{"id":9579,"date":"2025-10-06T16:05:03","date_gmt":"2025-10-06T09:05:03","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=9579"},"modified":"2025-10-06T16:08:37","modified_gmt":"2025-10-06T09:08:37","slug":"calcitonin-salmon-injection","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/calcitonin-salmon-injection\/","title":{"rendered":"Calcitonin (Salmon) Injection"},"content":{"rendered":"

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

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

Hormone.<\/p>\n

DEFINITION<\/h2>\n
Calcitonin (Salmon) Injection is a sterile solution of Calcitonin (Salmon) 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 calcitonin (salmon), C_{145<\/sub>H_{240<\/sub>N_{44<\/sub>O_{48<\/sub>S_{2<\/sub><\/strong><\/p>\n}}}}}
90.0 to 115.0% of the stated amount of the peptide.<\/p>\n
CHARACTERISTICS<\/h2>\n
A colourless solution.<\/p>\n
IDENTIFICATION<\/h2>\n
In the Assay, the retention time of the principal peak in the chromatogram obtained with solution (1) is similar to that of the principal peak in the chromatogram obtained with solution (2).<\/p>\n
TESTS<\/h2>\n
Acidity<\/strong><\/p>\n
pH, 3.9 to 4.5, Appendix V L.<\/p>\n
Calcitonin C<\/strong><\/p>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) Dilute the injection, if necessary, with a 0.1M solution of sodium dihydrogen orthophosphate adjusted to pH 4.0 with orthophosphoric acid to give a final concentration of 10 \u03bcg of calcitonin (salmon) per mL.<\/p>\n
(2) 10 \u03bcg of calcitonin (salmon) EPCRS per mL in a 0.1M solution of sodium dihydrogen orthophosphate adjusted to pH 4.0 with orthophosphoric acid.<\/p>\n
(3) Heat the injection at 75\u00b0 for 15 hours and, if necessary, dilute as described for solution (1).<\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/p>\n
(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm) (Vydac C18, 300 \u00c5 wide pore column for proteins and peptides is suitable).<\/p>\n
(b) Use gradient elution and the mobile phases described below.<\/p>\n
(c) Use a flow rate of 1 mL per minute.<\/p>\n
(d) Use a column temperature of 40\u00b0.<\/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 100 volumes of a 0.363% w\/v solution of tetramethylammonium hydroxide pentahydrate and 150 volumes of acetonitrile adjusted to pH 2.5 with orthophosphoric acid.<\/p>\n
Mobile phase B 50 volumes of acetonitrile and 450 volumes of a 0.402% w\/v solution of tetramethyl-ammonium hydroxide pentahydrate adjusted to pH 2.5 with orthophosphoric acid.<\/p>\n
Use the following gradient.<\/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
0-21<\/td>\n 35 \u2192 57<\/td>\n 65 \u2192 43<\/td>\n linear gradient<\/td>\n<\/tr>\n
21-22<\/td>\n 57 \u2192 35<\/td>\n 43 \u2192 65<\/td>\n linear gradient<\/td>\n<\/tr>\n
22-30<\/td>\n 35<\/td>\n 65<\/td>\n re-quilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
In the chromatogram obtained with solution (3) the peak due to calcitonin C is the largest peak to elute after the injection buffer salts and before the principal peak with a relative retention to that of calcitonin (salmon) of between 0.5 and 0.6.<\/p>\n
SYSTEM SUITABILITY<\/p>\n
The test is not valid unless the resolution factor between the peaks due to calcitonin C and calcitonin (salmon) in the chromatogram obtained with solution (3) is at least 3.0.<\/p>\n
LIMITS<\/p>\n
In the chromatogram obtained with solution (1) the area of any peak corresponding to calcitonin C is not greater than 7% by normalisation.<\/p>\n
Related peptides<\/strong><\/p>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n
(1) Dilute the injection, if necessary, with mobile phase A to give a final concentration of 10 \u03bcg of calcitonin (salmon) per mL.<\/p>\n
(2) Dissolve the contents of a vial of N-acetyl-cys^{1<\/sup> calcitonin EPCRS in 0.4 mL of mobile phase A, dilute to 40 mL with mobile phase A and add 0.1 mL of solution (1).<\/p>\n}
CHROMATOGRAPHIC CONDITIONS<\/p>\n
(a) Use a stainless steel column (25 cm \u00d7 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 \u03bcm).<\/p>\n
(b) Use gradient elution and the mobile phases described below.<\/p>\n
(c) Use a flow rate of 1 mL per minute.<\/p>\n
(d) Use a column temperature of 65\u00b0.<\/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 Dissolve 3.26 g of tetramethylammonium hydroxide pentahydrate in 900 mL of water, adjust the pH to 2.5 with orthophosphoric acid and mix with 100 mL of acetonitrile for chromatography.<\/p>\n
Mobile phase B Dissolve 1.45 g of tetramethylammonium hydroxide pentahydrate in 400 mL of water, adjust the pH to 2.5 with orthophosphoric acid and mix with 600 mL of acetonitrile for chromatography.<\/p>\n
Use the following gradient.<\/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
0-30<\/td>\n 72 \u2192 48<\/td>\n 28 \u2192 52<\/td>\n linear gradient<\/td>\n<\/tr>\n
30-32<\/td>\n 48 \u2192 72<\/td>\n 52 \u2192 28<\/td>\n linear gradient<\/td>\n<\/tr>\n
32-55<\/td>\n 72<\/td>\n 28<\/td>\n re-quilibration<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
When the chromatogram for solution (2) is recorded in the prescribed conditions, the relative retention time of N-acetyl-cys^{1<\/sup> calcitonin is about 1.15 relative to the principal peak.<\/p>\n}
SYSTEM SUITABILITY<\/p>\n
The test is not valid unless the resolution factor between the peaks corresponding to calcitonin and N-acetyl-cys calcitonin is at least 5.0 and the symmetry factor for the N-acetyl-cys^{1<\/sup> calcitonin peak is not greater than 2.5. If necessary, adjust the initial ratio of A:B in the mobile phase.<\/p>\n}
LIMITS<\/p>\n
In the chromatogram obtained with solution (1):<\/p>\n
the area of any secondary peak is not greater than 3% of the total area of all the peaks;<\/p>\n
the sum of the areas of any such peaks is not greater than 5% of the total area of all the peaks by normalisation;<\/p>\n
disregard any peak with an area less than 0.1 % of that of the principal peak.<\/p>\n
ASSAY<\/h2>\n
Carry out the method described under the test for Calcitonin C.<\/p>\n
Calculate the content of calcitonin (salmon) from the areas of the peak due to calcitonin (salmon) and that of any peak due to calcitonin C, using the declared content of C_{145<\/sub>H_{240<\/sub>N_{44<\/sub>O_{48<\/sub>S_{2 <\/sub>in calcitonin (salmon) EPCRS.<\/p>\n}}}}}
STORAGE<\/h2>\n
Calcitonin (Salmon) Injection should be protected from light and stored at a temperature of 2\u00b0 to 8\u00b0.<\/p>\n
LABELLING<\/h2>\n
The label states the strength as the number of IU (Units) per mL. The label also states the equivalent number of micrograms of the peptide per mL.<\/p>\n","protected":false},"excerpt":{"rendered":"
(Ph. Eur. 11.6 update) Action and use Hormone. DEFINITION Calcitonin (Salmon) Injection is a sterile solution of Calcitonin (Salmon) in Water for Injections. The injection complies with the requirements stated under Parenteral Preparations and with the following requirements. Content of calcitonin (salmon), C145H240N44O48S2 90.0 to 115.0% of the stated amount of the peptide. CHARACTERISTICS A…<\/p>\n","protected":false},"author":4,"featured_media":9587,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-9579","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\/9579","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=9579"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/9579\/revisions"}],"predecessor-version":[{"id":9616,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/9579\/revisions\/9616"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/9587"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=9579"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=9579"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=9579"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

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

STORAGE<\/h2>\nCalcitonin (Salmon) Injection should be protected from light and stored at a temperature of 2\u00b0 to 8\u00b0.<\/p>\n

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

STORAGE<\/h2>\n
Calcitonin (Salmon) Injection should be protected from light and stored at a temperature of 2\u00b0 to 8\u00b0.<\/p>\n