{"id":24721,"date":"2025-11-03T15:19:15","date_gmt":"2025-11-03T08:19:15","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=24721"},"modified":"2025-11-03T15:19:15","modified_gmt":"2025-11-03T08:19:15","slug":"oxytetracycline-veterinary-oral-powder","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/oxytetracycline-veterinary-oral-powder\/","title":{"rendered":"Oxytetracycline Veterinary Oral Powder"},"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 Veterinary Oral Powder is a mixture of Oxytetracycline Hydrochloride and a suitable diluent.<\/p>\n
Content of oxytetracycline hydrochloride, C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{9<\/sub>,HCl<\/p>\n}}}}
90.0 to 105.0% of the stated amount.<\/p>\n
The veterinary oral powder complies with the requirements stated under Veterinary Oral Powders and with the following requirements.<\/em><\/p>\n
IDENTIFICATION<\/h2>\n
A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<\/p>\n
(1) Extract a quantity of the oral powder containing 10 mg of Oxytetracycline Hydrochloride with 20 mL of methanol, centrifuge and use the supernatant liquid.<\/p>\n
(2) 0.05% w\/v of oxytetracycline hydrochloride BPCRS in methanol.<\/p>\n
(3) 0.05% w\/v of each of oxytetracycline hydrochloride BPCRS and demeclocycline hydrochloride BPCRS in methanol.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
(a) Use a silica gel precoated plate (Merck silica gel 60 plates are suitable). Adjust the pH of a 10% w\/v solution of disodium edetate to 7.0 with 10M sodium hydroxide and spray the solution evenly onto the plate (about 10 mL for a plate 100 mm \u00d7 200 mm). Allow the plate to dry in a horizontal position for at least 1 hour. Before use, dry the plate at 110\u00b0 for 1 hour.<\/p>\n
(b) Use the mobile phase as described below.<\/p>\n
(c) Apply 1 \u00b5L of each solution.<\/p>\n
(d) Develop the plate to 15 cm.<\/p>\n
(e) After removal of the plate, dry it in a current of air and examine under ultraviolet light (365 nm).<\/p>\n
MOBILE PHASE<\/h3>\n
6 volumes of water, 35 volumes of methanol and 59 volumes of dichloromethane.<\/p>\n
SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated spots.<\/p>\n
CONFIRMATION<\/h3>\n
The principal spot in the chromatogram obtained with solution (1) is similar in position, colour and size to that in the chromatogram obtained with solution (2).<\/p>\n
B. To a quantity of the powder containing 0.4 mg of Oxytetracycline Hydrochloride add 5 mL of a 1% w\/v solution of
\nsodium carbonate, shake and add 2 mL of diazobenzenesulfonic acid solution. A light brown colour is produced.<\/p>\n
C. Shake a quantity of the powder containing 0.1 g of Oxytetracycline Hydrochloride with 10 mL of 2M nitric acid and filter. Decolourise the filtrate with activated charcoal and filter again. The filtrate yields the reactions characteristic of chlorides, Appendix VI.<\/p>\n
Related substances<\/h3>\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 oral powder 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) Dilute 1 volume of solution (2) to 10 volumes.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with end-capped octylsilyl silica gel for chromatography (5 \u00b5m) (Intertsil 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<\/h4>\n
Mobile phase A\u00a0<\/em> 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
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
20-21<\/td>\n 65\u219290<\/td>\n 35\u219210<\/td>\n linear gradient<\/td>\n<\/tr>\n
21-27<\/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<\/h4>\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<\/h4>\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).<\/p>\n
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 peaks corresponding to impurity A, impurity B and impurity C are not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (2.0% of each);<\/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 5 times the area of the principal peak in the chromatogram obtained with solution (2) (5.0%).<\/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
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) Shake, with the aid of ultrasound, a quantity of the powder containing 0.16 g of Oxytetracycline Hydrochloride with 150 mL of solvent A. 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 powder 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 Veterinary Oral Powder is a mixture of Oxytetracycline Hydrochloride and a suitable diluent. Content of oxytetracycline hydrochloride, C22H24N2O9,HCl 90.0 to 105.0% of the stated amount. The veterinary oral powder complies with the requirements stated under Veterinary Oral Powders and with the…<\/p>\n","protected":false},"author":5,"featured_media":24723,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[176],"tags":[],"class_list":["post-24721","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\/24721","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=24721"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/24721\/revisions"}],"predecessor-version":[{"id":24747,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/24721\/revisions\/24747"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/24723"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=24721"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=24721"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=24721"}],"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
20-21<\/td>\n	65\u219290<\/td>\n	35\u219210<\/td>\n	linear gradient<\/td>\n<\/tr>\n
21-27<\/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<\/h4>\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<\/h4>\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).<\/p>\n 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 peaks corresponding to impurity A, impurity B and impurity C are not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (2.0% of each);<\/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 5 times the area of the principal peak in the chromatogram obtained with solution (2) (5.0%).<\/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 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) Shake, with the aid of ultrasound, a quantity of the powder containing 0.16 g of Oxytetracycline Hydrochloride with 150 mL of solvent A. 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 powder 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 Veterinary Oral Powder is a mixture of Oxytetracycline Hydrochloride and a suitable diluent. Content of oxytetracycline hydrochloride, C22H24N2O9,HCl 90.0 to 105.0% of the stated amount. The veterinary oral powder complies with the requirements stated under Veterinary Oral Powders and with the…<\/p>\n","protected":false},"author":5,"featured_media":24723,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[176],"tags":[],"class_list":["post-24721","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\/24721","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=24721"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/24721\/revisions"}],"predecessor-version":[{"id":24747,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/24721\/revisions\/24747"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/24723"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=24721"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=24721"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=24721"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

MOBILE PHASE<\/h3>\n6 volumes of water, 35 volumes of methanol and 59 volumes of dichloromethane.<\/p>\n

SYSTEM SUITABILITY<\/h3>\nThe test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated spots.<\/p>\n

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

MOBILE PHASE<\/h3>\n
6 volumes of water, 35 volumes of methanol and 59 volumes of dichloromethane.<\/p>\n

SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated spots.<\/p>\n

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