date":"2025-10-30T17:22:42","date_gmt":"2025-10-30T10:22:42","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=22863"},"modified":"2025-10-30T17:22:42","modified_gmt":"2025-10-30T10:22:42","slug":"clenbuterol-oral-solution","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/clenbuterol-oral-solution\/","title":{"rendered":"Clenbuterol Oral Solution"},"content":{"rendered":"

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

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

Beta_{2<\/sub>-adrenoceptor agonist; bronchodilator.<\/p>\n}

DEFINITION<\/h2>\n
Clenbuterol Oral Solution contains Clenbuterol Hydrochloride in a suitable vehicle.<\/p>\n
The Oral Solution complies with the requirements stated under Oral Liquids and with the following requirements.<\/em><\/p>\n
Content of clenbuterol hydrochloride, C_{12<\/sub>H_{18<\/sub>Cl_{2<\/sub>N_{2<\/sub>O,HCl<\/strong><\/p>\n}}}}
95.0 to 105.0% of the stated amount.<\/p>\n
IDENTIFICATION<\/h2>\n
In the Assay, record the UV spectrum of the principal peak in the chromatograms obtained with solutions (1) and (2) with a diode array detector in the range of 200 to 400 nm:<\/p>\n
the UV spectrum of the principal peak in the chromatogram obtained with solution (1) is similar to that of the peak in the chromatogram obtained with solution (2);<\/p>\n
the retention time of the principal peak in the chromatogram obtained with solution (1) is similar to that of the peak in the chromatogram obtained with solution (2).<\/p>\n
TESTS<\/h2>\n
Related substances<\/strong><\/p>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
Solution A 2 volumes of acetonitrile, 2 volumes of methanol and 6 volumes of water.<\/p>\n
(1) To a volume of the oral solution containing 0.375 mg of Clenbuterol Hydrochloride, add 2 g of sodium chloride and shake for 15 minutes. Dilute to 25 mL with solution A, mix and filter (a 0.45-\u00b5m PTFE filter is suitable), discarding the first 3 mL of filtrate.<\/p>\n
(2) Dilute 1 volume of solution (1) to 100 volumes with solution A.<\/p>\n
(3) 0.0015% w\/v of clenbuterol hydrochloride BPCRS and 0.000015% w\/v each of clenbuterol impurity B EPCRS and clenbuterol impurity D BPCRS in solution A.<\/p>\n
(4) Dilute 1 volume of solution (2) to 10 volumes with solution A.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl amorphous organosilica polymer (5 \u00b5m) (XTerra MS C18 is suitable).<\/p>\n
(b) Use gradient elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1 mL per minute.<\/p>\n
(d) Use an ambient temperature.<\/p>\n
(e) Use a detection wavelength of 300 nm.<\/p>\n
(f) Inject 100 \u00b5L of each solution.<\/p>\n
MOBILE PHASE<\/h3>\n
Mobile phase A<\/em> 0.05M sodium hexanesulfonate in water.<\/p>\n
Mobile phase B<\/em> methanol.<\/p>\n
Mobile phase C<\/em>\u00a0 acetonitrile.<\/p>\n\n\n\n\n\n\n\n\n\n\n
Time (Minutes)<\/strong><\/td>\n Mobile phase A (% v\/v)<\/strong><\/td>\n Mobile phase B (% v\/v)<\/strong><\/td>\n Mobile phase C (% v\/v)<\/strong><\/td>\n Comment<\/strong><\/td>\n<\/tr>\n
0-10<\/td>\n 80<\/td>\n 15<\/td>\n 5<\/td>\n isocratic<\/td>\n<\/tr>\n
10-15<\/td>\n 80<\/td>\n 15\u21920<\/td>\n 5\u219220<\/td>\n linear gradient<\/td>\n<\/tr>\n
15-33<\/td>\n 80\u219250<\/td>\n 0<\/td>\n 20\u219250<\/td>\n linear gradient<\/td>\n<\/tr>\n
33-34<\/td>\n 50\u21925<\/td>\n 0<\/td>\n 50\u219295<\/td>\n linear gradient<\/td>\n<\/tr>\n
34-44<\/td>\n 5<\/td>\n 0<\/td>\n 95<\/td>\n isocratic<\/td>\n<\/tr>\n
44-45<\/td>\n 5\u219280<\/td>\n 0\u219215<\/td>\n 95\u21925<\/td>\n linear gradient<\/td>\n<\/tr>\n
45-50<\/td>\n 89<\/td>\n 15<\/td>\n 5<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
When chromatograms are recorded under the prescribed conditions, the relative retentions with reference to clenbuterol (retention time about 8 minutes) are: impurity D, about 0.3; impurity A; about 0.5 and impurity B, about 1.3.<\/p>\n
SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and clenbuterol is at least 1.5.<\/p>\n
LIMITS<\/h3>\n
Identify any peaks corresponding to impurities A, B and D in the chromatogram obtained with solution (1), using the chromatogram obtained with solution (3) and the relative retentions, and multiply the peak areas by the following correction factors: impurity D, 0.1; impurity A, 0.1 and impurity B, 0.2.<\/p>\n
In the chromatogram obtained with solution (1):<\/p>\n
the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%);<\/p>\n
the sum of the areas of any secondary peaks is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (2.5%).<\/p>\n
Disregard any peak with an area less than 3 times the area of the principal peak in the chromatogram obtained with solution (4) (0.3%).<\/p>\n
ASSAY<\/h2>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
Solution A 2 volumes of acetonitrile, 2 volumes of methanol and 6 volumes of water.<\/p>\n
(1) To a weighed quantity of the oral solution containing 0.375 mg of Clenbuterol Hydrochloride, add 2 g of sodium chloride and shake for 15 minutes. Dilute to 25 mL with solution A, mix and filter (a 0.45-\u00b5m PTFE filter is suitable), discarding the first 3 mL of filtrate.<\/p>\n
(2) 0.0015% w\/v of clenbuterol hydrochloride BPCRS in solution A.<\/p>\n
(3) 0.0015% w\/v of clenbuterol hydrochloride BPCRS and 0.000015% w\/v of clenbuterol impurity B EPCRS in solution A.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
The chromatographic conditions described under Related Substances may be used with a detection wavelength of 211 nm.<\/p>\n
SYSTEM SUITABILITY<\/h3>\n
The Assay is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and clenbuterol is at least 1.5.<\/p>\n
DETERMINATION OF CONTENT<\/h3>\n
Determine the weight per mL of the oral solution, Appendix V G, and calculate the content of C_{12<\/sub>H_{18<\/sub>Cl_{2<\/sub>N_{2<\/sub>O,HCl, weight in volume, using the declared content of C_{12<\/sub>H_{18<\/sub>Cl_{2<\/sub>N_{2<\/sub>O,HCl in clenbuterol hydrochloride BPCRS.<\/p>\n}}}}}}}}
STORAGE<\/h2>\n
Clenbuterol Oral Solution should be protected from light.<\/p>\n
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include impurities A, B and D listed under Clenbuterol Hydrochloride.<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Beta2-adrenoceptor agonist; bronchodilator. DEFINITION Clenbuterol Oral Solution contains Clenbuterol Hydrochloride in a suitable vehicle. The Oral Solution complies with the requirements stated under Oral Liquids and with the following requirements. Content of clenbuterol hydrochloride, C12H18Cl2N2O,HCl 95.0 to 105.0% of the stated amount. IDENTIFICATION In the…<\/p>\n","protected":false},"author":5,"featured_media":22864,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[176],"tags":[],"class_list":["post-22863","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-british-pharmacopoeia-veterinary-2020"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22863","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=22863"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22863\/revisions"}],"predecessor-version":[{"id":22872,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22863\/revisions\/22872"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22864"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22863"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22863"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22863"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time (Minutes)<\/strong><\/td>\n	Mobile phase A (% v\/v)<\/strong><\/td>\n	Mobile phase B (% v\/v)<\/strong><\/td>\n	Mobile phase C (% v\/v)<\/strong><\/td>\n	Comment<\/strong><\/td>\n<\/tr>\n
0-10<\/td>\n	80<\/td>\n	15<\/td>\n	5<\/td>\n	isocratic<\/td>\n<\/tr>\n
10-15<\/td>\n	80<\/td>\n	15\u21920<\/td>\n	5\u219220<\/td>\n	linear gradient<\/td>\n<\/tr>\n
15-33<\/td>\n	80\u219250<\/td>\n	0<\/td>\n	20\u219250<\/td>\n	linear gradient<\/td>\n<\/tr>\n
33-34<\/td>\n	50\u21925<\/td>\n	0<\/td>\n	50\u219295<\/td>\n	linear gradient<\/td>\n<\/tr>\n
34-44<\/td>\n	5<\/td>\n	0<\/td>\n	95<\/td>\n	isocratic<\/td>\n<\/tr>\n
44-45<\/td>\n	5\u219280<\/td>\n	0\u219215<\/td>\n	95\u21925<\/td>\n	linear gradient<\/td>\n<\/tr>\n
45-50<\/td>\n	89<\/td>\n	15<\/td>\n	5<\/td>\n	re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n When chromatograms are recorded under the prescribed conditions, the relative retentions with reference to clenbuterol (retention time about 8 minutes) are: impurity D, about 0.3; impurity A; about 0.5 and impurity B, about 1.3.<\/p>\n SYSTEM SUITABILITY<\/h3>\n The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and clenbuterol is at least 1.5.<\/p>\n LIMITS<\/h3>\n Identify any peaks corresponding to impurities A, B and D in the chromatogram obtained with solution (1), using the chromatogram obtained with solution (3) and the relative retentions, and multiply the peak areas by the following correction factors: impurity D, 0.1; impurity A, 0.1 and impurity B, 0.2.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%);<\/p>\n the sum of the areas of any secondary peaks is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (2.5%).<\/p>\n Disregard any peak with an area less than 3 times the area of the principal peak in the chromatogram obtained with solution (4) (0.3%).<\/p>\n ASSAY<\/h2>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n Solution A 2 volumes of acetonitrile, 2 volumes of methanol and 6 volumes of water.<\/p>\n (1) To a weighed quantity of the oral solution containing 0.375 mg of Clenbuterol Hydrochloride, add 2 g of sodium chloride and shake for 15 minutes. Dilute to 25 mL with solution A, mix and filter (a 0.45-\u00b5m PTFE filter is suitable), discarding the first 3 mL of filtrate.<\/p>\n (2) 0.0015% w\/v of clenbuterol hydrochloride BPCRS in solution A.<\/p>\n (3) 0.0015% w\/v of clenbuterol hydrochloride BPCRS and 0.000015% w\/v of clenbuterol impurity B EPCRS in solution A.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/h3>\n The chromatographic conditions described under Related Substances may be used with a detection wavelength of 211 nm.<\/p>\n SYSTEM SUITABILITY<\/h3>\n The Assay is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and clenbuterol is at least 1.5.<\/p>\n DETERMINATION OF CONTENT<\/h3>\n Determine the weight per mL of the oral solution, Appendix V G, and calculate the content of C_{12<\/sub>H_{18<\/sub>Cl_{2<\/sub>N_{2<\/sub>O,HCl, weight in volume, using the declared content of C_{12<\/sub>H_{18<\/sub>Cl_{2<\/sub>N_{2<\/sub>O,HCl in clenbuterol hydrochloride BPCRS.<\/p>\n}}}}}}}} STORAGE<\/h2>\n Clenbuterol Oral Solution should be protected from light.<\/p>\n IMPURITIES<\/h2>\n The impurities limited by the requirements of this monograph include impurities A, B and D listed under Clenbuterol Hydrochloride.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Beta2-adrenoceptor agonist; bronchodilator. DEFINITION Clenbuterol Oral Solution contains Clenbuterol Hydrochloride in a suitable vehicle. The Oral Solution complies with the requirements stated under Oral Liquids and with the following requirements. Content of clenbuterol hydrochloride, C12H18Cl2N2O,HCl 95.0 to 105.0% of the stated amount. IDENTIFICATION In the…<\/p>\n","protected":false},"author":5,"featured_media":22864,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[176],"tags":[],"class_list":["post-22863","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-british-pharmacopoeia-veterinary-2020"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22863","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=22863"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22863\/revisions"}],"predecessor-version":[{"id":22872,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22863\/revisions\/22872"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22864"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22863"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22863"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22863"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

SYSTEM SUITABILITY<\/h3>\nThe test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and clenbuterol is at least 1.5.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h3>\nThe chromatographic conditions described under Related Substances may be used with a detection wavelength of 211 nm.<\/p>\n

SYSTEM SUITABILITY<\/h3>\nThe Assay is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and clenbuterol is at least 1.5.<\/p>\n

STORAGE<\/h2>\nClenbuterol Oral Solution should be protected from light.<\/p>\n

SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and clenbuterol is at least 1.5.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h3>\n
The chromatographic conditions described under Related Substances may be used with a detection wavelength of 211 nm.<\/p>\n

SYSTEM SUITABILITY<\/h3>\n
The Assay is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity B and clenbuterol is at least 1.5.<\/p>\n

STORAGE<\/h2>\n
Clenbuterol Oral Solution should be protected from light.<\/p>\n