Description, specification, pharmacopoeias

All povidone grades are of pharmaceutical purity. They are free-flowing white or yellowish-white powders with different particle sizes (see Section 2.2.4). 

The typical odour of the individual products depends on their method of synthesis and is therefore not the same for all the grades of povidone. Povidone K 25 and Povidone K 30, for instance, always have a typical amine or ammonia odour, as ammonia is used for neutralisation. 

All the povidone types give aqueous solutions with very little taste. 

The products are tested according to the corresponding monographs for Povidone in the supplements of Ph.Eur. 5 and in USP 26. Their release for sale depends on fulfilment of the requirements of these monographs. 

The low-molecular grades povidone K 12 and povidone K 17 are tested for absence of bacterial endotoxins according to Ph.Eur. Method 2.6.14. A 6% solution in 0.9% sodium chloride solution is used. The validation of the endotoxin test (Ph.Eur. method 2.6.14) was done with povidone K 17 [609]. 

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The most influential of these test protocols are the USP, - the European Pharmacopoeia (EP), the Pharmacopoeia of Japan (JP), - the Organization for International Standardization (ISO), and the Parenteral Drug Association (PDA). ° USP<381>, Elastomeric Closures for Injections, contains five chemical tests and two biological tests. Closures must meet the biological requirements but there are no current specifications for the chemical tests. All USP chemical tests are commonly performed on aqueous extracts but isopropyl alcohol and the drug product vehicle are also permitted. A brief description of the USP<381> tests follows. ... 

Description, identification, specifications, and tests of L-ascorbic acid and sodium L-ascorbate are given in the U.S. Pharmacopoeia 15) and the Food Chemicals Codex 16). Similar information on palmitoyl L-ascorbic acid (ascorbyl palmitate) is contained in the Codex. Sodium ascorbate is twice as soluble in water as ascorbic acid. Ascorbyl palmitate is soluble in ethanol (25°C) at 12.5%, in hot (80°C) glycerin, propylene glycol, or decaglycerol octaoleate to 10%, in vegetable oils (25°C) at 0.01--0.1% and in water (70°C) at 0.2%. 

Specifications for excipients Pharmacopoeia copy of the monograph, test methods referenced Additional specifications Non-pharmacopoeia list of tests and for each excipient, including solvents, liquids to adjust pH, coatings, capsule shell, and inked imprint (on the dosage form), description of test methods, microbiological limits, colours EU/FDA/Japan ... 

In essence, the pharmacopoeias are compendia of end-product specifications for therapeutic substances and descriptions of methods approved for testing substances against these specifications. Methods for detecting nonsierility were introduced into the British Pharmacopoeia in 1932 and into the United States Pharmacopoeia in 1936. In the years since, the methods have changed in detail and in application, and have differed between the two major pharmacopoeias. 

Gum arabic, under the name of acacia, is the first material in the 11th decennial revision of the Pharmacopoeia of the United States. Other than this description, there is no accepted standard specification. 

USP (United States Pharmacopoeia and National Formulary). Column descriptions of the analysis of specific targeted analytes are provided in Table 2.15. 

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