{"id":10979,"date":"2025-10-09T06:14:45","date_gmt":"2025-10-08T23:14:45","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=10979"},"modified":"2025-10-09T11:07:51","modified_gmt":"2025-10-09T04:07:51","slug":"desmopressin-injection","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/desmopressin-injection\/","title":{"rendered":"Desmopressin Injection"},"content":{"rendered":"

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

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

Vasopressin analogue; treatment of diabetes insipidus; nocturnal enuresis; haemophillia; von Willebrand\u2019s disease.<\/p>\n

DEFINITION<\/h2>\n
Desmopressin Injection is a sterile solution of Desmopressin in Water for Injections.<\/p>\n
The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.<\/p>\n
Content of desmopressin, C_{46<\/sub>H_{64<\/sub>N_{14<\/sub>O_{12<\/sub>S_{2<\/sub><\/strong><\/p>\n}}}}}
90.0 to 110.0% of the stated amount of the peptide.<\/p>\n
CHARACTERISTICS<\/h2>\n
A colourless solution.<\/p>\n
IDENTIFICATION<\/h2>\n
In the Assay, the principal peak in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).<\/p>\n
TESTS<\/h2>\n
Acidity<\/strong><\/p>\n
pH, 3.5 to 6.0, Appendix V L.<\/p>\n
Related substances<\/strong><\/p>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions and the normalisation procedure.<\/p>\n
(1) Dilute the injection, if necessary, with water to produce a solution containing 0.0004% w\/v of the peptide.<\/p>\n
(2) Dissolve the contents of a vial of desmopressin impurity standard BPCRS in 2 mL of water.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/p>\n
(a) Use a stainless steel column (12 cm x 4.0 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm).<\/p>\n
(b) Use gradient elution and the mobile phase described below.<\/p>\n
(c) Use a flow rate of 1.5 mL per minute.<\/p>\n
(d) Use an ambient column temperature.<\/p>\n
(e) Use a detection wavelength of 220 nm.<\/p>\n
(f) Inject 200 \u03bcL of each solution.<\/p>\n
MOBILE PHASE<\/p>\n
Mobile phase A 0.067M mixed phosphate buffer solution pH 7.0.<\/p>\n
Mobile phase B A mixture of acetonitrile for chromatography and mobile phase A in equal volumes.<\/p>\n\n\n\n\n\n\n\n\n
Time (Minutes)<\/strong><\/td>\n Mobile phase A%<\/strong><\/td>\n Mobile phase B%<\/strong><\/td>\n Comment<\/strong><\/td>\n<\/tr>\n
0-4<\/td>\n 76<\/td>\n 24<\/td>\n isocratic<\/td>\n<\/tr>\n
4-18<\/td>\n 76\u219258<\/td>\n 24\u219242<\/td>\n linear gragident<\/td>\n<\/tr>\n
18-35<\/td>\n 58\u219248<\/td>\n 42\u219252<\/td>\n linear gragident<\/td>\n<\/tr>\n
35-40<\/td>\n 48\u219276<\/td>\n 52\u219224<\/td>\n linear gragident<\/td>\n<\/tr>\n
40-50<\/td>\n 76<\/td>\n 24<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
The retention time of [4- L -glutamic acid]desmopressin is about 14 minutes and the retention time of desmopressin is about 15 minutes.<\/p>\n
SYSTEM SUITABILITY<\/p>\n
The test is not valid unless, in the chromatogram obtained with solution (2), the resolution between the two principal peaks is at least 3.4.<\/p>\n
LIMITS<\/p>\n
In the chromatogram obtained with solution (1):<\/p>\n
the area of any secondary peak is not more than 4.0%;<\/p>\n
the total area of any such peaks is not more than 5.0%.<\/p>\n
Disregard any peak due to the solvent or with an area less than 2.0%.<\/p>\n
Bacterial endotoxins<\/p>\n
Carry out the test for bacterial endotoxins, Appendix XIV C. The endotoxin limit concentration is less than 10 IU per \u03bcg peptide.<\/p>\n
ASSAY<\/h2>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) Dilute a volume of the injection in water to give a final concentration of 0.0004 % w\/v of the peptide.<\/p>\n
(2) 0.0004% w\/v of desmopressin BPCRS in water.<\/p>\n
(3) Dissolve the contents of a vial of desmopressin impurity standard BPCRS in 2 mL of water.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/p>\n
(a) Use a stainless steel column (12 cm x 4.0 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (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 an ambient column temperature.<\/p>\n
(e) Use a detection wavelength of 220 nm.<\/p>\n
(f) Inject 200 \u03bcL of each solution.<\/p>\n
MOBILE PHASE<\/p>\n
20 volumes of acetonitrile for chromatography and 80 volumes of 0.067 M mixed phosphate buffer solution, pH 7.0.<\/p>\n
The retention time of desmopressin is about 5 minutes; if necessary adjust the concentration of acetonitrile in the mobile phase to obtain a retention time of about 5 minutes.<\/p>\n
SYSTEM SUITABILITY
\nThe test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the two principal peaks at least 2.8.<\/p>\n
DETERMINATION OF CONTENT<\/p>\n
Calculate the content of C_{46<\/sub>H_{64<\/sub>N_{14<\/sub>O_{12<\/sub>S_{2<\/sub> in the injection from the chromatograms obtained and from the declared content of C_{46<\/sub>H_{64<\/sub>N_{14<\/sub>O_{12<\/sub>S_{2 <\/sub>in desmopressin BPCRS.<\/p>\n}}}}}}}}}}
STORAGE<\/h2>\n
Desmopressin Injection should be protected from light and stored at a temperature of 2\u00b0 to 8\u00b0.<\/p>\n","protected":false},"excerpt":{"rendered":"
(Ph. Eur. 11.6 update) Action and use Vasopressin analogue; treatment of diabetes insipidus; nocturnal enuresis; haemophillia; von Willebrand\u2019s disease. DEFINITION Desmopressin Injection is a sterile solution of Desmopressin in Water for Injections. The injection complies with the requirements stated under Parenteral Preparations and with the following requirements. Content of desmopressin, C46H64N14O12S2 90.0 to 110.0% of…<\/p>\n","protected":false},"author":4,"featured_media":10981,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-10979","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\/10979","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=10979"}],"version-history":[{"count":5,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/10979\/revisions"}],"predecessor-version":[{"id":11234,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/10979\/revisions\/11234"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/10981"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=10979"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=10979"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=10979"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time (Minutes)<\/strong><\/td>\n	Mobile phase A%<\/strong><\/td>\n	Mobile phase B%<\/strong><\/td>\n	Comment<\/strong><\/td>\n<\/tr>\n
0-4<\/td>\n	76<\/td>\n	24<\/td>\n	isocratic<\/td>\n<\/tr>\n
4-18<\/td>\n	76\u219258<\/td>\n	24\u219242<\/td>\n	linear gragident<\/td>\n<\/tr>\n
18-35<\/td>\n	58\u219248<\/td>\n	42\u219252<\/td>\n	linear gragident<\/td>\n<\/tr>\n
35-40<\/td>\n	48\u219276<\/td>\n	52\u219224<\/td>\n	linear gragident<\/td>\n<\/tr>\n
40-50<\/td>\n	76<\/td>\n	24<\/td>\n	re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n The retention time of [4- L -glutamic acid]desmopressin is about 14 minutes and the retention time of desmopressin is about 15 minutes.<\/p>\n SYSTEM SUITABILITY<\/p>\n The test is not valid unless, in the chromatogram obtained with solution (2), the resolution between the two principal peaks is at least 3.4.<\/p>\n LIMITS<\/p>\n In the chromatogram obtained with solution (1):<\/p>\n the area of any secondary peak is not more than 4.0%;<\/p>\n the total area of any such peaks is not more than 5.0%.<\/p>\n Disregard any peak due to the solvent or with an area less than 2.0%.<\/p>\n Bacterial endotoxins<\/p>\n Carry out the test for bacterial endotoxins, Appendix XIV C. The endotoxin limit concentration is less than 10 IU per \u03bcg peptide.<\/p>\n ASSAY<\/h2>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) Dilute a volume of the injection in water to give a final concentration of 0.0004 % w\/v of the peptide.<\/p>\n (2) 0.0004% w\/v of desmopressin BPCRS in water.<\/p>\n (3) Dissolve the contents of a vial of desmopressin impurity standard BPCRS in 2 mL of water.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n (a) Use a stainless steel column (12 cm x 4.0 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (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 an ambient column temperature.<\/p>\n (e) Use a detection wavelength of 220 nm.<\/p>\n (f) Inject 200 \u03bcL of each solution.<\/p>\n MOBILE PHASE<\/p>\n 20 volumes of acetonitrile for chromatography and 80 volumes of 0.067 M mixed phosphate buffer solution, pH 7.0.<\/p>\n The retention time of desmopressin is about 5 minutes; if necessary adjust the concentration of acetonitrile in the mobile phase to obtain a retention time of about 5 minutes.<\/p>\n SYSTEM SUITABILITY \nThe test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the two principal peaks at least 2.8.<\/p>\n DETERMINATION OF CONTENT<\/p>\n Calculate the content of C_{46<\/sub>H_{64<\/sub>N_{14<\/sub>O_{12<\/sub>S_{2<\/sub> in the injection from the chromatograms obtained and from the declared content of C_{46<\/sub>H_{64<\/sub>N_{14<\/sub>O_{12<\/sub>S_{2 <\/sub>in desmopressin BPCRS.<\/p>\n}}}}}}}}}} STORAGE<\/h2>\n Desmopressin Injection should be protected from light and stored at a temperature of 2\u00b0 to 8\u00b0.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. 11.6 update) Action and use Vasopressin analogue; treatment of diabetes insipidus; nocturnal enuresis; haemophillia; von Willebrand\u2019s disease. DEFINITION Desmopressin Injection is a sterile solution of Desmopressin in Water for Injections. The injection complies with the requirements stated under Parenteral Preparations and with the following requirements. Content of desmopressin, C46H64N14O12S2 90.0 to 110.0% of…<\/p>\n","protected":false},"author":4,"featured_media":10981,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-10979","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\/10979","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=10979"}],"version-history":[{"count":5,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/10979\/revisions"}],"predecessor-version":[{"id":11234,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/10979\/revisions\/11234"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/10981"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=10979"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=10979"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=10979"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

IDENTIFICATION<\/h2>\nIn the Assay, the principal peak in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).<\/p>\n

IDENTIFICATION<\/h2>\n
In the Assay, the principal peak in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).<\/p>\n