{"id":22852,"date":"2025-10-30T17:15:53","date_gmt":"2025-10-30T10:15:53","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=22852"},"modified":"2025-10-30T17:15:53","modified_gmt":"2025-10-30T10:15:53","slug":"clenbuterol-injection","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/clenbuterol-injection\/","title":{"rendered":"Clenbuterol Injection"},"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 Injection is a sterile solution of Clenbuterol Hydrochloride in Water for Injections. It is supplied as a ready-to- use solution. Multi-dose containers may contain a suitable antimicrobial preservative.<\/p>\n
The injection complies with the requirements stated under Parenteral Preparations 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<\/p>\n}}}}
95.0 to 105.0% of the stated amount.<\/p>\n
IDENTIFICATION<\/h2>\n
A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<\/p>\n
Solution A 0.06% w\/v of sodium chloride, adjusted to pH 4.0 with 1M hydrochloric acid.<\/p>\n
(1) Dilute the injection with methanol, if necessary, to produce a solution containing 0.003% w\/v of Clenbuterol Hydrochloride.<\/p>\n
(2) Dilute 1 volume of a 0.06% w\/v solution of clenbuterol hydrochloride BPCRS in methanol to 20 volumes with solution A.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
(a) Use a silica gel F254 pre-coated plate (Merck silica gel 60 F254 HPTLC plates are suitable).<\/p>\n
(b) Use the mobile phase as described below.<\/p>\n
(c) Apply 5 \u00b5L of each solution.<\/p>\n
(d) Develop the plate to 6 cm.<\/p>\n
(e) After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 nm).<\/p>\n
MOBILE PHASE<\/h3>\n
0.15 volume of concentrated ammonia, 5 volumes of toluene, and 10 volumes of ethanol.<\/p>\n
CONFIRMATION<\/h3>\n
The principal spot in the chromatogram obtained with solution (1) is similar in position and size to the principal spot in the chromatogram obtained with solution (2).<\/p>\n
B. In the Assay, the principal peak in the chromatogram obtained with solution (1) has the same retention time as that in the chromatogram obtained with solution (2).<\/p>\n
TESTS<\/h2>\n
Acidity<\/h3>\n
pH, 3.5 to 5.0, Appendix V L.<\/p>\n
Clarity and colour of solution<\/h3>\n
The injection is not more opalescent than reference suspension I, Appendix IV A, and is not more intensely coloured than reference solution Y7, Appendix IV B, Method I.<\/p>\n
Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Solution A 0.06% w\/v of sodium chloride, adjusted to pH 4.0 with 1M hydrochloric acid.<\/p>\n
(1) Dilute the injection with methanol, if necessary, to produce a solution containing 0.003% w\/v of clenbuterol hydrochloride.<\/p>\n
(2) Dilute 1 volume of solution (1) to 100 volumes with methanol.<\/p>\n
(3) Dilute 1 volume of a solution containing 0.06% w\/v of clenbuterol hydrochloride BPCRS and 0.006% w\/v of clenbuterol hydrochloride impurity B EPCRS in methanol to 20 volumes with solution A.<\/p>\n
(4) Dilute 1 volume of solution (2) to 10 volumes with methanol.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (12 cm \u00d7 4.0 mm) packed with octadecylsilyl silica gel for chromatography (5 \u00b5m) (Nucleosil C18 is suitable) fitted with a pre-column (0.5 cm \u00d7 4.0 mm) packed with octadecylsilyl silica gel for chromatography (5 \u00b5m) (Nucleosil C18 is suitable).<\/p>\n
(b) Use isocratic elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1 mL per minute.<\/p>\n
(d) Use a column temperature of 40\u00b0.<\/p>\n
(e) Use a detection wavelength of 245 nm.<\/p>\n
(f) Inject 20 \u00b5L of each solution.<\/p>\n
(g) For solution (1) allow the chromatography to proceed for twice the retention time of the peak due to clenbuterol.<\/p>\n
MOBILE PHASE<\/h4>\n
167 volumes of acetonitrile, 333 volumes of methanol and 500 volumes of 0.25% w\/v citric acid monohydrate, previously adjusted to pH 4.5 with dilute ammonia solution. Dissolve sodium decanesulfonate in the resulting solution to give a concentration of 0.2% w\/v.<\/p>\n
When the chromatograms are recorded under the prescribed conditions, the relative retentions with reference to clenbuterol (retention time of about 7.4 minutes) are: impurity A, about 0.5 and impurity B, about 0.8.<\/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 clenbuterol is at least 2.0.<\/p>\n
LIMITS<\/h4>\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 all the 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 0.06% w\/v of sodium chloride, adjusted to pH 4.0 with 1M hydrochloric acid.<\/p>\n
(1) Dilute the injection with methanol, if necessary, to produce a solution containing 0.003% w\/v of clenbuterol hydrochloride.<\/p>\n
(2) 0.06% w\/v of clenbuterol hydrochloride BPCRS in methanol. Dilute 1 volume of this solution to 20 volumes with solution A.<\/p>\n
(3) Dilute 1 volume of a solution containing 0.06% w\/v of clenbuterol hydrochloride BPCRS and 0.006% w\/v of clenbuterol hydrochloride impurity B EPCRS in methanol to 20 volumes with solution A.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
The chromatographic conditions described under Related Substances may be used with an injection volume of 10 \u00b5L.<\/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 2.0.<\/p>\n
DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of C_{12<\/sub>H_{18<\/sub>Cl_{2<\/sub>N_{2<\/sub>O,HCl in the injection from the chromatograms obtained 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 Injection should be protected from light and stored at a temperature not exceeding 25\u00b0.<\/p>\n
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include impurities A and B 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 Injection is a sterile solution of Clenbuterol Hydrochloride in Water for Injections. It is supplied as a ready-to- use solution. Multi-dose containers may contain a suitable antimicrobial preservative. The injection complies with the requirements stated under Parenteral Preparations and with…<\/p>\n","protected":false},"author":5,"featured_media":22853,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[176],"tags":[],"class_list":["post-22852","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\/22852","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=22852"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22852\/revisions"}],"predecessor-version":[{"id":22862,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22852\/revisions\/22862"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22853"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22852"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22852"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22852"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

MOBILE PHASE<\/h3>\n0.15 volume of concentrated ammonia, 5 volumes of toluene, and 10 volumes of ethanol.<\/p>\n

TESTS<\/h2>\n

Acidity<\/h3>\npH, 3.5 to 5.0, Appendix V L.<\/p>\n

Clarity and colour of solution<\/h3>\nThe injection is not more opalescent than reference suspension I, Appendix IV A, and is not more intensely coloured than reference solution Y7, Appendix IV B, Method I.<\/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 clenbuterol is at least 2.0.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h3>\nThe chromatographic conditions described under Related Substances may be used with an injection volume of 10 \u00b5L.<\/p>\n

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 2.0.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\nCalculate the content of C12<\/sub>H18<\/sub>Cl2<\/sub>N2<\/sub>O,HCl in the injection from the chromatograms obtained using the declared content of C12<\/sub>H18<\/sub>Cl2<\/sub>N2<\/sub>O,HCl in clenbuterol hydrochloride BPCRS<\/p>\n

STORAGE<\/h2>\nClenbuterol Injection should be protected from light and stored at a temperature not exceeding 25\u00b0.<\/p>\n

MOBILE PHASE<\/h3>\n
0.15 volume of concentrated ammonia, 5 volumes of toluene, and 10 volumes of ethanol.<\/p>\n

Acidity<\/h3>\n
pH, 3.5 to 5.0, Appendix V L.<\/p>\n

Clarity and colour of solution<\/h3>\n
The injection is not more opalescent than reference suspension I, Appendix IV A, and is not more intensely coloured than reference solution Y7, Appendix IV B, Method I.<\/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 clenbuterol is at least 2.0.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h3>\n
The chromatographic conditions described under Related Substances may be used with an injection volume of 10 \u00b5L.<\/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 2.0.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of C_{12<\/sub>H_{18<\/sub>Cl_{2<\/sub>N_{2<\/sub>O,HCl in the injection from the chromatograms obtained 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 Injection should be protected from light and stored at a temperature not exceeding 25\u00b0.<\/p>\n