{"id":21454,"date":"2025-10-28T15:50:01","date_gmt":"2025-10-28T08:50:01","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=21454"},"modified":"2025-10-28T15:50:01","modified_gmt":"2025-10-28T08:50:01","slug":"tigecycline-for-infusion","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/tigecycline-for-infusion\/","title":{"rendered":"Tigecycline for Infusion"},"content":{"rendered":"

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

Glycylcycline antibacterial.<\/p>\n

DEFINITION<\/h2>\n
Tigecycline for Infusion is a sterile material consisting of Tigecycline with or without excipients. It is supplied in a sealed container.<\/p>\n
The contents of the sealed container comply with the requirements for Powders for Injections or Infusions stated under<\/p>\n
Parenteral Preparations and with the following requirements.<\/p>\n
Content of tigecycline, C_{29<\/sub>H_{39<\/sub>N_{5<\/sub>O_{8<\/sub><\/strong><\/p>\n}}}}
95.0 to 110.0% of the stated amount.<\/p>\n
IDENTIFICATION<\/h2>\n
The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum produced with tigecycline EPCRS. If the spectra show differences, record a new spectrum after recrystallisation from methanol.<\/p>\n
TESTS<\/h2>\n
Acidity<\/h3>\n
pH of a 1% w\/v solution, 5.0 to 6.5. Appendix V L.<\/p>\n
Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in a solution containing 0.44% w\/v of dipotassium hydrogen orthophosphate and 0.05% w\/v of sodium hydrogensulfite in water, adjusted to pH 8.0 with 1M potassium hydroxide. Store solutions at 10\u00b0 and protect from light. Use solutions within 12 hours of preparation.<\/p>\n
(1) Dissolve a quantity of the contents of the sealed container to produce a solution containing 0.05% w\/v of Tigecycline.<\/p>\n
(2) Dilute 1 volume of solution (1) to 100 volumes.<\/p>\n
(3) Dilute 1 volume of solution (2) to 10 volumes.<\/p>\n
(4) 0.05% w\/v of tigecycline for system suitability EPCRS (impurity A), 0.00024% w\/v of tigecycline impurity B EPCRS and 0.00024% w\/v of minocycline hydrochloride BPCRS (impurity C).<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (15 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (3 \u03bcm) (Luna C18 is suitable).<\/p>\n
(b) Use gradient elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1.0 mL per minute.<\/p>\n
(d) Use a column temperature of 30\u00b0.<\/p>\n
(e) Use an autosampler temperature of 10\u00b0.<\/p>\n
(f) Use a detection wavelength of 248 nm.<\/p>\n
(g) Inject 25 \u03bcL of each solution.<\/p>\n
MOBILE PHASE<\/h4>\n
Mobile phase A 50 volumes of acetonitrile, 950 volumes of a solution containing 0.46% w\/v of dipotassium hydrogen orthophosphate and 0.10% w\/v of disodium edetate in water, previously adjusted to pH 6.4 with orthophosphoric acid.<\/p>\n
Mobile phase B 500 volumes of acetonitrile, 500 volumes of a solution containing 0.87% w\/v of dipotassium hydrogen orthophosphate and 0.19% w\/v of disodium edetate in water, previously adjusted to pH 6.4 with orthophosphoric acid.<\/p>\n\n\n\n\n\n\n\n\n\n
Time (Minutes)\u00a0<\/strong><\/td>\n Mobile phase A (% v\/v)\u00a0<\/strong><\/td>\n Mobile phase B (% v\/v)\u00a0<\/strong><\/td>\n Comment<\/strong><\/td>\n<\/tr>\n
0-2<\/td>\n 85<\/td>\n 15<\/td>\n isocratic<\/td>\n<\/tr>\n
2-42<\/td>\n 85\u219257<\/td>\n 15\u219243<\/td>\n linear gradient<\/td>\n<\/tr>\n
42-57<\/td>\n 57\u21920<\/td>\n 43\u2192100<\/td>\n linear gradient<\/td>\n<\/tr>\n
57-60<\/td>\n 0<\/td>\n 100<\/td>\n isocratic<\/td>\n<\/tr>\n
60-61<\/td>\n 0\u219285<\/td>\n 100\u219215<\/td>\n linear gradient<\/td>\n<\/tr>\n
61-68<\/td>\n 85<\/td>\n 15<\/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 tigecycline (retention time about 20 minutes) are: impurity 1, about 0.5; impurity B, about 0.6; impurity A, about 0.7; impurity 2, about 1.3; impurity C, about 1.6; impurity 3, about 1.7.<\/p>\n
SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the peaks due to impurity B and impurity A is at least 1.5.<\/p>\n
LIMITS<\/h4>\n
In the chromatogram obtained with solution (1):<\/p>\n
the area of any peak corresponding to impurity A is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (2%);<\/p>\n
the area of any peak corresponding to impurity B is not greater than 0.7 times the area of the principal peak in the chromatogram obtained with solution (2) (0.7%);<\/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 (3) (0.2%);<\/p>\n
the area of any peak corresponding to impurity 2 is not greater than three times the area of the principal peak in the chromatogram obtained with solution (3) (0.3%);<\/p>\n
the area of any peak corresponding to impurity 1 or impurity 3 is not greater than half the area of the principal peak in the chromatogram obtained with solution (2) (0.5% of each);<\/p>\n
the area of any other secondary peak is not greater than twice the area of the principal peak in the chromatogram obtained with solution (3) (0.2%);<\/p>\n
the sum of the areas of any secondary peaks is not greater than four times the area of the principal peak in the chromatogram obtained with solution (2) (4%).<\/p>\n
Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (3) (0.1%).<\/p>\n
Water<\/h3>\n
Not more than 3.5%, Appendix IX C, Method III. Use the contents of one vial.<\/p>\n
ASSAY<\/h2>\n
Determine the weight of the contents of 10 containers as described in the test for uniformity of weight, Appendix XII C1, Powders for Parenteral Administration.<\/p>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in a solution of 0.44% w\/v of dipotassium hydrogen orthophosphate and 0.05% w\/v of sodium hydrogensulfite in water, adjusted to pH 8.0 with 1M potassium hydroxide. Store solutions at 10\u00b0 and protected from light.<\/p>\n
(1) Dissolve a quantity of the mixed contents of 10 containers to produce a solution containing 0.01% w\/v of Tigecycline.<\/p>\n
(2) 0.01% w\/v of tigecycline EPCRS.<\/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 (5 \u03bcm) (Prodigy ODS2 is suitable).<\/p>\n
(b) Use isocratic elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1.0 mL per minute.<\/p>\n
(d) Use a column temperature of 30\u00b0.<\/p>\n
(e) Use an autosampler temperature of 10\u00b0.<\/p>\n
(f) Use a detection wavelength of 248 nm.<\/p>\n
(g) Inject 20 \u03bcL of each solution.<\/p>\n
MOBILE PHASE<\/h4>\n
140 volumes of acetonitrile and 860 volumes of a solution of 0.44% w\/v of dipotassium hydrogen orthophosphate and 0.093% w\/v of disodium edetate in water, previously adjusted to pH 6.2 with orthophosphoric acid.<\/p>\n
DETERMINATION OF CONTENT<\/h4>\n
Calculate the content of tigecycline, C_{29<\/sub>H_{39<\/sub>N_{5<\/sub>O_{8<\/sub> in a container of average content weight from the chromatograms obtained, using the declared content of C_{29<\/sub>H_{39<\/sub>N_{5<\/sub>O_{8<\/sub> in tigecycline EPCRS.<\/p>\n}}}}}}}}
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include those listed under Tigecycline and the following:<\/p>\n
$\"Tigecycline$ <\/p>\n
1. (4S,4aS,12aS)-9-[(tert-Butylamino)acetamido]-4,7 bis(dimethylamino)-3,10,11,12a-tetrahydroxy-1,12-dioxo-1,4,4a,5,12,12a-hexahydrotetracene-2-carboxamide<\/p>\n
$\"Tigecycline$ <\/p>\n
2. 4-{[(2R)-6-[(tert-Butylamino)acetamido]-8-(dimethylamino)-5-hydroxy-4-oxo-1,2,3,4-tetrahydronaphthalen-2-yl]methyl}-2,5-dihydroxy-3,6-dioxocyclohexa-1,4-diene-1-carboxamide<\/p>\n
$\"Tigecycline$ <\/p>\n
3. (1S,4aR,4bR,10aR,11aS)-7-[(tert-Butylamino)acetamido]-9-(dimethyamino)-1,4,4a,6-tetrahydroxy-2,5,12-trioxo-1,2,4a,5,10,10a,11,11a-octahydro-1,4b-methanobenzo[b]fluorene-3-carboxamide<\/p>\n","protected":false},"excerpt":{"rendered":"
Action and use Glycylcycline antibacterial. DEFINITION Tigecycline for Infusion is a sterile material consisting of Tigecycline with or without excipients. It is supplied in a sealed container. The contents of the sealed container comply with the requirements for Powders for Injections or Infusions stated under Parenteral Preparations and with the following requirements. Content of tigecycline,…<\/p>\n","protected":false},"author":4,"featured_media":21476,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-21454","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\/21454","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=21454"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21454\/revisions"}],"predecessor-version":[{"id":21478,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21454\/revisions\/21478"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/21476"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=21454"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=21454"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=21454"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time (Minutes)\u00a0<\/strong><\/td>\n	Mobile phase A (% v\/v)\u00a0<\/strong><\/td>\n	Mobile phase B (% v\/v)\u00a0<\/strong><\/td>\n	Comment<\/strong><\/td>\n<\/tr>\n
0-2<\/td>\n	85<\/td>\n	15<\/td>\n	isocratic<\/td>\n<\/tr>\n
2-42<\/td>\n	85\u219257<\/td>\n	15\u219243<\/td>\n	linear gradient<\/td>\n<\/tr>\n
42-57<\/td>\n	57\u21920<\/td>\n	43\u2192100<\/td>\n	linear gradient<\/td>\n<\/tr>\n
57-60<\/td>\n	0<\/td>\n	100<\/td>\n	isocratic<\/td>\n<\/tr>\n
60-61<\/td>\n	0\u219285<\/td>\n	100\u219215<\/td>\n	linear gradient<\/td>\n<\/tr>\n
61-68<\/td>\n	85<\/td>\n	15<\/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 tigecycline (retention time about 20 minutes) are: impurity 1, about 0.5; impurity B, about 0.6; impurity A, about 0.7; impurity 2, about 1.3; impurity C, about 1.6; impurity 3, about 1.7.<\/p>\n SYSTEM SUITABILITY<\/h4>\n The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the peaks due to impurity B and impurity A is at least 1.5.<\/p>\n LIMITS<\/h4>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to impurity A is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (2%);<\/p>\n the area of any peak corresponding to impurity B is not greater than 0.7 times the area of the principal peak in the chromatogram obtained with solution (2) (0.7%);<\/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 (3) (0.2%);<\/p>\n the area of any peak corresponding to impurity 2 is not greater than three times the area of the principal peak in the chromatogram obtained with solution (3) (0.3%);<\/p>\n the area of any peak corresponding to impurity 1 or impurity 3 is not greater than half the area of the principal peak in the chromatogram obtained with solution (2) (0.5% of each);<\/p>\n the area of any other secondary peak is not greater than twice the area of the principal peak in the chromatogram obtained with solution (3) (0.2%);<\/p>\n the sum of the areas of any secondary peaks is not greater than four times the area of the principal peak in the chromatogram obtained with solution (2) (4%).<\/p>\n Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (3) (0.1%).<\/p>\n Water<\/h3>\n Not more than 3.5%, Appendix IX C, Method III. Use the contents of one vial.<\/p>\n ASSAY<\/h2>\n Determine the weight of the contents of 10 containers as described in the test for uniformity of weight, Appendix XII C1, Powders for Parenteral Administration.<\/p>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions in a solution of 0.44% w\/v of dipotassium hydrogen orthophosphate and 0.05% w\/v of sodium hydrogensulfite in water, adjusted to pH 8.0 with 1M potassium hydroxide. Store solutions at 10\u00b0 and protected from light.<\/p>\n (1) Dissolve a quantity of the mixed contents of 10 containers to produce a solution containing 0.01% w\/v of Tigecycline.<\/p>\n (2) 0.01% w\/v of tigecycline EPCRS.<\/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 (5 \u03bcm) (Prodigy ODS2 is suitable).<\/p>\n (b) Use isocratic elution and the mobile phase described below.<\/p>\n (c) Use a flow rate of 1.0 mL per minute.<\/p>\n (d) Use a column temperature of 30\u00b0.<\/p>\n (e) Use an autosampler temperature of 10\u00b0.<\/p>\n (f) Use a detection wavelength of 248 nm.<\/p>\n (g) Inject 20 \u03bcL of each solution.<\/p>\n MOBILE PHASE<\/h4>\n 140 volumes of acetonitrile and 860 volumes of a solution of 0.44% w\/v of dipotassium hydrogen orthophosphate and 0.093% w\/v of disodium edetate in water, previously adjusted to pH 6.2 with orthophosphoric acid.<\/p>\n DETERMINATION OF CONTENT<\/h4>\n Calculate the content of tigecycline, C_{29<\/sub>H_{39<\/sub>N_{5<\/sub>O_{8<\/sub> in a container of average content weight from the chromatograms obtained, using the declared content of C_{29<\/sub>H_{39<\/sub>N_{5<\/sub>O_{8<\/sub> in tigecycline EPCRS.<\/p>\n}}}}}}}} IMPURITIES<\/h2>\n The impurities limited by the requirements of this monograph include those listed under Tigecycline and the following:<\/p>\n $\"Tigecycline$ <\/p>\n 1. (4S,4aS,12aS)-9-[(tert-Butylamino)acetamido]-4,7 bis(dimethylamino)-3,10,11,12a-tetrahydroxy-1,12-dioxo-1,4,4a,5,12,12a-hexahydrotetracene-2-carboxamide<\/p>\n $\"Tigecycline$ <\/p>\n 2. 4-{[(2R)-6-[(tert-Butylamino)acetamido]-8-(dimethylamino)-5-hydroxy-4-oxo-1,2,3,4-tetrahydronaphthalen-2-yl]methyl}-2,5-dihydroxy-3,6-dioxocyclohexa-1,4-diene-1-carboxamide<\/p>\n $\"Tigecycline$ <\/p>\n 3. (1S,4aR,4bR,10aR,11aS)-7-[(tert-Butylamino)acetamido]-9-(dimethyamino)-1,4,4a,6-tetrahydroxy-2,5,12-trioxo-1,2,4a,5,10,10a,11,11a-octahydro-1,4b-methanobenzo[b]fluorene-3-carboxamide<\/p>\n","protected":false},"excerpt":{"rendered":" Action and use Glycylcycline antibacterial. DEFINITION Tigecycline for Infusion is a sterile material consisting of Tigecycline with or without excipients. It is supplied in a sealed container. The contents of the sealed container comply with the requirements for Powders for Injections or Infusions stated under Parenteral Preparations and with the following requirements. Content of tigecycline,…<\/p>\n","protected":false},"author":4,"featured_media":21476,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-21454","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\/21454","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=21454"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21454\/revisions"}],"predecessor-version":[{"id":21478,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/21454\/revisions\/21478"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/21476"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=21454"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=21454"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=21454"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

TESTS<\/h2>\n

Acidity<\/h3>\npH of a 1% w\/v solution, 5.0 to 6.5. Appendix V L.<\/p>\n

SYSTEM SUITABILITY<\/h4>\nThe test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the peaks due to impurity B and impurity A is at least 1.5.<\/p>\n

Water<\/h3>\nNot more than 3.5%, Appendix IX C, Method III. Use the contents of one vial.<\/p>\n

MOBILE PHASE<\/h4>\n140 volumes of acetonitrile and 860 volumes of a solution of 0.44% w\/v of dipotassium hydrogen orthophosphate and 0.093% w\/v of disodium edetate in water, previously adjusted to pH 6.2 with orthophosphoric acid.<\/p>\n

DETERMINATION OF CONTENT<\/h4>\nCalculate the content of tigecycline, C29<\/sub>H39<\/sub>N5<\/sub>O8<\/sub> in a container of average content weight from the chromatograms obtained, using the declared content of C29<\/sub>H39<\/sub>N5<\/sub>O8<\/sub> in tigecycline EPCRS.<\/p>\n

Acidity<\/h3>\n
pH of a 1% w\/v solution, 5.0 to 6.5. Appendix V L.<\/p>\n

SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the peaks due to impurity B and impurity A is at least 1.5.<\/p>\n

Water<\/h3>\n
Not more than 3.5%, Appendix IX C, Method III. Use the contents of one vial.<\/p>\n

MOBILE PHASE<\/h4>\n
140 volumes of acetonitrile and 860 volumes of a solution of 0.44% w\/v of dipotassium hydrogen orthophosphate and 0.093% w\/v of disodium edetate in water, previously adjusted to pH 6.2 with orthophosphoric acid.<\/p>\n