Report of the Council on Pharmacy and Chemistry
H. K. Mulford Company and E. R. Squibb and Sons submitted to the Council ampules containing solutions of iron citrate green. It thus became necessary to consider the eligibility of iron citrate green itself for admission to New and Nonofficial Remedies. As the rules of the Council provide that nonessential modifications of official or nonproprietary preparations will not be recognized, the above named firms were asked to state what advantages, if any, the so-called iron citrate green had over the official iron and ammonium citrate. In reply the H. K. Mulford Company wrote that it had come to the conclusion that iron citrate green and ampules thereof would undoubtedly be considered by the Council as a nonessential modification of an official product, adding:
“It seems to differ from the official ferric citrate so far as essentials go only in color, but custom, which is exceedingly hard to change in South America, demands that this green variety of ampules be used in place of the official product.”
In reply to a similar letter of inquiry E. R. Squibb and Sons wrote:
“Iron citrate green (iron and ammonium citrate green) differs from the U. S. P. iron and ammonium citrate in that it contains less iron and more citric acid and more ammonium citrate than does the latter. It is of course a modification of the official salt and is supplied to meet a real demand. Its reaction is quite decidedly acid and our present stock contains Fe slightly below the U. S. P. requirements for iron, assaying 15.74 per cent. instead of 16 per cent. Fe. The tests used to control its quality are those for the official product except as before indicated, it is always acid instead of neutral, as the U. S. P. requires for that salt.”
The smaller iron content (98 per cent. of the U. S. P. requirement) of the green variety referred to by E. R. Squibb and Sons is so small as to be negligible. Further, the low iron content as well as the acidity of the green salt would appear to be detriments rather than advantages. Inasmuch as no evidence has been presented to show that iron citrate green is superior in any way to the well-known iron and ammonium citrate the Council held that iron citrate green, and with it the dosage forms, was ineligible to N. N. R.
The preceding report was submitted to the Mulford Company and to E. R. Squibb and Sons for comment before publication. The former firm replied that in the present case it felt bound to supply the existing demand, the latter replied that, to give the Council its support in this matter, the sale of iron citrate green and ampules thereof would be discontinued.—(From The Journal A. M. A., Jan. 13, 1917.)