{"id":16382,"date":"2025-10-20T14:54:27","date_gmt":"2025-10-20T07:54:27","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=16382"},"modified":"2025-10-20T17:05:09","modified_gmt":"2025-10-20T10:05:09","slug":"erythromycin-lactobionate-for-infusion","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/erythromycin-lactobionate-for-infusion\/","title":{"rendered":"Erythromycin Lactobionate for Infusion"},"content":{"rendered":"

(Ph. Eur. 11.6 update)<\/p>\n

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

Macrolide antibacterial.<\/p>\n

DEFINITION<\/h2>\n
Erythromycin Lactobionate for Infusion is a sterile material consisting of Erythromycin Lactobionate 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 Parenteral Preparations and with the following requirements.<\/p>\n
Content of erythromycins, calculated as the sum of erythromycin A (C_{37<\/sub>H_{67<\/sub>NO_{13<\/sub>), erythromycin B (C_{37<\/sub>H_{67<\/sub>NO_{12<\/sub>) and erythromycin C (C_{36<\/sub>H_{65<\/sub>NO_{13<\/sub>)<\/strong><\/p>\n}}}}}}}}}
95.0 to 110.0% of the stated amount of erythromycin.<\/p>\n
IDENTIFICATION<\/h2>\n
The infrared absorption spectrum, Appendix II A, of the dry powder, is concordant with the reference spectrum of erythromycin lactobionate (RS 126).<\/p>\n
TESTS<\/h2>\n
Acidity or alkalinity<\/h3>\n
pH of a solution containing the equivalent of 1.34% w\/v of erythromycin, 6.5 to 7.5, Appendix V L.<\/p>\n
Related substances<\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in solution A. Prepare the solutions immediately before use and protect from light.<\/p>\n
Solution A 40 volumes of a 1.15% w\/v solution of dipotassium hydrogen orthophosphate adjusted to pH 8.0 using dilute phosphoric acid and 60 volumes of methanol R1.<\/p>\n
(1) Dissolve a quantity of the contents of a sealed container to produce a solution containing the equivalent of 0.4% w\/v erythromycin.<\/p>\n
(2) Dilute 1 volume of solution (1) to 100 volumes.<\/p>\n
(3) 0.4% w\/v of erythromycin for system suitability EPCRS.<\/p>\n
(4) Dilute 1 volume of solution (2) to 5 volumes.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with end-capped polar-embedded octadecylsilyl amorphous organosilica polymer (3.5 \u03bcm) (X-Terra RP18 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 65\u00b0.<\/p>\n
(e) Use a detection wavelength of 210 nm.<\/p>\n
(f) Inject 100 \u03bcL of each solution.<\/p>\n
MOBILE PHASE<\/h4>\n
Mobile phase A 5 volumes of a 3.5% w\/v solution of dipotassium hydrogen orthophosphate previously adjusted to pH 7.0 using dilute phosphoric acid, 35 volumes of acetonitrile R1 and 60 volumes of water.<\/p>\n
Mobile phase B 5 volumes of a 3.5% w\/v solution of dipotassium hydrogen orthophosphate previously adjusted to pH 7.0 using dilute phosphoric acid, 50 volumes of acetonitrile R1 and 45 volumes of water.<\/p>\n\n\n\n\n\n\n\n\n
Time (Minutes)<\/td>\n Mobile phase A (% v\/v)<\/td>\n Mobile phase B (% v\/v)<\/td>\n Comment<\/td>\n<\/tr>\n
0-44<\/td>\n 100<\/td>\n 0<\/td>\n isocratic<\/td>\n<\/tr>\n
44-46<\/td>\n 100\u21920<\/td>\n 0\u2192100<\/td>\n linear gradient<\/td>\n<\/tr>\n
46-61<\/td>\n 0<\/td>\n 100<\/td>\n isocratic<\/td>\n<\/tr>\n
61-63<\/td>\n 0\u2192100<\/td>\n 100\u21920<\/td>\n linear gradient<\/td>\n<\/tr>\n
63-80<\/td>\n 100<\/td>\n 0<\/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 erythromycin A (retention time about 23 minutes) are: impurity A, about 0.4; impurity B, about 0.5; erythromycin C, about 0.55; impurity L, about 0.63; impurity C, about 0.9; impurity D, about 1.6; erythromycin B, about 1.75; impurity F, about 1.8 and impurity E, about 2.3.<\/p>\n
SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (3):<\/p>\n
the resolution between the peaks due to impurity B and erythromycin C is at least 1.2;<\/p>\n
the peak-to-valley ratio is at least 2.0, where Hp is the height above the baseline of the peak due to impurity C and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to erythromycin A;<\/p>\n
the peak-to-valley ratio is at least 1.5, where Hp is the height above the baseline of the peak due to impurity F and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to erythromycin B.<\/p>\n
LIMITS<\/h4>\n
Identify any peaks corresponding to impurities D, E, F and L in the chromatogram obtained with solution (1), using the chromatogram obtained with solution (3), and multiply the areas of these peaks by the corresponding correction factors: impurity D, 2.0; impurity E, 0.08; impurity F, 0.08; impurity L, 0.11.<\/p>\n
In the chromatogram obtained with solution (1):<\/p>\n
the area of any peak corresponding to impurity C is not greater than 3 times the area of the principal peak in the chromatogram obtained with solution (2) (3%);<\/p>\n
the area of any peak corresponding to impurity A or B is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (2% of each);<\/p>\n
the area of any peak corresponding to impurity D, E or F is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1% of each);<\/p>\n
the area of any peak corresponding to impurity L is not greater than 0.4 times the area of the principal peak in the chromatogram obtained with solution (2) (0.4%);<\/p>\n
the area of any other secondary peak, other than the peaks due to erythromycin B and C is not greater than 0.4 times the area of the principal peak in the chromatogram obtained with solution (2) (0.4%);<\/p>\n
the sum of the areas of any secondary peaks, other than the peaks due to erythromycin B and C is not greater than 7 times the area of the principal peak in the chromatogram obtained with solution (2) (7%).<\/p>\n
Disregard any peak due to erythromycin B and erythromycin C and any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.2%).<\/p>\n
The content of each of erythromycin B and erythromycin C, as determined under Assay, is not more than 5%.<\/p>\n
ASSAY<\/h2>\n
Determine the weight of the contents of 10 sealed 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 solution A. Prepare the solutions immediately before use and protect from light.<\/p>\n
Solution A 40 volumes of a 1.15% w\/v solution of dipotassium hydrogen orthophosphate adjusted to pH 8.0 using dilute phosphoric acid and 60 volumes of methanol R1.<\/p>\n
(1) Dilute a quantity of the mixed contents of sealed containers to produce a solution containing the equivalent of 0.4% w\/v of Erythromycin.<\/p>\n
(2) 0.4% w\/v of erythromycin BPCRS.<\/p>\n
(3) 0.4% w\/v of erythromycin for system suitability EPCRS.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/h4>\n
The chromatographic conditions described under Related substances may be used.<\/p>\n
SYSTEM SUITABILITY<\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (3):<\/p>\n
the resolution between the peaks due to impurity B and erythromycin C is at least 1.2;<\/p>\n
the peak-to-valley ratio is at least 2.0, where Hp is the height above the baseline of the peak due to impurity C and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to erythromycin A;<\/p>\n
the peak-to-valley ratio is at least 1.5, where Hp is the height above the baseline of the peak due to impurity F and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to erythromycin B.<\/p>\n
DETERMINATION OF CONTENT<\/h4>\n
Calculate the percentage content of erythromycin A (C_{37<\/sub>H_{67<\/sub>NO_{13<\/sub>), erythromycin B (C_{37<\/sub>H_{67<\/sub>NO_{12<\/sub>) and erythromycin C (C_{36<\/sub>H_{65<\/sub>NO_{13<\/sub>) using the chromatograms obtained with solutions (1) and (2) and the declared contents of C_{37<\/sub>H_{67<\/sub>NO_{13<\/sub>, C_{37<\/sub>H_{67<\/sub>NO_{12<\/sub> and C_{36<\/sub>H_{65<\/sub>NO_{13<\/sub> respectively in erythromycin BPCRS.<\/p>\n}}}}}}}}}}}}}}}}}}
LABELLING<\/h2>\n
The label of the sealed container states the quantity of active ingredient contained in it in terms of the equivalent amount of erythromycin.<\/p>\n
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include those listed under Erythromycin Lactobionate.<\/p>\n","protected":false},"excerpt":{"rendered":"
(Ph. Eur. 11.6 update) Action and use Macrolide antibacterial. DEFINITION Erythromycin Lactobionate for Infusion is a sterile material consisting of Erythromycin Lactobionate 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…<\/p>\n","protected":false},"author":5,"featured_media":16496,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-16382","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\/16382","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=16382"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16382\/revisions"}],"predecessor-version":[{"id":16396,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16382\/revisions\/16396"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/16496"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=16382"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=16382"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=16382"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time (Minutes)<\/td>\n	Mobile phase A (% v\/v)<\/td>\n	Mobile phase B (% v\/v)<\/td>\n	Comment<\/td>\n<\/tr>\n
0-44<\/td>\n	100<\/td>\n	0<\/td>\n	isocratic<\/td>\n<\/tr>\n
44-46<\/td>\n	100\u21920<\/td>\n	0\u2192100<\/td>\n	linear gradient<\/td>\n<\/tr>\n
46-61<\/td>\n	0<\/td>\n	100<\/td>\n	isocratic<\/td>\n<\/tr>\n
61-63<\/td>\n	0\u2192100<\/td>\n	100\u21920<\/td>\n	linear gradient<\/td>\n<\/tr>\n
63-80<\/td>\n	100<\/td>\n	0<\/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 erythromycin A (retention time about 23 minutes) are: impurity A, about 0.4; impurity B, about 0.5; erythromycin C, about 0.55; impurity L, about 0.63; impurity C, about 0.9; impurity D, about 1.6; erythromycin B, about 1.75; impurity F, about 1.8 and impurity E, about 2.3.<\/p>\n SYSTEM SUITABILITY<\/h4>\n The test is not valid unless, in the chromatogram obtained with solution (3):<\/p>\n the resolution between the peaks due to impurity B and erythromycin C is at least 1.2;<\/p>\n the peak-to-valley ratio is at least 2.0, where Hp is the height above the baseline of the peak due to impurity C and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to erythromycin A;<\/p>\n the peak-to-valley ratio is at least 1.5, where Hp is the height above the baseline of the peak due to impurity F and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to erythromycin B.<\/p>\n LIMITS<\/h4>\n Identify any peaks corresponding to impurities D, E, F and L in the chromatogram obtained with solution (1), using the chromatogram obtained with solution (3), and multiply the areas of these peaks by the corresponding correction factors: impurity D, 2.0; impurity E, 0.08; impurity F, 0.08; impurity L, 0.11.<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any peak corresponding to impurity C is not greater than 3 times the area of the principal peak in the chromatogram obtained with solution (2) (3%);<\/p>\n the area of any peak corresponding to impurity A or B is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (2% of each);<\/p>\n the area of any peak corresponding to impurity D, E or F is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1% of each);<\/p>\n the area of any peak corresponding to impurity L is not greater than 0.4 times the area of the principal peak in the chromatogram obtained with solution (2) (0.4%);<\/p>\n the area of any other secondary peak, other than the peaks due to erythromycin B and C is not greater than 0.4 times the area of the principal peak in the chromatogram obtained with solution (2) (0.4%);<\/p>\n the sum of the areas of any secondary peaks, other than the peaks due to erythromycin B and C is not greater than 7 times the area of the principal peak in the chromatogram obtained with solution (2) (7%).<\/p>\n Disregard any peak due to erythromycin B and erythromycin C and any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.2%).<\/p>\n The content of each of erythromycin B and erythromycin C, as determined under Assay, is not more than 5%.<\/p>\n ASSAY<\/h2>\n Determine the weight of the contents of 10 sealed 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 solution A. Prepare the solutions immediately before use and protect from light.<\/p>\n Solution A 40 volumes of a 1.15% w\/v solution of dipotassium hydrogen orthophosphate adjusted to pH 8.0 using dilute phosphoric acid and 60 volumes of methanol R1.<\/p>\n (1) Dilute a quantity of the mixed contents of sealed containers to produce a solution containing the equivalent of 0.4% w\/v of Erythromycin.<\/p>\n (2) 0.4% w\/v of erythromycin BPCRS.<\/p>\n (3) 0.4% w\/v of erythromycin for system suitability EPCRS.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/h4>\n The chromatographic conditions described under Related substances may be used.<\/p>\n SYSTEM SUITABILITY<\/h4>\n The test is not valid unless, in the chromatogram obtained with solution (3):<\/p>\n the resolution between the peaks due to impurity B and erythromycin C is at least 1.2;<\/p>\n the peak-to-valley ratio is at least 2.0, where Hp is the height above the baseline of the peak due to impurity C and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to erythromycin A;<\/p>\n the peak-to-valley ratio is at least 1.5, where Hp is the height above the baseline of the peak due to impurity F and Hv is the height above the baseline of the lowest point of the curve separating this peak from the peak due to erythromycin B.<\/p>\n DETERMINATION OF CONTENT<\/h4>\n Calculate the percentage content of erythromycin A (C_{37<\/sub>H_{67<\/sub>NO_{13<\/sub>), erythromycin B (C_{37<\/sub>H_{67<\/sub>NO_{12<\/sub>) and erythromycin C (C_{36<\/sub>H_{65<\/sub>NO_{13<\/sub>) using the chromatograms obtained with solutions (1) and (2) and the declared contents of C_{37<\/sub>H_{67<\/sub>NO_{13<\/sub>, C_{37<\/sub>H_{67<\/sub>NO_{12<\/sub> and C_{36<\/sub>H_{65<\/sub>NO_{13<\/sub> respectively in erythromycin BPCRS.<\/p>\n}}}}}}}}}}}}}}}}}} LABELLING<\/h2>\n The label of the sealed container states the quantity of active ingredient contained in it in terms of the equivalent amount of erythromycin.<\/p>\n IMPURITIES<\/h2>\n The impurities limited by the requirements of this monograph include those listed under Erythromycin Lactobionate.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. 11.6 update) Action and use Macrolide antibacterial. DEFINITION Erythromycin Lactobionate for Infusion is a sterile material consisting of Erythromycin Lactobionate 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…<\/p>\n","protected":false},"author":5,"featured_media":16496,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-16382","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\/16382","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=16382"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16382\/revisions"}],"predecessor-version":[{"id":16396,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/16382\/revisions\/16396"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/16496"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=16382"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=16382"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=16382"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

TESTS<\/h2>\n

Acidity or alkalinity<\/h3>\npH of a solution containing the equivalent of 1.34% w\/v of erythromycin, 6.5 to 7.5, Appendix V L.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h4>\nThe chromatographic conditions described under Related substances may be used.<\/p>\n

LABELLING<\/h2>\nThe label of the sealed container states the quantity of active ingredient contained in it in terms of the equivalent amount of erythromycin.<\/p>\n

Acidity or alkalinity<\/h3>\n
pH of a solution containing the equivalent of 1.34% w\/v of erythromycin, 6.5 to 7.5, Appendix V L.<\/p>\n

CHROMATOGRAPHIC CONDITIONS<\/h4>\n
The chromatographic conditions described under Related substances may be used.<\/p>\n

LABELLING<\/h2>\n
The label of the sealed container states the quantity of active ingredient contained in it in terms of the equivalent amount of erythromycin.<\/p>\n