{"id":22810,"date":"2025-10-30T16:59:35","date_gmt":"2025-10-30T09:59:35","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=22810"},"modified":"2025-10-30T16:59:35","modified_gmt":"2025-10-30T09:59:35","slug":"chlortetracycline-tablets","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/chlortetracycline-tablets\/","title":{"rendered":"Chlortetracycline Tablets"},"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
Chlortetracycline Tablets contain Chlortetracycline Hydrochloride.<\/p>\n
The tablets comply with the requirements stated under Tablets and with the following requirements.<\/em><\/p>\n
Content of chlortetracycline hydrochloride, C_{22<\/sub>H_{23<\/sub>ClN_{2<\/sub>O_{8<\/sub>,HCl<\/strong><\/p>\n}}}}
95.0 to 110.0% 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
(1) Extract a quantity of the powdered tablets containing 10 mg of Chlortetracycline Hydrochloride with 20 mL of methanol and centrifuge.<\/p>\n
(2) 0.05% w\/v of chlortetracycline hydrochloride BPCRS in methanol.<\/p>\n
(3) 0.05% w\/v of each of chlortetracycline hydrochloride BPCRS, tetracycline hydrochloride BPCRS and metacycline hydrochloride BPCRS in methanol.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
(a) Use silica gel H as the coating. Adjust the pH of a 10% w\/v solution of disodium edetate to 8.0 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. At the time of use, dry the plate in an oven 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, allow it to dry 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 three clearly separated spots.<\/p>\n
CONFIRMATION<\/h3>\n
The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).<\/p>\n
B. To a quantity of the powdered tablets containing 10 mg of Chlortetracycline Hydrochloride add 20 mL of warm ethanol (96%), allow to stand for 20 minutes, filter and evaporate to dryness on a water bath. A 0.1% w\/v solution of the residue in phosphate buffer pH 7.6, when heated at 100\u00b0 for 1 minute, exhibits a strong blue fluorescence in ultraviolet light.<\/p>\n
TESTS<\/h2>\n
Tetracycline hydrochloride and 4-epichlortetracycline hydrochloride<\/h3>\n
Not more than 8.0% and 6.0% respectively, determined as described under Assay. Inject separately solutions (1) and (4).<\/p>\n
Dissolution<\/h3>\n
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n
TEST CONDITIONS<\/h4>\n
(a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute.<\/p>\n
(b) Use 900 mL of 0.1M hydrochloric acid, at a temperature of 37\u00b0, as the medium.<\/p>\n
PROCEDURE<\/h4>\n
After 45 minutes withdraw a 10 mL sample of the medium and filter. Measure the absorbance of the filtered sample, suitably diluted with the dissolution medium if necessary, at the maximum at 266 nm, Appendix II B, using 0.1M hydrochloric acid in the reference cell.<\/p>\n
DETERMINATION OF CONTENT<\/h4>\n
Calculate the total content of chlortetracycline hydrochloride, C_{22<\/sub>H_{23<\/sub>ClN_{2<\/sub>O_{8<\/sub>,HCl, in the medium taking 346 as the value of A(1%, 1 cm) at the maximum at 266 nm.<\/p>\n}}}}
ASSAY<\/h2>\n
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared immediately before use.<\/p>\n
(1) Mix a quantity of the powdered tablets containing 25 mg of Chlortetracycline Hydrochloride with 50 mL of 0.01M hydrochloric acid, shake for 10 minutes, dilute to 100 mL with 0.01M hydrochloric acid and filter (GF\/C paper is suitable).<\/p>\n
(2) 0.025% w\/v of chlortetracycline hydrochloride BPCRS in 0.01M hydrochloric acid.<\/p>\n
(3) 0.025% w\/v of each of chlortetracycline hydrochloride BPCRS and 4-epichlortetracycline hydrochloride in 0.01M hydrochloric acid.<\/p>\n
(4) 0.002% w\/v of tetracycline hydrochloride BPCRS and 0.0015% w\/v of 4-epichlortetracycline hydrochloride in 0.01M hydrochloric acid.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h3>\n
(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (10 \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 2 mL per minute.<\/p>\n
(d) Use a column temperature of 40\u00b0.<\/p>\n
(e) Use a detection wavelength of 355 nm.<\/p>\n
(f) Inject 20 \u00b5L of each solution.<\/p>\n
MOBILE PHASE<\/h3>\n
20 volumes of dimethylformamide and 80 volumes of 0.1M oxalic acid the pH of which has been adjusted to 2.2 with triethylamine.<\/p>\n
SYSTEM SUITABILITY<\/h3>\n
The assay is not valid unless, in the chromatogram obtained with solution (3), the resolution between the two principal peaks is at least 1.5.<\/p>\n
DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of C_{22<\/sub>H_{23<\/sub>ClN_{2<\/sub>O_{8<\/sub>,HCl in the tablets using the declared content of C_{22<\/sub>H_{23<\/sub>ClN_{2<\/sub>O_{8<\/sub>,HCl in chlortetracycline hydrochloride BPCRS.<\/p>\n","protected":false},"excerpt":{"rendered":"}}}}}}}}
Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Tetracycline antibacterial. DEFINITION Chlortetracycline Tablets contain Chlortetracycline Hydrochloride. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of chlortetracycline hydrochloride, C22H23ClN2O8,HCl 95.0 to 110.0% of the stated amount. IDENTIFICATION A. Carry out the method for thin-layer chromatography, Appendix III…<\/p>\n","protected":false},"author":5,"featured_media":22812,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[176],"tags":[],"class_list":["post-22810","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\/22810","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=22810"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22810\/revisions"}],"predecessor-version":[{"id":22817,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22810\/revisions\/22817"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22812"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22810"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22810"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22810"}],"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 three clearly separated spots.<\/p>\n

TESTS<\/h2>\n

Tetracycline hydrochloride and 4-epichlortetracycline hydrochloride<\/h3>\nNot more than 8.0% and 6.0% respectively, determined as described under Assay. Inject separately solutions (1) and (4).<\/p>\n

Dissolution<\/h3>\nComply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n

TEST CONDITIONS<\/h4>\n(a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute.<\/p>\n(b) Use 900 mL of 0.1M hydrochloric acid, at a temperature of 37\u00b0, as the medium.<\/p>\n

PROCEDURE<\/h4>\nAfter 45 minutes withdraw a 10 mL sample of the medium and filter. Measure the absorbance of the filtered sample, suitably diluted with the dissolution medium if necessary, at the maximum at 266 nm, Appendix II B, using 0.1M hydrochloric acid in the reference cell.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\nCalculate the total content of chlortetracycline hydrochloride, C22<\/sub>H23<\/sub>ClN2<\/sub>O8<\/sub>,HCl, in the medium taking 346 as the value of A(1%, 1 cm) at the maximum at 266 nm.<\/p>\n

MOBILE PHASE<\/h3>\n20 volumes of dimethylformamide and 80 volumes of 0.1M oxalic acid the pH of which has been adjusted to 2.2 with triethylamine.<\/p>\n

SYSTEM SUITABILITY<\/h3>\nThe assay is not valid unless, in the chromatogram obtained with solution (3), the resolution between the two principal peaks is at least 1.5.<\/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 three clearly separated spots.<\/p>\n

Tetracycline hydrochloride and 4-epichlortetracycline hydrochloride<\/h3>\n
Not more than 8.0% and 6.0% respectively, determined as described under Assay. Inject separately solutions (1) and (4).<\/p>\n

Dissolution<\/h3>\n
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n

TEST CONDITIONS<\/h4>\n
(a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute.<\/p>\n
(b) Use 900 mL of 0.1M hydrochloric acid, at a temperature of 37\u00b0, as the medium.<\/p>\n

PROCEDURE<\/h4>\n
After 45 minutes withdraw a 10 mL sample of the medium and filter. Measure the absorbance of the filtered sample, suitably diluted with the dissolution medium if necessary, at the maximum at 266 nm, Appendix II B, using 0.1M hydrochloric acid in the reference cell.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\n
Calculate the total content of chlortetracycline hydrochloride, C_{22<\/sub>H_{23<\/sub>ClN_{2<\/sub>O_{8<\/sub>,HCl, in the medium taking 346 as the value of A(1%, 1 cm) at the maximum at 266 nm.<\/p>\n}}}}

MOBILE PHASE<\/h3>\n
20 volumes of dimethylformamide and 80 volumes of 0.1M oxalic acid the pH of which has been adjusted to 2.2 with triethylamine.<\/p>\n

SYSTEM SUITABILITY<\/h3>\n
The assay is not valid unless, in the chromatogram obtained with solution (3), the resolution between the two principal peaks is at least 1.5.<\/p>\n