» Cyanocobalamin Injection is a sterile solution of Cyanocobalamin in Water for Injection, or in Water for Injection rendered isotonic by the addition of Sodium Chloride. It contains not less than 95.0 percent and not more than 115.0 percent of the labeled amount of anhydrous cyanocobalamin (C63H88CoN14O14P).
Packaging and storage Preserve in light-resistant, single-dose or multiple-dose containers, preferably of Type I glass, and store at controlled room temperature.
Identification The absorption spectrum, in the range of 300 nm to 550 nm, of the solution employed for measurement of absorbance in the Assay exhibits maxima at the same wavelengths as that of a similar solution of USP Cyanocobalamin RS, concomitantly measured, and the ratio A361/A550 is between 3.15 and 3.40.
Bacterial endotoxins 85 It contains not more than 0.4 USP Endotoxin Unit per µg of cyanocobalamin.
pH 791: between 4.5 and 7.0.
Other requirements It meets the requirements under Injections 1.
Assay Dilute, if necessary, an accurately measured volume of Injection, equivalent to not less than 300 µg of cyanocobalamin, quantitatively and stepwise with water to a concentration of about 30 µg per mL. Dissolve an accurately weighed quantity of USP Cyanocobalamin RS in water, and dilute quantitatively and stepwise with water to obtain a Standard solution having a known concentration of about 30 µg per mL. Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 361 nm, with a suitable spectrophotometer, using water as the blank. Calculate the quantity, in µg, of C63H88CoN14O14P in each mL of the Injection taken by the formula:
10(C/V)(AU / AS)in which C is the concentration, in µg per mL, of USP Cyanocobalamin RS in the Standard solution; V is the volume, in mL, of Injection taken; and AU and AS are the absorbances of the solution from the Injection and the Standard solution, respectively.
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USP32NF27 Page 2036Pharmacopeial Forum: Volume No. 29(6) Page 1865