{"id":12728,"date":"2025-10-11T13:10:25","date_gmt":"2025-10-11T06:10:25","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=12728"},"modified":"2025-10-11T13:10:25","modified_gmt":"2025-10-11T06:10:25","slug":"desmopressin-nasal-spray","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/desmopressin-nasal-spray\/","title":{"rendered":"Desmopressin Nasal Spray"},"content":{"rendered":"

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

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

Vasopressin analogue; treatment of diabetes insipidus.<\/p>\n

DEFINITION<\/h2>\n
Desmopressin Nasal Spray is a solution of Desmopressin containing suitable buffering agents and preservatives in a suitable container.<\/p>\n
The nasal spray complies with the requirements stated under Nasal 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 5.5, 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) If necessary dilute a volume of the nasal spray in a solution of 0.9% w\/v of sodium chloride to produce a solution containing 0.01 to 0.015 % w\/v of the peptide.<\/p>\n
(2) Dissolve the contents of a vial of desmopressin impurity standard BPCRS in 1 mL of a solution of 0.9% w\/v sodium chloride.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/p>\n
(a) Use a stainless steel column (12 cm \u00d7 4.0 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (Nucleosil C18 is suitable).<\/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 100 \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 acetonitrile for chromatography<\/p>\n\n\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)\u00a0<\/strong><\/td>\n Comment<\/strong><\/td>\n<\/tr>\n
0-16<\/td>\n 83<\/td>\n 17<\/td>\n isocratic<\/td>\n<\/tr>\n
16-38<\/td>\n 83\u219272<\/td>\n 17\u219228<\/td>\n linear gragident<\/td>\n<\/tr>\n
38-46<\/td>\n 72<\/td>\n 28<\/td>\n isocratic<\/td>\n<\/tr>\n
46-50<\/td>\n 72\u219283<\/td>\n 28\u219217<\/td>\n linear gragident<\/td>\n<\/tr>\n
50-60<\/td>\n 83<\/td>\n 17<\/td>\n re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
SYSTEM SUITABILITY<\/p>\n
The test is not valid unless:<\/p>\n
in the chromatogram obtained with solution (2), the resolution between the two principal peaks is at least 2.0;<\/p>\n
the peak due to desmopressin is clearly separated from any peaks due to the excipients stated on the label.<\/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, any antimicrobial preservative stated on the label and any peak with an area less than 0.3%.<\/p>\n
ASSAY<\/h2>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) If necessary dilute a volume of the nasal spray in a solution of 0.9% w\/v of sodium chloride to give a final
\nconcentration in the range of 0.01 to 0.015 % w\/v of the peptide.<\/p>\n
(2) Dissolve the contents of a vial of desmopressin BPCRS in a solution of 0.9% sodium chloride to give a final concentration of 0.01% w\/v of the peptide.<\/p>\n
(3) Dissolve the contents of a vial of desmopressin impurity standard BPCRS in 1 mL of a solution of 0.9% w\/v sodium chloride.<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/p>\n
(a) Use a stainless steel column (12 cm \u00d7 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 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 100 \u03bcL of each solution.<\/p>\n
MOBILE PHASE<\/p>\n
17 volumes of acetonitrile and 83 volumes of 0.067M mixed phosphate buffer solution, pH 7.0.<\/p>\n
SYSTEM SUITABILITY<\/p>\n
The test is not valid unless:<\/p>\n
in the chromatogram obtained with solution (3), the resolution between the two principal peaks is at least 2.0;<\/p>\n
the peak due to desmopressin is clearly separated from any peaks due to the excipients stated on the label.<\/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 nasal spray 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 Nasal Spray should be protected from light and stored at a temperature of 2\u00b0 to 8\u00b0, unless otherwise justified and authorised.<\/p>\n
IMPURITIES<\/h2>\n
The impurities limited by the requirements of this monograph include those listed under Desmopressin.<\/p>\n","protected":false},"excerpt":{"rendered":"
(Ph. Eur. 11.6 update) Action and use Vasopressin analogue; treatment of diabetes insipidus. DEFINITION Desmopressin Nasal Spray is a solution of Desmopressin containing suitable buffering agents and preservatives in a suitable container. The nasal spray complies with the requirements stated under Nasal Preparations and with the following requirements. Content of desmopressin, C46H64N14O12S2 90.0 to 110.0%…<\/p>\n","protected":false},"author":4,"featured_media":12729,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-12728","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-volumes-1-2"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/12728","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=12728"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/12728\/revisions"}],"predecessor-version":[{"id":12732,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/12728\/revisions\/12732"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/12729"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=12728"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=12728"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=12728"}],"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)\u00a0<\/strong><\/td>\n	Comment<\/strong><\/td>\n<\/tr>\n
0-16<\/td>\n	83<\/td>\n	17<\/td>\n	isocratic<\/td>\n<\/tr>\n
16-38<\/td>\n	83\u219272<\/td>\n	17\u219228<\/td>\n	linear gragident<\/td>\n<\/tr>\n
38-46<\/td>\n	72<\/td>\n	28<\/td>\n	isocratic<\/td>\n<\/tr>\n
46-50<\/td>\n	72\u219283<\/td>\n	28\u219217<\/td>\n	linear gragident<\/td>\n<\/tr>\n
50-60<\/td>\n	83<\/td>\n	17<\/td>\n	re-equilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n SYSTEM SUITABILITY<\/p>\n The test is not valid unless:<\/p>\n in the chromatogram obtained with solution (2), the resolution between the two principal peaks is at least 2.0;<\/p>\n the peak due to desmopressin is clearly separated from any peaks due to the excipients stated on the label.<\/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, any antimicrobial preservative stated on the label and any peak with an area less than 0.3%.<\/p>\n ASSAY<\/h2>\n Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n (1) If necessary dilute a volume of the nasal spray in a solution of 0.9% w\/v of sodium chloride to give a final \nconcentration in the range of 0.01 to 0.015 % w\/v of the peptide.<\/p>\n (2) Dissolve the contents of a vial of desmopressin BPCRS in a solution of 0.9% sodium chloride to give a final concentration of 0.01% w\/v of the peptide.<\/p>\n (3) Dissolve the contents of a vial of desmopressin impurity standard BPCRS in 1 mL of a solution of 0.9% w\/v sodium chloride.<\/p>\n CHROMATOGRAPHIC CONDITIONS<\/p>\n (a) Use a stainless steel column (12 cm \u00d7 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 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 100 \u03bcL of each solution.<\/p>\n MOBILE PHASE<\/p>\n 17 volumes of acetonitrile and 83 volumes of 0.067M mixed phosphate buffer solution, pH 7.0.<\/p>\n SYSTEM SUITABILITY<\/p>\n The test is not valid unless:<\/p>\n in the chromatogram obtained with solution (3), the resolution between the two principal peaks is at least 2.0;<\/p>\n the peak due to desmopressin is clearly separated from any peaks due to the excipients stated on the label.<\/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 nasal spray 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 Nasal Spray should be protected from light and stored at a temperature of 2\u00b0 to 8\u00b0, unless otherwise justified and authorised.<\/p>\n IMPURITIES<\/h2>\n The impurities limited by the requirements of this monograph include those listed under Desmopressin.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. 11.6 update) Action and use Vasopressin analogue; treatment of diabetes insipidus. DEFINITION Desmopressin Nasal Spray is a solution of Desmopressin containing suitable buffering agents and preservatives in a suitable container. The nasal spray complies with the requirements stated under Nasal Preparations and with the following requirements. Content of desmopressin, C46H64N14O12S2 90.0 to 110.0%…<\/p>\n","protected":false},"author":4,"featured_media":12729,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-12728","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-volumes-1-2"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/12728","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=12728"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/12728\/revisions"}],"predecessor-version":[{"id":12732,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/12728\/revisions\/12732"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/12729"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=12728"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=12728"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=12728"}],"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

STORAGE<\/h2>\nDesmopressin Nasal Spray should be protected from light and stored at a temperature of 2\u00b0 to 8\u00b0, unless otherwise justified and authorised.<\/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

STORAGE<\/h2>\n
Desmopressin Nasal Spray should be protected from light and stored at a temperature of 2\u00b0 to 8\u00b0, unless otherwise justified and authorised.<\/p>\n