XEROFORM-HEYDEN AND BISMUTH TRIBROMPHENATE-MERCK OMITTED FROM N. N. R.
Report of the Council on Pharmacy and Chemistry
The Council has authorized publication of the following report on Bismuth Tribromphenate-Merck and Xeroform-Heyden. These two products were found not to comply with the standards for bismuth tribromphenate adopted for New and Nonofficial Remedies, and hence could not be retained. As the manufacturers of both products announce that efforts toward the production of a satisfactory product are continued, the omission of the two brands is without prejudice to their reacceptance when a satisfactory product becomes available.
W. A. Puckner, Secretary.
The referee in charge of bismuth preparations submitted the following report of the A. M. A. Chemical Laboratory which shows that Xeroform-Heyden and Bismuth Tribromphenate-Merck do not comply with the adopted standards for bismuth tribromphenate.
Some time ago a request was received from the Medical Section of the National Council of Defense for a report on a brand of bismuth tribromphenate. In accordance with this request the firm’s product was examined, and at the same time and for comparison, an examination was also made of a specimen of bismuth tribromphenate received from Merck and Company, October, 1915, and of another specimen of bismuth tribromphenate “Xeroform-Heyden” obtained from the Chicago branch of the Heyden Chemical Works in April, 1918.
The examination brought out that the bismuth tribromphenate submitted to the national Council of Defense contained a large amount of uncombined tribromphenol, while the specimen of Xeroform-Heyden contained an excessive quantity of bismuth.
When the latter finding was submitted to the Heyden Chemical Works, the firm stated: “The product had to be made in this country after importations from Europe became impossible and the first lots were not fully up to the standard ...” The firm stated that it could now furnish a product which it considered fully equal to that which was previously imported, and offered to submit “samples of the new material.”
Having been requested to do so, a specimen of Xeroform-Heyden was received from the Heyden Chemical Works, New York. This and a second specimen, purchased from a Chicago wholesale drug house, were examined. Whereas the standards for bismuth tribromphenate which had been formulated by the Laboratory and accepted by the Heyden Chemical Works required that the product should contain from 40 to 49 per cent. of bismuth and contain not more than 3.3 per cent. of uncombined tribromphenol, the specimen purchased in Chicago contained 67.7 per cent. of bismuth, while the specimen received direct from the Heyden Chemical Works contained 24 per cent. of uncombined tribromphenol. When this result was reported to the Heyden Chemical Works, the firm replied:
“It seems that we are not yet in a position to supply a product that answers a uniform standard and that we have to continue our efforts in this direction.
“We will take this matter up with you again as soon as we have been successful ...”
At the time when the preceding examination was being made, bismuth tribromphenate-Merck could not be obtained from the Chicago wholesale houses. A request sent to Merck and Company for a specimen of the market supply brought the information that the product was temporarily unavailable. Though unable to supply the product, the firm gave valuable advice for a revision of the somewhat loosely drawn tests for bismuth tribromphenate in New and Nonofficial Remedies, 1918.
Recently (November, 1918) Merck and Company sent a specimen of its product labeled “Bismuth Tribromphenate-Merck” “Merck and Company, New York, Distributors and Guarantors,” and wrote “... You will notice this sample conforms in nearly all details to the tests we submitted with our letter of June 4th. We have been able to produce better goods, but just at present unsatisfactory starting material confronts us. The sample conforms to N. N. R., 1918, but will not meet the test for uncombined tribromphenol submitted by you in your letter of September 4th ...”
Examination of the specimen demonstrated that it was soluble to a considerable extent in alcohol (the N. N. R., 1918, description provides that it should be only slightly soluble in alcohol) and according to the standards adopted for New and Nonofficial Remedies, 1919, contains 18 per cent. uncombined tribromphenol (more than five times the permitted amount).
In view of the Laboratory’s report, the referee recommended that the acceptance of Xeroform-Heyden and Bismuth Tribromphenate-Merck be withdrawn, without prejudice to their reinstatement when satisfactory products are again offered for sale. The Council adopted the recommendation of the referee, and accordingly Xeroform-Heyden and Bismuth Tribromphenate-Merck are omitted from New and Nonofficial Remedies, 1919.
When the Laboratory’s findings with regard to Xeroform-Heyden and the action of the Council deleting the article from New and Nonofficial Remedies was reported to the Heyden Chemical Works, the firm expressed regret that efforts to produce a product equal to that formerly obtained from Germany had so far not been successful and announced that it had decided to withdraw Xeroform-Heyden from the market for the present.
When Merck and Company was advised in regard to the report of the Laboratory and the Council’s action, this firm questioned the feasibility of producing a product meeting the Council’s standards and suggested that the test for free tribromphenol be revised to permit as much as 15 per cent. of this constituent. When Merck and Company was reminded that its product, submitted in 1915, essentially complied with the adopted standards and that the estimate of the therapeutic value of bismuth tribromphenate is based on a product essentially free from alcohol-soluble material, the firm replied:
“As stated in our letter of the 12th inst. we do not wish to market the chemical unless it meets all legitimate requirements of the physicians that use it. If, therefore, your standard proves to be good and it is commercially possible to make supplies conforming to it, we shall do so. We shall discontinue the article unless it is of suitable quality.”
—(From Reports of Council on Pharmacy and Chemistry, 1918, p. 76.)