SPL Set ID: 22f2986f-309c-4133-9e92-1c040453f340

Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish. Calcitonin salmon injection USP, synthetic is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula: Calcitonin salmon, USP is a white to off-white powder. It is soluble in water and 1% aqueous acetic acid. Its chemical name is L-cysteinyl-L-seryl-L-asparginyl-L-leucyl-L-seryl-L-threonyl-L-cysteinyl-L-valyl-L-leucyl-glycyl-L-lysyl-L-leucyl-L-seryl-L-glutaminyl-L-alpha-glutamyl-L-leucyl-L-histidyl-L-lysyl-L-leucyl-L-glutaminyl-Lthreonyl-L-tyrosyl-L-prolyl-L-arginyl-L-threonyl-L-asparginyl-L-threonyl-glycyl-L-seryl-glycyl-Lthreonyl-L-prolinamide (1->7)-disulfide and chemical structure is: Its molecular formula is C 145 H 240 N 44 O 48 S 2 and its molecular weight is 3432 Daltons. Calcitonin salmon injection, USP, synthetic, 400 USP Units/2 mL (200 USP Units/mL) is available as a sterile, clear, colorless solution filled in individual 2 mL multiple-dose clear glass vials for subcutaneous or intramuscular injection. Each 1 mL contains: Active: Calcitonin salmon, USP …………………………...…….0.03333 mg (equivalent to 200 USP calcitonin salmon units) Inactives: Acetic acid, USP ............................................................... 2.25 mg Phenol, USP ...................................................................... 5.00 mg Sodium acetate trihydrate, USP………………….……...... 2.00 mg Sodium chloride, USP ....................................................... 7.50 mg Water for injection, USP, q.s. to ........................................ 1.00 mL The activity of calcitonin salmon injection, USP is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin salmon for Bioassay, distributed by the National Institute for Biological Standards and Control, Holly Hill, London. graphic 1