{"id":22847,"date":"2025-10-30T17:12:01","date_gmt":"2025-10-30T10:12:01","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=22847"},"modified":"2025-10-30T17:12:01","modified_gmt":"2025-10-30T10:12:01","slug":"clenbuterol-granules","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/clenbuterol-granules\/","title":{"rendered":"Clenbuterol Granules"},"content":{"rendered":"

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

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

Beta2<\/sub>-adrenoceptor agonist; bronchodilator.<\/p>\n

DEFINITION<\/h2>\n

Clenbuterol Granules contain Clenbuterol Hydrochloride.<\/p>\n

The granules comply with the requirements stated under Granules and with the following requirements.<\/em><\/p>\n

Content of clenbuterol hydrochloride, C12<\/sub>H18<\/sub>Cl2<\/sub>N2<\/sub>O,HCl<\/strong><\/p>\n

90.0 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 25 volumes of methanol R1 and 75 volumes of a solution containing 0.435% w\/v dipotassium hydrogen orthophosphate, adjusted to pH 3.0 with orthophosphoric acid.<\/p>\n

(1) Mix with the aid of ultrasound a quantity of the granules containing 0.064 mg of Clenbuterol Hydrochloride in 10 mL of solution A. Centrifuge and filter through a 0.45-\u00b5m membrane filter (Whatman RC is suitable), discarding the first 1 mL of the filtrate.<\/p>\n

(2) Dilute 1 volume of solution (1) to 100 volumes with solution A.<\/p>\n

(3) 63 ng per mL 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 (15 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 \u00b5m) (Reprosil Pur ODS-3 is suitable) fitted with a pre-column (0.5 cm \u00d7 4 mm) packed with the same material.<\/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 30\u00b0.<\/p>\n

(e) Use detection wavelengths of 211 nm and 320 nm.<\/p>\n

(f) Inject 100 \u00b5L of each solution.<\/p>\n

(g) Allow the chromatography to proceed for twice the retention time of clenbuterol.<\/p>\n

MOBILE PHASE<\/h3>\n

20 volumes of methanol R1 and 80 volumes of a solution containing 0.435% w\/v dipotassium hydrogen orthophosphate adjusted to pH 3.0 with orthophosphoric acid.<\/p>\n

When the chromatograms are recorded under the prescribed conditions, the relative retentions with reference to clenbuterol (retention time about 26 minutes) are: impurity D, about 0.4 and impurity B, about 0.6.<\/p>\n

SYSTEM SUITABILITY<\/h3>\n

The test is not valid unless, in the chromatogram obtained with solution (3) at 211 nm, the resolution between the peaks due to impurity D and impurity B is at least 8.0.<\/p>\n

LIMITS<\/h3>\n

At 320 nm<\/h4>\n

Identify any peak corresponding to impurity D 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 0.5.<\/p>\n

In the chromatogram obtained with solution (1), the area of any peak corresponding to impurity B or impurity D is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1% of each).<\/p>\n

At 211 nm<\/h4>\n

In the chromatogram obtained with solution (1):<\/p>\n

the area of any secondary peak, excluding any peaks due to impurity B or impurity D, is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%).<\/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

The total impurity content is not greater than 3.0%.<\/p>\n

ASSAY<\/h2>\n

Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n

Solution A 25 volumes of methanol R1 and 75 volumes of a solution of 0.435% w\/v dipotassium hydrogen orthophosphate, adjusted to pH 3.0 with orthophosphoric acid.<\/p>\n

(1) Mix with the aid of ultrasound a quantity of the granules containing 0.064 mg of Clenbuterol Hydrochloride in 10 mL of solution A. Centrifuge and filter through a 0.45-\u00b5m membrane filter (Whatman RC is suitable), discarding the first 1 mL of the filtrate.<\/p>\n

(2) 0.00064% w\/v of clenbuterol hydrochloride BPCRS 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

DETERMINATION OF CONTENT<\/h3>\n

Calculate the content of clenbuterol hydrochloride, C12<\/sub>H18<\/sub>Cl2<\/sub>N2<\/sub>O,HCl, in the granules from the chromatograms obtained and using the declared content of C12<\/sub>H18<\/sub>Cl2<\/sub>N2<\/sub>O,HCl in clenbuterol hydrochloride BPCRS.<\/p>\n

STORAGE<\/h2>\n

Clenbuterol Granules should be protected from light.<\/p>\n

IMPURITIES<\/h2>\n

The impurities limited by the requirements of this monograph include impurities 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 Granules contain Clenbuterol Hydrochloride. The granules comply with the requirements stated under Granules and with the following requirements. Content of clenbuterol hydrochloride, C12H18Cl2N2O,HCl 90.0 to 105.0% of the stated amount. IDENTIFICATION In the Assay, record the UV spectrum of the…<\/p>\n","protected":false},"author":5,"featured_media":22848,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[176],"tags":[],"class_list":["post-22847","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\/22847","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=22847"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22847\/revisions"}],"predecessor-version":[{"id":22851,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22847\/revisions\/22851"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22848"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22847"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22847"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22847"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}