29238 Acetanilid Tablets (Direct Sales) 343.0 366.0 356.9 23.0 6.4 382.0 404.0 391.0 22.0 5.6 29975 Acetanilid Tablets (Tilden Co.). 30208 Acetphenetidin (Direct Sales Co.)... 338.0 364.0 353.0 29950 Aspirin (Harvey Co.). 378.0 389.6 382.5 11.6 3.0 29940 Aspirin (Lee & Osgood). 29210 Aspirin (Tailby-Nason). 29215 Aspirin (Yates D. & C. Co.)... 29901 Aspirin (Yates D. & C. Co.).. 29912 Aspirin (Yates D. & C. Co.).. 940 Blaud's Iron Pills (United Drug Co.).... 30206 Calcium, Iodized (Direct Sales) Co.).. 29229 Calcium Sulphide Pills (Upjohn Co.).... 29230 Calcidin (Abbott Laby.).. TABLE XV. VARIATIONS IN WEIGHT OF TABLETS-Continued. 29908 Hydrastin Strychnine Trit. (Smith Pharmacal Co.).. Co.).. 414.0 469.5 435.5 15.5 18.0 16.6 2.5 15.1 34.9 40.0 37.5 5.1 13.6 29228 Migraine Tablets (Nat. Drug 29225 Migraine Tablets (Tailby-Nason) 220.0 236.5 226.0 29247 Nitroglycerine Tablets (Nat. 29213 Phenolphthalein Tablets (Direct 29246 Quinine Sulphate (Nat. Drug 30203 Quinine Sulphate (Yates D. & C. Co.) 29910 Sedative Pills No. 3 (G. F. Harvey Co.).. 29953 Sodium Bromide (A. D. S.). 29978 Sodium Bromide (TailbyNason)..... 29236 Triple Bromides (Tailby-Nason) 29961 Sodium Salicylate (Daggett & Miller). 148.0 168.5 162.9 20.5 12.6 40.5 16.0 245.5 261.0 253.2 15.5 6.1 288.0 307.0 299.0 19.0 6.4 319.0 368.0 350.0 49.0 14.0 390.8 499.3 432.0 108.5 25.1 370.0 412.0 392.5 42.0 10.7 640.0 658.0 650.0 18.0 2.8 495.5 516.5 506.2 21.0 4.1 TABLE XV. VARIATIONS IN WEIGHT OF TABLETS-Concluded. 29208 Sodium Salicylate (Rheumatic Tablets) (Maltbie Chem. Co.) 798.0 831.5 813.6| 33.5 4.1 29931 Sodium Salicylate (Haberle 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: *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: 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. |