{"id":24709,"date":"2025-11-03T15:13:32","date_gmt":"2025-11-03T08:13:32","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=24709"},"modified":"2025-11-03T15:13:32","modified_gmt":"2025-11-03T08:13:32","slug":"oxytetracycline-cutaneous-spray","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/oxytetracycline-cutaneous-spray\/","title":{"rendered":"Oxytetracycline Cutaneous Spray"},"content":{"rendered":"

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

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

Tetracycline antibacterial.<\/p>\n

DEFINITION<\/h2>\n
Oxytetracycline Cutaneous Spray contains Oxytetracycline Hydrochloride in a suitable vehicle.<\/p>\n
The cutaneous spray complies with the requirements stated under Veterinary Liquid Preparations for Cutaneous Application and with the following requirements.<\/em><\/p>\n
Content of oxytetracycline hydrochloride, C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{9<\/sub>,HCl<\/strong><\/p>\n}}}}
90.0 to 110.0% 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 210 to 400 nm:<\/p>\n
the UV spectrum of the principal peak in the chromatogram obtained with solution (1) is concordant 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 in a mixture of 20 volumes of acetonitrile and 80 volumes of 0.01M oxalic acid (solvent A). Prepare the solutions immediately before use.<\/p>\n
(1) Shake a quantity of the cutaneous spray containing 0.16 g of Oxytetracycline Hydrochloride in 150 mL of solvent A and dilute to 200 mL. Filter the resulting solution (Whatman GF\/C filter is suitable).<\/p>\n
(2) Dilute 1 volume of solution (1) to 100 volumes.<\/p>\n
(3) 0.08% w\/v of oxytetracycline for system suitability A EPCRS.<\/p>\n
(4) 0.0008% w\/v of sulfan blue.<\/p>\n
(5) Dilute 1 volume of solution (2) to 10 volumes.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with end-capped octylsilyl silica gel for chromatography (5 \u00b5m) (Inertsil C8 is suitable).<\/p>\n
(b) Use gradient elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1.3 mL per minute.<\/p>\n
(d) Use a column temperature of 50\u00b0.<\/p>\n
(e) Use a detection wavelength of 254 nm.<\/p>\n
(f) Inject 10 \u00b5L of each solution.<\/p>\n
MOBILE PHASE<\/h3>\n
Mobile phase A<\/em>\u00a0 0.05% v\/v trifluoroacetic acid.<\/p>\n
Mobile phase B<\/em>\u00a0 5 volumes of tetrahydrofuran, 15 volumes of methanol and 80 volumes of acetonitrile.<\/p>\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 Comment<\/strong><\/td>\n<\/tr>\n
0-5<\/td>\n 90<\/td>\n 10<\/td>\n isocratic<\/td>\n<\/tr>\n
5-20<\/td>\n 90\u219265<\/td>\n 10\u219235<\/td>\n linear gradient<\/td>\n<\/tr>\n
20-30<\/td>\n 65<\/td>\n 35<\/td>\n isocratic<\/td>\n<\/tr>\n
30-31<\/td>\n 65\u219290<\/td>\n 35\u219210<\/td>\n linear gradient<\/td>\n<\/tr>\n
31-37<\/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 oxytetracycline (retention time about 7 minutes) are: impurity A, about 0.9; impurity B, about 1.2; impurity C, about 1.3; impurity D, about 1.4; impurity E, about 2.2; impurity F, about 2.3.<\/p>\n
SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the peak-to-valley ratio is at least 3.0, where Hp is the height above the baseline of the peak due to impurity A and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to oxytetracycline.<\/p>\n
The test is not valid unless, in the chromatogram obtained with solution (3), the peak-to-valley ratio is at least 3.0, where Hp is the height above the baseline of the peak due to impurity B and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to oxytetracycline.<\/p>\n
LIMITS<\/h3>\n
Identify any peak corresponding to impurities A, B, C, D, E and F in the chromatogram obtained with solution (1), using the chromatogram obtained with solution (3). Identify the peak due to patent blue V if present in the chromatogram obtained with solution (1), using the chromatogram obtained with solution (4). Multiply the areas of the peaks due to Impurity D and E by a correction factor of 0.4.<\/p>\n
In the chromatogram obtained with solution (1):<\/p>\n
the area of any peak corresponding to impurity A is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1.0%);<\/p>\n
the area of any peak corresponding to impurity B is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (2.5%);<\/p>\n
the area of any peak corresponding to impurity C is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (2.0%);<\/p>\n
the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1.0%);<\/p>\n
the sum of the areas of all the secondary peaks is not greater than 7 times the area of the principal peak in the chromatogram obtained with solution (2) (7.0%).<\/p>\n
Disregard any peak due to patent blue V and any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.1%).<\/p>\n
ASSAY<\/h2>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in a mixture of 20 volumes of acetonitrile and 80 volumes of 0.01M oxalic acid (solvent A). Prepare the solutions immediately before use.<\/p>\n
(1) Dilute a quantity of the cutaneous spray containing 0.16 g of Oxytetracycline Hydrochloride with 150 mL of solvent A and shake. Dilute to 200 mL and filter (Whatman GF\/C filter is suitable). Dilute 1 volume of the filtrate to 10 volumes.<\/p>\n
(2) 0.0074% w\/v of oxytetracycline BPCRS.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
The chromatographic conditions stated under Related substances may be used.<\/p>\n
DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{9<\/sub>,HCl in the spray using the declared content of C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{9<\/sub> in oxytetracycline BPCRS. Each mg of C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{9<\/sub> is equivalent to 1.079 mg of C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{9<\/sub>,HCl.<\/p>\n}}}}}}}}}}}}}}}}
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include those listed under Oxytetracycline hydrochloride.<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Tetracycline antibacterial. DEFINITION Oxytetracycline Cutaneous Spray contains Oxytetracycline Hydrochloride in a suitable vehicle. The cutaneous spray complies with the requirements stated under Veterinary Liquid Preparations for Cutaneous Application and with the following requirements. Content of oxytetracycline hydrochloride, C22H24N2O9,HCl 90.0 to 110.0% of the stated amount….<\/p>\n","protected":false},"author":5,"featured_media":24710,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[176],"tags":[],"class_list":["post-24709","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\/24709","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=24709"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/24709\/revisions"}],"predecessor-version":[{"id":24720,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/24709\/revisions\/24720"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/24710"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=24709"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=24709"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=24709"}],"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	Comment<\/strong><\/td>\n<\/tr>\n
0-5<\/td>\n	90<\/td>\n	10<\/td>\n	isocratic<\/td>\n<\/tr>\n
5-20<\/td>\n	90\u219265<\/td>\n	10\u219235<\/td>\n	linear gradient<\/td>\n<\/tr>\n
20-30<\/td>\n	65<\/td>\n	35<\/td>\n	isocratic<\/td>\n<\/tr>\n
30-31<\/td>\n	65\u219290<\/td>\n	35\u219210<\/td>\n	linear gradient<\/td>\n<\/tr>\n
31-37<\/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 oxytetracycline (retention time about 7 minutes) are: impurity A, about 0.9; impurity B, about 1.2; impurity C, about 1.3; impurity D, about 1.4; impurity E, about 2.2; impurity F, about 2.3.<\/p>\n SYSTEM SUITABILITY<\/h3>\n The test is not valid unless, in the chromatogram obtained with solution (3), the peak-to-valley ratio is at least 3.0, where Hp is the height above the baseline of the peak due to impurity A and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to oxytetracycline.<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (3), the peak-to-valley ratio is at least 3.0, where Hp is the height above the baseline of the peak due to impurity B and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to oxytetracycline.<\/p>\n LIMITS<\/h3>\n Identify any peak corresponding to impurities A, B, C, D, E and F in the chromatogram obtained with solution (1), using the chromatogram obtained with solution (3). Identify the peak due to patent blue V if present in the chromatogram obtained with solution (1), using the chromatogram obtained with solution (4). Multiply the areas of the peaks due to Impurity D and E by a correction factor of 0.4.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to impurity A is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1.0%);<\/p>\n the area of any peak corresponding to impurity B is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (2.5%);<\/p>\n the area of any peak corresponding to impurity C is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (2.0%);<\/p>\n the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1.0%);<\/p>\n the sum of the areas of all the secondary peaks is not greater than 7 times the area of the principal peak in the chromatogram obtained with solution (2) (7.0%).<\/p>\n Disregard any peak due to patent blue V and any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.1%).<\/p>\n ASSAY<\/h2>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions in a mixture of 20 volumes of acetonitrile and 80 volumes of 0.01M oxalic acid (solvent A). Prepare the solutions immediately before use.<\/p>\n (1) Dilute a quantity of the cutaneous spray containing 0.16 g of Oxytetracycline Hydrochloride with 150 mL of solvent A and shake. Dilute to 200 mL and filter (Whatman GF\/C filter is suitable). Dilute 1 volume of the filtrate to 10 volumes.<\/p>\n (2) 0.0074% w\/v of oxytetracycline BPCRS.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/h3>\n The chromatographic conditions stated under Related substances may be used.<\/p>\n DETERMINATION OF CONTENT<\/h3>\n Calculate the content of C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{9<\/sub>,HCl in the spray using the declared content of C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{9<\/sub> in oxytetracycline BPCRS. Each mg of C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{9<\/sub> is equivalent to 1.079 mg of C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{9<\/sub>,HCl.<\/p>\n}}}}}}}}}}}}}}}} IMPURITIES<\/h2>\n The impurities limited by the requirements of this monograph include those listed under Oxytetracycline hydrochloride.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Tetracycline antibacterial. DEFINITION Oxytetracycline Cutaneous Spray contains Oxytetracycline Hydrochloride in a suitable vehicle. The cutaneous spray complies with the requirements stated under Veterinary Liquid Preparations for Cutaneous Application and with the following requirements. Content of oxytetracycline hydrochloride, C22H24N2O9,HCl 90.0 to 110.0% of the stated amount….<\/p>\n","protected":false},"author":5,"featured_media":24710,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[176],"tags":[],"class_list":["post-24709","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\/24709","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=24709"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/24709\/revisions"}],"predecessor-version":[{"id":24720,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/24709\/revisions\/24720"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/24710"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=24709"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=24709"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=24709"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

CHROMATOGRAPHIC CONDITIONS<\/h3>\nThe chromatographic conditions stated under Related substances may be used.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h3>\n
The chromatographic conditions stated under Related substances may be used.<\/p>\n