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VARIATIONS IN MEDICAMENT.

In addition to variations in medicament caused by the limitations of weight control, other factors enter into consideration, such as the purity of the basic drugs used, the mixing of them, and finally the limits of reasonable error in analysis. The manufacturer must be presumed to have determined that the drugs he uses conform to the limits of purity prescribed by the U. S. Pharmacopoeia or National Formulary, or, in case of drugs not recognized therein, to a degree of purity established by reliable analyses, and to have based the claims for his finished product accordingly. Approved analytical methods1 are available for many of the medicaments ordinarily encountered in products of this type; but conclusions must be drawn cautiously in case of methods, the limitations of which are not sufficiently established.

Table XVI gives maximum and average variations in medicament in terms of grains per tablet and in percentages referred, in both cases, to the quantities of drugs declared to be present. A study of the tabulation shows that the maximum variation from the dosage claimed has been a shortage in sixty-one items and an overage in forty items; in other words the -and +variations have been about 6:4. In more than one-half of the items determined, the variation in dosage between the lightest and heaviest tablets or pills was within 10 per cent. of the dosage declared; in over threefourths of the items this range was less than 15 per cent.; and in nearly seven-eighths of the items the range did not exceed 20 per cent.

If the average variation from claimed dosage is considered, the comparison is, naturally, somewhat better. Thus we find that the average variation from the stated dose is less than 10 per cent. in about four-fifths (79.8 per cent.), of the items determined; in about two-thirds (65.4 per cent.) of the items the variation does not exceed 5 per cent.

These conclusions are best shown in tabular form as follows:

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*Includes one item (in 29960) which is obviously a mistake in labelling.

Again we may refer to a similar summary revised to a basis

1 Methods of the A. O. A. C. and of the U. S. Pharmacopoeia have been followed wherever possible.

2 Conn. Exp. Sta. Bull. 200 (1917).

comparable with the above tabulation. The comparison as regards maximum variation from claim is as follows:

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Since an improvement has been shown in the matter of uniformity of weight of tablets as compared with our previous inspection, less variation in medicament would, therefore, be anticipated at this time. The above comparison shows that such is the case. About 55 per cent. of the determinations made were within 10 per cent. of the quantity of drug declared as compared with 45 per cent. showing a like range in 1917. Twenty-two per cent. of the individual items determined varied from the stated dose by 15 per cent. or more while the corresponding figures in our previous inspection is twenty-eight per cent. The improvement in uniformity of medicament parallels rather closely the increase in uniformity of tablet weights.

TABLE XVI. VARIATIONS IN MEDICAMENT IN TABLETS, ETC.

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TABLE XVI. VARIATIONS IN Medicament in Tablets, eTC.—Continued

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TABLE XVI. VARIATIONS IN MEDICAMENT IN TABLETS, ETC.-Concluded

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Table XVII gives the analytical data obtained upon the tablets and pills examined, ninety-two in number. In general, the plan adopted for judging the products was to designate as "satisfactory" the tablets or pills in which the average quantity of medicament equaled the quantity claimed, and in which the variation in medicament, as calculated for the lightest and heaviest units, did not exceed 10 per cent. of the claimed dose. Tablets or pills in which the average quantity of medicament was found to be within 10 per cent. of the quantity claimed were "passed." In a few instances where the quantity of medicament was very small, or where it could not be determined with the exactness desired, the latter designation was used with somewhat more tolerance. This plan is not ideal, but it is based upon the belief that some distinction should be made between those products which show a conspicuous degree of uniformity and those which do not, and, furthermore, that the average dose should equal the declared dose, and that variations should be+ and —in about equal magnitude. It is recognized that a tolerance which may be perfectly fair as applied to aspirin tablets, for example, may be very irrational when applied to hypodermic tablets. This is a subject

which needs further consideration. The kind and amount of drug involved and the effects likely to result from an overdose must be taken into account in determining the magnitude of reasonable tolerances.

Particular comment is due with respect to a number of analyses listed in Table XVII. 29960. Acetasal. This product shows about twice the quantity of caffeine citrate indicated by the label; in other words, our results show about 2.5 per cent. caffeine instead of 2.5 per cent. caffeine citrate. This is evidently an error in labelling. In our previous inspection a product of similar name and made by the same manufacturer was declared to contain 2.5 per cent. caffeine.

29228. Migraine Tablets No. 8. The deficiency in sodium salicylate exceeded 10 per cent. but other ingredients were substantially correct and the tablets were passed.

29209. Acetanilid Sodium Compound. This was correct in the main ingredients and the deficiency in sodium bicarbonate was passed.

29248 and 29248 D. Sodium Salicylate. These samples were low in sodium salicylate but both were from the same stock. No other sample of this manufacturer was found among the physicians visited.

29216 and 29216 D. Strychnine sulphate. Both these samples contained excesses of medicament but both were from the same source. No other samples of strychnine sulphate of this make were found among the physicians visited.

To summarize, it may be said that of 92 samples, representing thirty-three manufacturers (2 samples were of unknown make), 29 were satisfactory and 57 were passed. Six varied from claim by considerable amounts. These were Acetasal, 29960 (with the comment noted), sodium salicylate, 30214, strychnine sulphate, 29216 and 29216 D, and sodium salicylate, 29248 and 29248 D.

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