Alkaloids European Pharmacopoeia 231

The test identifies the substance to be examined as an alkaloid. Alkaloids are a very large class of substances with a somewhat vague definition. Traditionally alkaloids have been identified with the use of four analytical reagents Mayer's reagent, a potassiomercuric iodide solution Wagner's reagent, a solution of iodine in potassium iodide Hager's reagent, a picric acid solution Dragendorff's reagent, a potassium bismuth iodide solution One definition of an alkaloid is that it is a substance...

Ch3 ch c

Technically it can be prepared by fermentation of various carbohydrates, among others glucose. It has one carboxylic acid group with a pKa value of 3.8. It is soluble in water, alcohol, and furfurol but less soluble in ether. It is practically insoluble in chloroform, petroleum spirits, and carbon disulphide. The acid form is a crystalline powder that has a boiling point of 16.8 C, and the salts are likewise usually crystalline substances. A color reaction...

Total ash European Pharmacopoeia 2416

The test ensures that the substance to be examined has a content of inorganic ash, which is below the limit defined in the individual monograph. Total ash is one of the three ash values, which traditionally have been used in the evaluation of vegetable drugs total ash, acid insoluble ash, and sulfated ash. The total ash is the residue obtained when the vegetable drug is carefully ignited to burn off all the carbon. The residue consists of inorganic salts either naturally present in the...

Alkaline impurities in fatty oils European Pharmacopoeia 2419

This test ensures that the fatty oil to be examined has a content of alkaline impurities, which is below the limit defined in the individual monograph. The need for controlling alkaline residues in fatty oils comes from one of the procedures used to purify crude vegetable oil into pharmaceutical grade oil. The fatty oils covered by the purpose of the test are triglycerides of miscellaneous fatty acids. Triglycerides, called fixed fats or fixed oils, are used for the storage of energy in both...

Arsenic European Pharmacopoeia 231

The test identifies the substance to be examined as a salt of arsenic(III) or arsenic(V), or a compound containing bound arsenic made available for analysis by chemical degradation. Due to their potential toxicity, arsenic substances must be considered mostly a reminiscence of historical interest. Before World War II a fairly large group of substances containing covalently bound arsenic was used in the treatment of protozoa. One of the most widely known arsenic drugs was arsphenamine (Figure...

Heavy metals European Pharmacopoeia 248

The test ensures that the substance to be examined has a content of heavy metals, which is below the limit defined in the individual monograph. Heavy metals are in the test defined by the selectivity of the methods to include lead, copper, silver, mercury, cadmium, bismuth, ruthenium, gold, platinum, palladium, vanadium, arsenic, antimony, tin, and molybdenum. The contents of heavy metals in active pharmaceutical ingredients and excipients are tested for two reasons due to the toxicity of the...

Color reactions in limit tests

Visually comparing the color intensity of a sample with a standard of known concentration, after reacting both with a selective reagent, is a very old analytical principle. In the second half of the nineteenth century, it was discovered that several (colorless) alkaloids and other pharmaceutical substances produced characteristic colors when treated with certain inorganic reagents. These reactions made possible semiquantitative determinations of the substances, but there was most often no...

Ammonia Release Pharmacopea Method

This method first described by Nash in 1952 has the advantage over many of the other colorimetric formaldehyde methods in that the reaction takes place under relatively mild reaction conditions. One disadvantage, however, is that a reaction is gained not only with free formaldehyde but to some extent also with bound and, although to a limited extent, polymeric formaldehyde. Figure 6.15.1 3,5-diacetyl-1,4-dihydrolutidine. For vaccines for human use, a 1 in 10 dilution of the vaccine to be...

Xanthines European Pharmacopoeia 231

The test identifies the substance to be examined as a member of the group of compounds called the xanthines, and at the present about 10 monograph reference xanthines. Xanthines are compounds that historically have been extracted from plant material containing the core element of xanthine (Figure 3.34.1). Biochemically they are derived from the nucleotide purine (Figure 3.34.2). The different xanthines have various alkyl groups attached to the three nitrogen atoms not participating in the...

Silver European Pharmacopoeia 231

The test identifies the substance to be examined as a salt of silver (Ag+). At the present silver is referenced in only one monograph, silver nitrate. This salt is sold in sticks, called Lapis or Lapis lunaris, and is used for the treatment of warts. Silver can exist both as silver(I) and silver(II), but since the latter is less stable, silver(I) dominates. It is a noble metal meaning that it is most stable in oxidation state 0, its metallic form. So, contrary to most metals, it does not have...

Method b

Test solution (a) in 200 dilution of the vaccine to be examined with R is prepared as described in the pharmacopoea. Solutions containing 0.25 g l, 0.50 g l, 1.00 g l, and 2.00 g l of CH2O by dilution of formaldehyde solution R with R are prepared. To 0.5 ml of the test solution and of each of the reference solutions in test tubes, 5.0 ml of a freshly prepared 0.5 g l solution of methylbenzoethiazolone hydrazone hydrochloride R is added. Tubes are closed, shaken, and allowed to stand for 60...

Free formaldehyde European Pharmacopoeia 2418

The test ensures that the substance to be examined has a total content of formaldehyde (H2CO), which is below the limit defined in the individual monograph. The monograph is named free formaldehyde to exclude its use on formaldehyde groups chemically bound to the substance to be examined. The test is referenced in about 30 monographs all describing vaccines, all of them referencing method (a) and nearly all of them having a free formaldehyde limit of 0.2 g l. Vaccines are inactivated virus...

Mercury European Pharmacopoeia 231

The test identifies the substance to be examined as either a salt of mercury, Hg22 or Hg2 or a substance containing covalently bound mercury. At the present, reference to mercury is made in only two monographs. One is an inorganic salt mercuric chloride, HgCl2, which has antibacterial action through precipitation proteins and thimerosal Figure 3.24.1 , which likewise is an antiseptic but also a preservative in pharmaceutical product. The use of mercury compound has been diminished due to its...

Precipitate appearance

Precipitates have often been placed in one of three different categories based on their macroscopic appearance. A precipitate can be colloidal, crystalline, or curdy gelatinous. The kind of precipitate given by a specific salt has no correlation to its degree of insolubility but is determined by the particle size distribution of the precipitate, and its affinity toward the water molecules and ions of the surrounding solution. Identification tests are most often designed to give fast results. In...

Calcium European Pharmacopoeia 231

The test identifies the substance examined as a salt of calcium, Ca2 . Reference to calcium is made in about 30 monographs. Owing to the tendency of calcium to form insoluble salts, it is not a common salt of choice for active pharmaceutical ingredients, so the majority of the monographs are for inactive excipients. Among the exceptions are the calcium salts of several amino acids. Being an alkaline earth metal, calcium is found only in the valance two form. Its hydroxide salt is relatively...