{"id":22301,"date":"2025-10-29T17:52:46","date_gmt":"2025-10-29T10:52:46","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=22301"},"modified":"2025-10-29T17:52:46","modified_gmt":"2025-10-29T10:52:46","slug":"tetracycline-tablets","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/tetracycline-tablets\/","title":{"rendered":"Tetracycline 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
Tetracycline Tablets contain Tetracycline Hydrochloride.<\/p>\n
The tablets comply with the requirements stated under Tablets and with the following requirements.<\/em><\/p>\n
Content of tetracycline hydrochloride, C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{8<\/sub>,HCl<\/strong><\/p>\n}}}}
95.0 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 210 to 400 nm.<\/p>\n
The UV spectrum of the principal peak in the chromatogram obtained with solution (1) is concordant with that of the peak in the chromatogram obtained with solution (2);
\nthe 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
Dissolution<\/h3>\n
Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n
TEST CONDITIONS<\/h4>\n
(a) Use Apparatus 1, rotating the basket at 100 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 sample of the medium. Measure the absorbance of the filtered sample, suitably diluted if necessary, at the maximum at 353 nm, Appendix II B.<\/p>\n
DETERMINATION OF CONTENT<\/h4>\n
Calculate the total content of tetracycline hydrochloride, C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{8<\/sub>,HCl, in the medium taking 310 as the value of A(1%, 1 cm) at the maximum at 353 nm.<\/p>\n}}}}
LIMITS<\/h4>\n
The amount of tetracycline hydrochloride released is not less than 70% (Q) of the stated amount.<\/p>\n
Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in mobile phase A.<\/p>\n
(1) Dissolve, with the aid of ultrasound, a quantity of the powdered tablets containing 25 mg of Tetracycline Hydrochloride in sufficient mobile phase A, dilute to produce 250 mL and filter.<\/p>\n
(2) Dilute 3 volumes of solution (1) to 200 volumes.<\/p>\n
(3) 0.0003% w\/v of 4-epitetracycline hydrochloride EPCRS (impurity A), 0.0001% w\/v each of anhydrotetracycline hydrochloride EPCRS (impurity C) and 4-epianhydrotetracycline hydrochloride EPCRS (impurity D) and 0.00001% w\/v of tetracycline hydrochloride BPCRS.<\/p>\n
(4) 0.0025% w\/v each of 4-epitetracycline hydrochloride EPCRS (impurity A), anhydrotetracycline hydrochloride EPCRS (impurity C), 4-epianhydrotetracycline hydrochloride EPCRS (impurity D) and tetracycline hydrochloride BPCRS.<\/p>\n
(5) Dilute 1 volume of solution (2) to 15 volumes.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (3 \u00b5m) (Phenomenex Prodigy ODS 3 is suitable).<\/p>\n
(b) Use gradient elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1 mL per minute.<\/p>\n
(d) Use an autosampler temperature of 4\u00b0.<\/p>\n
(e) Use a column temperature of 50\u00b0.<\/p>\n
(f) Use a detection wavelength of 280 nm.<\/p>\n
(g) Inject 10 \u00b5L of each solution.<\/p>\n
MOBILE PHASE<\/h4>\n
Mobile phase A 0.1% v\/v of orthophosphoric acid.<\/p>\n
Mobile phase B acetonitrile.<\/p>\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
0-7.5<\/td>\n 85\u219260<\/td>\n 15\u219240<\/td>\n linear gradient<\/td>\n<\/tr>\n
7.5-7.6<\/td>\n 60\u219285<\/td>\n 40\u219215<\/td>\n linear gradient<\/td>\n<\/tr>\n
7.6-10<\/td>\n 85<\/td>\n 15<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (4):<\/p>\n
the resolution between the peaks due to impurity A and tetracycline is at least 2.5; the resolution between the peaks due to impurities C and D is at least 2.5.<\/p>\n
CALCULATION OF IMPURITIES<\/h4>\n
For impurities A, C and D, use the concentration of each impurity in solution (3). For impurity B, use the concentration of tetracycline in solution (2).<\/p>\n
For any other impurity, use the concentration of tetracycline in solution (5).<\/p>\n
For the reporting threshold, use the concentration of tetracycline in solution (5). For peak identification, use solution (3).<\/p>\n
Tetracycline retention time: about 4 minutes.<\/p>\n
Relative retention: impurity A, about 0.9; impurity B, about 1.3; impurity D, about 1.7 and impurity C, about 1.8.<\/p>\n
LIMITS<\/h4>\n
\u2014 impurity A: not more than 4.0%;<\/p>\n
\u2014 impurity B: not more than 1.5%;<\/p>\n
\u2014 impurity C: not more than 3.0%;<\/p>\n
\u2014 impurity D: not more than 2.0%;<\/p>\n
\u2014 unspecified impurities: for each impurity, not more than 0.1%;<\/p>\n
\u2014 total impurities: not more than 4.0%;<\/p>\n
\u2014 reporting threshold: 0.05%.<\/p>\n
ASSAY<\/h2>\n
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions in mobile phase A.<\/p>\n
(1) Dissolve, with the aid of ultrasound, a quantity of the powdered tablets containing 25 mg of Tetracycline Hydrochloride in sufficient mobile phase A, dilute to produce 250 mL and filter.<\/p>\n
(2) 0.01% w\/v of tetracycline hydrochloride BPCRS.<\/p>\n
(3) 0.0025% w\/v each of 4-epitetracycline hydrochloride EPCRS (impurity A), anhydrotetracycline hydrochloride EPCRS (impurity C), 4-epianhydrotetracycline hydrochloride EPCRS (impurity D) and tetracycline hydrochloride BPCRS.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/p>\n
The chromatographic conditions described under Related substances may be used.<\/p>\n
SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless, in the chromatogram obtained with solution (3):<\/p>\n
the resolution between the peaks due to impurity A and tetracycline is at least 2.5; the resolution between the peaks due to impurities C and D is at least 2.5.<\/p>\n
DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{8<\/sub>,HCl in the tablets from the chromatograms obtained and using the declared content of C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{8<\/sub>,HCl in tetracycline hydrochloride BPCRS.<\/p>\n}}}}}}}}
IMPURITIES<\/h3>\n
The impurities limited by the requirements of this monograph include impurities A, B, C and D listed under Tetracycline Hydrochloride.<\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Tetracycline antibacterial. DEFINITION Tetracycline Tablets contain Tetracycline Hydrochloride. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of tetracycline hydrochloride, C22H24N2O8,HCl 95.0 to 105.0% of the stated amount. IDENTIFICATION In the Assay, record the UV spectrum of the principal…<\/p>\n","protected":false},"author":5,"featured_media":22302,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-22301","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22301","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=22301"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22301\/revisions"}],"predecessor-version":[{"id":22305,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22301\/revisions\/22305"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22302"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22301"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22301"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22301"}],"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
0-7.5<\/td>\n	85\u219260<\/td>\n	15\u219240<\/td>\n	linear gradient<\/td>\n<\/tr>\n
7.5-7.6<\/td>\n	60\u219285<\/td>\n	40\u219215<\/td>\n	linear gradient<\/td>\n<\/tr>\n
7.6-10<\/td>\n	85<\/td>\n	15<\/td>\n	re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n SYSTEM SUITABILITY<\/h4>\n The test is not valid unless, in the chromatogram obtained with solution (4):<\/p>\n the resolution between the peaks due to impurity A and tetracycline is at least 2.5; the resolution between the peaks due to impurities C and D is at least 2.5.<\/p>\n CALCULATION OF IMPURITIES<\/h4>\n For impurities A, C and D, use the concentration of each impurity in solution (3). For impurity B, use the concentration of tetracycline in solution (2).<\/p>\n For any other impurity, use the concentration of tetracycline in solution (5).<\/p>\n For the reporting threshold, use the concentration of tetracycline in solution (5). For peak identification, use solution (3).<\/p>\n Tetracycline retention time: about 4 minutes.<\/p>\n Relative retention: impurity A, about 0.9; impurity B, about 1.3; impurity D, about 1.7 and impurity C, about 1.8.<\/p>\n LIMITS<\/h4>\n \u2014 impurity A: not more than 4.0%;<\/p>\n \u2014 impurity B: not more than 1.5%;<\/p>\n \u2014 impurity C: not more than 3.0%;<\/p>\n \u2014 impurity D: not more than 2.0%;<\/p>\n \u2014 unspecified impurities: for each impurity, not more than 0.1%;<\/p>\n \u2014 total impurities: not more than 4.0%;<\/p>\n \u2014 reporting threshold: 0.05%.<\/p>\n ASSAY<\/h2>\n Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions in mobile phase A.<\/p>\n (1) Dissolve, with the aid of ultrasound, a quantity of the powdered tablets containing 25 mg of Tetracycline Hydrochloride in sufficient mobile phase A, dilute to produce 250 mL and filter.<\/p>\n (2) 0.01% w\/v of tetracycline hydrochloride BPCRS.<\/p>\n (3) 0.0025% w\/v each of 4-epitetracycline hydrochloride EPCRS (impurity A), anhydrotetracycline hydrochloride EPCRS (impurity C), 4-epianhydrotetracycline hydrochloride EPCRS (impurity D) and tetracycline hydrochloride BPCRS.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n The chromatographic conditions described under Related substances may be used.<\/p>\n SYSTEM SUITABILITY<\/h3>\n The test is not valid unless, in the chromatogram obtained with solution (3):<\/p>\n the resolution between the peaks due to impurity A and tetracycline is at least 2.5; the resolution between the peaks due to impurities C and D is at least 2.5.<\/p>\n DETERMINATION OF CONTENT<\/h3>\n Calculate the content of C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{8<\/sub>,HCl in the tablets from the chromatograms obtained and using the declared content of C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{8<\/sub>,HCl in tetracycline hydrochloride BPCRS.<\/p>\n}}}}}}}} IMPURITIES<\/h3>\n The impurities limited by the requirements of this monograph include impurities A, B, C and D listed under Tetracycline Hydrochloride.<\/p>\n","protected":false},"excerpt":{"rendered":" Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Tetracycline antibacterial. DEFINITION Tetracycline Tablets contain Tetracycline Hydrochloride. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of tetracycline hydrochloride, C22H24N2O8,HCl 95.0 to 105.0% of the stated amount. IDENTIFICATION In the Assay, record the UV spectrum of the principal…<\/p>\n","protected":false},"author":5,"featured_media":22302,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-22301","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22301","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=22301"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22301\/revisions"}],"predecessor-version":[{"id":22305,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/22301\/revisions\/22305"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/22302"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=22301"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=22301"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=22301"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

TESTS<\/h2>\n

Dissolution<\/h3>\nComply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n

TEST CONDITIONS<\/h4>\n(a) Use Apparatus 1, rotating the basket at 100 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 sample of the medium. Measure the absorbance of the filtered sample, suitably diluted if necessary, at the maximum at 353 nm, Appendix II B.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\nCalculate the total content of tetracycline hydrochloride, C22<\/sub>H24<\/sub>N2<\/sub>O8<\/sub>,HCl, in the medium taking 310 as the value of A(1%, 1 cm) at the maximum at 353 nm.<\/p>\n

LIMITS<\/h4>\nThe amount of tetracycline hydrochloride released is not less than 70% (Q) of the stated amount.<\/p>\n

SYSTEM SUITABILITY<\/h4>\nThe test is not valid unless, in the chromatogram obtained with solution (4):<\/p>\nthe resolution between the peaks due to impurity A and tetracycline is at least 2.5; the resolution between the peaks due to impurities C and D is at least 2.5.<\/p>\n

SYSTEM SUITABILITY<\/h3>\nThe test is not valid unless, in the chromatogram obtained with solution (3):<\/p>\nthe resolution between the peaks due to impurity A and tetracycline is at least 2.5; the resolution between the peaks due to impurities C and D is at least 2.5.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\nCalculate the content of C22<\/sub>H24<\/sub>N2<\/sub>O8<\/sub>,HCl in the tablets from the chromatograms obtained and using the declared content of C22<\/sub>H24<\/sub>N2<\/sub>O8<\/sub>,HCl in tetracycline hydrochloride BPCRS.<\/p>\n

Dissolution<\/h3>\n
Comply with the dissolution test for tablets and capsules, Appendix XII B1.<\/p>\n

TEST CONDITIONS<\/h4>\n
(a) Use Apparatus 1, rotating the basket at 100 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 sample of the medium. Measure the absorbance of the filtered sample, suitably diluted if necessary, at the maximum at 353 nm, Appendix II B.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\n
Calculate the total content of tetracycline hydrochloride, C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{8<\/sub>,HCl, in the medium taking 310 as the value of A(1%, 1 cm) at the maximum at 353 nm.<\/p>\n}}}}

LIMITS<\/h4>\n
The amount of tetracycline hydrochloride released is not less than 70% (Q) of the stated amount.<\/p>\n

SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (4):<\/p>\n
the resolution between the peaks due to impurity A and tetracycline is at least 2.5; the resolution between the peaks due to impurities C and D is at least 2.5.<\/p>\n

SYSTEM SUITABILITY<\/h3>\n
The test is not valid unless, in the chromatogram obtained with solution (3):<\/p>\n
the resolution between the peaks due to impurity A and tetracycline is at least 2.5; the resolution between the peaks due to impurities C and D is at least 2.5.<\/p>\n

DETERMINATION OF CONTENT<\/h3>\n
Calculate the content of C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{8<\/sub>,HCl in the tablets from the chromatograms obtained and using the declared content of C_{22<\/sub>H_{24<\/sub>N_{2<\/sub>O_{8<\/sub>,HCl in tetracycline hydrochloride BPCRS.<\/p>\n}}}}}}}}