The Need of Methods of Analysis of Pharmacopoeical Articles

May 1, 2002 - The Need of Methods of Analysis of Pharmacopoeical Articles. B. L. Murray · Cite This:J. Ind. Eng. Chem.1909111775-776. Publication Date...
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ADDRESSES sugar present and consequently the ability of the syrup to resist crystallization with a low water content. This fact was recognized by the Standards Committee when it made 30 per cent. the maximum water limit for cane syrup a n d molasses with 2 . 5 per cent. ash, as against 35 per cent. of water for a sugar syrup with no ash or solids-not-sugar. One-half per cent. ash represents approximately the solids-not-sugar t h a t will permit the lowering of the water limit by I per cent. If the same reasoning were applied to maple syrups with a n ash content of about per cent., which all concede to be correct, the water limit would be placed at 34 per cent. This theory is borne o u t by practice. The maple syrups now on the market have a n average water content of from 31% to 32% per cent., a fear of resulting crystallization keeping the manufacturers from going below this limit. This is too close to the legal limit to be comfortable. A slight variation in testing the degree in boiling down might make a n otherwise pure syrup illegal. If the standard were raised to 34 per cent. a limit would be established t h a t would be practical not because i t enables the manufacturer to add z per cent. of water to his product b u t because it places a limit t h a t would not have to be approached so dangerously near in order t h a t a merchantable product may be obtained. T h e manufacturer would keep his syrup between 32 and 33 per cent. of water because fermentation a n d crystallization make very good watch-dogs to keep him from varying either way to a n y extent. If the standard for the water content of syrup were 34, the ash of sugar on a water-free basis would have to be made 0.68 per cent. to correspond. The ash of the sugar may be higher than this, b u t a t least 0.68 per cent. on a water-free basis must go into solution in water in order that a legal syrup m a y be made from it. As standards, therefore, the following are suggested : Maple sugar is the solid product resulting from the evaporation of maple sap or maple syrup and contains not less than 0.68 per cent. of maple sugar ash in the water-free substance, and on solution in water will yield a clarified maple syrup, containing not less than 0.45 per cent. maple syrup ash. Maple syrup is the product resulting froni the evaporation of maple sap or the solution of maple concrete or sugar and contains not less than 0.45

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per cent. niaple syrup ash and n o t more than 34 per cent. water.

ADDRESSES. THE NEED OF METHODS OF ANALYSIS OF PHARMACOPOEIAL ARTICLES.' B y B. L. MURRAY.

The United States Pharmacopoeia is well and intimately known to all the pharmaceutical chemists here to-dxy. I t is probably known in a general way to all the chemists of our association. But, notwithstanding this, the book is such a n important one that it is worthy our close attention, for a short time a t least. I t is, without doubt, the most important law book that is written by laymen. While it is revised and put forth by a mere handful of men i t is in effect the law for all our millions of population. I t may safely be said that directly or indirectly i t exerts its influence on each and every inhabitant of the United States and its possessions, for they all take medicine. Such a text is to be respected. The pharmacopoeia lays down standards of purity and of strength for drugs and medicinal chemicals, and by virtue of the Food and Drugs Act these standards become in effect a p a r t of the law. The book tells us what properties characterize preparations for medicinal use, how to make some of the preparations, how to test them, how much of them to take a t a dose, etc. No better pharmacopoeia is published and for the greater part of i t only praise can be offered. But like everything else artificial in its origin, i t has defects, and, as is customary, the virtues will be dismissed with a mere mention, while the defects, or one of them, will be dwelt upon. I have just said that the pharmacopoeia prescribes for' us the quality and strength of our medicines, and how to test them. This statement must be modified. The pharmacopoeia tells us the required strength of practically all the articles within its purview, and tells us how to test some of them. The tests given, or, rather, those not given at. all are the crux of this paper. 1Vhenever in the text freedom from chlorides, or sulphates, or phosphates, or iron, or most any of the simples is required, the appropriate qualitative test is given. But when i t is required to employ a more important test, such as a quantitative assay method, the pharmacopoeia frequently gives no such test a t all. Kow this really is unfortunate, to put i t mildly, for the purity requirements of the book are in the main high, and are all binding on those handling the preparations. If degrees of purity difficult to attain and maintain are required, of course in simple justice methods of ascertaining those degrees of purity should be stated. The selection of methods of analysis a t random by different chemists is a poor practice. The metallic mercury of the C . S. P. is an example of the condition mentioned. Metallic mercury to meet the requirements of purity must contain 99.9 per cent. of mercury. Only one-tenth of I per cent. of impurities allowed-and official assay method given by which to test. This : a n extreme case, but merely typifies many other, zinc, practically never taken internally, miis Read before the Section of Pharmaceut:' American Chemical Society, a t Detroit.

7 16 per cent. of zinc. No tnethtxl of testing is given; tlirit is, cluiintitative iiietliid of dctcrniining tlie per cent. of xitic is given. There arc mony such instances. U’s kiiow I\ Iiy tlie present pIicirin;ico1)oeiu fails i n twiny CYISCS to give tlicsc most important rnethcds. A t the t h e the I)o& \viis published it \vns not :I nutionti1 lcgul st:indard, Irut I~ec*atiie so subsequently, with the pussnge of the Pood t i n t 1 Drugs Act. Tlic need o f riictliotls was fornirrly not so grwt, titid \ \ l i e i ~ii rdiitiivly siniple test SUCII ns a volumetric or ; i n eiisy gr:ivinietric nietlicid could not be found, none nt ti11 \ + . I S put into the text. The ideii w i s , also to employ tests rcclriiriirp tlic riiiniriiuni iif apparatus and generiil equipmcnt, on tlir iissuiiiption, it is said, tlint retnil druggists :ire the principl iiscrs of the tests. So niurh for tlie prcuvtt Iili:iriiincnl~oeiii-tlic I:. S. 1’. 8th rCvi4in. ’The hook hiis ci1re:idy been printed nntl clistril~tited, has I I ~ C W r e v i d cind corrected by supplt.nantnry circuI:irs, and has nearly served out its time. But w l i i i t of tlic next revision, tlie ninth, the convention for which iiiccts in JIiiy next i How shall tlie clucstion of purity reqtiircnicnts in ttwis ( I f per cent., nnd niethods of assaying be Iiantllcd? .\re we again to till tlie pages with tests for chlorides, etc., m t l omit the rcnlly iniportnnt and mitre difficult nirtliods o f asaiy? Are w e again to confine oursclves to easy volumetric or gravimetric determinations when there are better and inore suit:il)le. though less easy ones, a t liand? Are we phariiiacctitical cheinists willing to be tleiiierl tlie privilege of riiaking use of the latest cidvanc*esin analyticd chemistry? bliist we forego tlie pleasure of usinK the riiodern oxidizers such as stnliiim peroxide and the persii~plvates? Do we not know the remarkable acivmccs that hiive been innrie in electro-analysis? C m we close our eyes for another ten years and bring out a ne\v pliarnincopoein, ignnring a11 these advantages a t our servicr, and all for the sake of keeping things siniple? It dtwrs not seem possible to me. I n our next ph:irniaco~mia we need modern niethtwfs of analysis. Or a t least we sliould accord ourselves the privilegc of using such nletlids. To hcorporiite full quantitative niethcxis o f determining gold, mercury, zinc, antimony, and all the others, would enlarge the honk very materially, arid this is possibly objectionable. For the phartii:icop(xiu to refer the chemist to sonic standard text-book for methods of nniilysis would hardly be justifiable or desirable. I suggest therefore that the Committee of Revision of the Pherniaco~weiafollow the example of the Department of Agriculture in lt’ashington. As-all know this departnient accepts or adopts the methods o f ?analysis of the Association of Official Agricultural Chemists. I k t the Coniniittee of Revision adopt a s their methods of analysis the rncthrds of the American Chemical Society. And it will k an excellent beginning for this the new Division of Pharniaceutical Chemistry to investigate, and if possible agree upon some or a few of the methods of analysis now entirely omitted from and so much needed in the United States Pharmacopnein. Possibly the methods thus worked out and approved by the American Cheniical Society could be made sufficiently attractive to tempt the Cnmmittee of Revision to use or refer to them. I therefore offer the suggestinn that this Division of Pharmaceutical Chemistry take u p the investigation of methods of analysis of pharmacopoeial articles with the idea ofwlccting what maybe termed shndard mctthods of nnnlysia

BOOK REVIEWS AND NOTICES, .

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Ijy I)R. W.GI%RTLI~R.Volunr I. 6%~stitittion. Part r , Ikrlin: Crhrirder Dorntraegcr. PAX, 4 Mk, 2 0 I’f. l’liis is the first part of what protniw~ito Ir rc couiprehensivc traitisc on tlie subject of wetdlogrq)hy, NUBSs:irily future piirts m i s t decide : i to ~ the rrrerilf of tlie worlr :IS ii wliolc, h i t tfic first part gives grtvt promire, Tbt chaptcrs ;ire: I, Introduction: JI, Constitution in Relalion to Temperntiire; 111, Solid Sdutiom iind Cotripundr; IV, Condition Ikigriiiiis; First Group. h l w r , typography, illust r,itions ;rnd gcncriil apl)iur;incc ilrc tlie k s r .

Metalloprrphy.

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OFFICIAL REGULATIONS A N D RULINGS.

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(’1‘-

D. 1524,)

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tiaturctl :ilcoliril prolii1)itcvl and forriiic ctlier.

, 4 / c d ~ L--Us!of specially detlic 111:111~1:ictiire of butyric

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’1‘RlfAhl’HY I)IJPART#BNT, ()i:ricis 01:C c ) ~ i ~ ! I s ~ I o xov l % INTERNAL Hsvrr~t~e,

\ ~ A S l l I N l i T o X , n. c., Aiipust 5 , IIFW). G i w r L w m : Your let tcr of tlic .?Ist ultimo, :Iddrehsed to thc chief clicniis(, :ind iii:ikiiifi applicii tion for the authorization of formu1:i So. I for use in the tii;inufacture of butyric and forniic ctlier, lins lieen received, and tlie matter given careful considcration by this ofice. ’I‘lie f:ict is recognized that tlie substances in question fulfil tlic conditions imposed I)y the ainendatory act in being “definite clwniicd siibst:ttices” Iiroduced from ;tlcohol by niolccu1:ir tlccririiposition, and tlicir manufacture from denatured alcoliol could 1:iwfully be permitted under .%tion 40, Part \‘I of 12cgulaticins So. so. I n view of tlic fact, htwcver, tlitit these ethrrs are ustvi riininly as flavoring niiiterinl in beverages, and tlie f u r t k r fiict, wliich is apparent froni your coriiintiiii~;~tion,that they must necessarily carry a considerable Inwxnc;tge of undecomposcd alcohol, 1 do not consider it t o le for tlw best interests of the Covernnicnt, or in accord with tlw spirit and intent of the dcn;itured :~lcohollaw, to perinit tax-free alcoliol to be used in their ~ i ~ ~ t n ~ f i l cIt ~niust. rc. therefore, deny your application. Respectfully, HOIST.WILLIAMS, JR., tl d i n g C’ommiA s ibntr Messrs. -,

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Judgment Nos. 92-99, Food and Drugs Acts. 9-1. Misbranding of canned peaches, plums, pears and apricots (underweight). 93. Misbranding of canned beans (underweight), 94. Misbr5nding of water (artificially lithiatcd water Inbeled as :i natural product). 9s. bfisbrmding of canned corn (underweight? 96. Misbranding of n cereal (as to quality and d i p t i w properties). 97. Misbranding of canned tomatoes (underweight). 98. Adulteration und misbranding of syrup (as to prcarm of maple sugar). 99. Misbritnding of syrup (as to place of manufacture a& ahoust of tnaple sugar present).