Standards compendia

Final identification may be possible by comparison with an authentic spectrum of cyclopropanecarboxylic acid, if it is available in one of the several standard compendia of infrared spectra. A total of about 150,000 infrared spectra are available for comparison purposes. You should check with the reference section of your library to see what atlases of spectral data are available to you. 

Research the type of additives and normal concentrations. Learn about their properties. Do they have a unique element or chemical tag that can be used for quantitative measurements Is an analysis method available from the supplier or in the literature Many sources are available scientific journals, trade journals, technical application sheets from instrument manufacturers and standards compendia. Any method selected must be validated in your own laboratory. Learn as much as possible about the polymer matrix. Thermoplastics can be hot pressed into thin films. Many polymers are solvent resistant, so extraction techniques can be used to isolate the additives. 

The CnitedSfates Pharmacopeia (USP) and the Hationa/Pormu/aTy (NP) ate the recognized standards for potency and purity for most common dmg products. The USP was first pubflshed in 1833 the NP in 1887. Upon adoption of the first Pood and Dmg Act in 1906 these compendia became official, ie, they pubflsh the legal standards of quaUty, purity, and strength. The 1980 editions of USP(XX) and NP(XV) were combined for the first time revisions take place every five years. USPXXIII/NFXVIII is effective as of 1995. 

The 2000 U.S. Pharmacopoeia and National Formulary, USP 24-NF 19, was published in October 1999. It became official on 01.01.2000. USP-NF is one of, if not the most, widely recognized of the world s pharmacopoeial compendia of standards for drug strength, quality, purity, packaging, labelling and storage. USP-NF also provides standards for devices and diagnostics, as well as nutritional supplements. 

Several guidelines are available in the literature for the pharmacist who must extemporaneously prepare an ophthalmic solution. The USP contains a section on ophthalmic solutions, as do other compendia and several standard textbooks. Since the pharmacist does not have the facilities to test the product, he or she should dispense only small quantities, with an expiration date of no more than 30 days. Refrigeration of the product should also be required as a precautionary measure. To reduce the largest potential source of microbial contamination, only sterile purified water should be used in compounding ophthalmic solutions. Sterile water for injection, USP, from unopened IV bottles or vials is the highest-quality water available to the pharmacist. Prepackaged sterile water with bacteriostatic agents should not be used. 

Trade associations and the compendia also played an important role in drug product control and quality during the nineteenth and twentieth centuries. The United States Pharmacopeia (USP) and National Formulary (NF) established standards of potency and... 

The standards for pharmaceutical chemicals and their respective dosage forms, as laid down in, various Official Compendia fulfd broadly the following three cardinal objectives, namely ... 

Technical information based on in vivo standards and specifications are generally incorporated in various official compendia. Hence, in order to record a legitimate assessment of bioavailability, in vivo test is an absolute necessity and the relative data obtained therefrom should form an integral part of the standard specifications in the offcial standard. 

Various official compendia specifies a standard temperature (°C) for glass volumetric apparatus as mentioned hereunder ... 

Various Official Compendia viz., IP, BP, USP, NF and NBS (National Bureau of Standards) have laid down tolerance on capacity for Burettes, Pipettes, Volumetric Flasks. Discuss its importance in volumetric quantitative analysis. 

The requirements for light absorption in the official compendia invariably apply to the dried, anhydrous, or solvent free material in all such monographs in which standards for loss on drying, water or solvent content are provided. 

A plethora of pure drugs, their respective combinations and their dosage forms have been assayed by NMR-spectroscopy quantitatively by various researchers and the result(s) thus obtained were duly verified and compared with the standard methods prescribed in various official compendia. A few typical examples of such drugs shall be described briefly here ... 

Part—I has three chapters that exclusively deal with General Aspects of pharmaceutical analysis. Chapter 1 focuses on the pharmaceutical chemicals and their respective purity and management. Critical information with regard to description of the finished product, sampling procedures, bioavailability, identification tests, physical constants and miscellaneous characteristics, such as ash values, loss on drying, clarity and color of solution, specific tests, limit tests of metallic and non-metallic impurities, limits of moisture content, volatile and non-volatile matter and lastly residue on ignition have also been dealt with. Each section provides adequate procedural details supported by ample typical examples from the Official Compendia. Chapter 2 embraces the theory and technique of quantitative analysis with specific emphasis on volumetric analysis, volumetric apparatus, their specifications, standardization and utility. It also includes biomedical analytical chemistry, colorimetric assays, theory and assay of biochemicals, such as urea, bilirubin, cholesterol and enzymatic assays, such as alkaline phosphatase, lactate dehydrogenase, salient features of radioimmunoassay and automated methods of chemical analysis. Chapter 3 provides special emphasis on errors in pharmaceutical analysis and their statistical validation. The first aspect is related to errors in pharmaceutical analysis and embodies classification of errors, accuracy, precision and makes... 

Once the appropriate dissolution conditions have been established, the method should be validated for linearity, accuracy, precision, specificity, and robustness/ruggedness. This section will discuss these parameters only in relation to issues unique to dissolution testing. All dissolution testing must be performed on a calibrated dissolution apparatus meeting the mechanical and system suitability standards specified in the appropriate compendia. 

US Pharmacopoeia 29 and National Formulary 24, The Official Compendia of Standards, 2006. 

It is a good idea, when using such simple Nernst plots as an analytical method of determining an activity, to check that the intercept at jc = 0 is indeed the standard electrode potential. (There are many compendia listed in the Bibliography at the end of this book that cite large numbers of values, as does Appendix 3.)... 

The pharmacopeias have worked with the ICH process to facilitate the international environment of pharmaceutical research and product registration. On the other hand, the additional situation for compendia is that the standards which they have published now apply to all of the already marketed products. In that case a company has testing history and product history in their quality control departments. These are the most conservative elements within the pharmaceutical industry as is necessary to their task. Quality control departments are reluctant to change methods when they feel that their products are properly represented by the current of tests. Therefore, a tension is ereated between trying to develop harmonized standards, which facilitate one area of activity in the world of pharmaeeutieals, and not disturbing a satisfactory marketplace. A vast amount of progress has been made in the harmonization of phar-maeopeial methods. 

Experimental compendia of vibrational frequencies include (a) T. Shinanouchi, Tables of Molecular Vibrational Frequencies. Consolidated Volume I, NSRDS-NBS 39, National Bureau of Standards, Washington, D.C., 1972, and following volumes in this series (b) K.R Huber and GHerzberg, Molecular Spectra and Molecular Structure. IV. Constants for Diatomic Molecules, Van Nostrand Reinhold, New York, 1979 (c) M.W. Chase, Jr., NIST-JANAF Thermochemical Tables, 4th Ed., National Institute of Standards and Techonology, Washington, D C., 1998. 

The amount and level of contaminants or impurities in water for pharmaceutical purpose depend on its use. Since water is used in all industries and scientific work, international and national standard authorities have established water quality parameters for all types of applications. Health-related water standards are given by organizations such as the World Health Organization (WHO) [2], the Environmental Protection Agency (EPA) [3], and the American Society for Testing and Materials Standards (ASTM) [4] in the United States and by pharmacopeial compendia when the aim is specifically related to water for pharmaceutical products for human and veterinary consumption. 

Limits for DEFIP in formulations stored in PVC bags are not set in pharmaco-peial compendia. The BP prescribes a standard test whose results should show that the amount of DEFIP extracted by action of ether on PVC bags does not exceed 40% of the polymer mass. This test is valid for PVC for all uses Dry dosage forms, noninjectable aqueous solutions, intravenous aqueous infusions, blood and blood components, and tubing used in sets for blood and blood components. On the other... 

U.S. Pharmacopeia/National Formulary (2005), The Official Compendia of Standards, USP 28/NF23, U.S. Pharmacopeial Convention, Rockuille, Maryland. 

United States Pharmacopeia, General Chapters Physical Tests and Determinations <711 > Dissolution, Official Compendia of Standards, USP 25, NF 20, p. 2011, 2002. 

All compendias [5-7] specify use of a liquid chromatographic method to determine the eight known rocuronium bromide impurities. The chromatographic method corresponds to the chromatographic method used to determine rocuronium in bulk drug substance, as detailed in Section 2.3.1. For the purpose of analyzing impurities, the RS used is the RS of rocuronium that is intended for peak identification, where the identification standard contains impurities of rocuronium bromide and rocuronium bromide itself. 

If the ICH guideline is to reach its objective of reducing the unnecessary duplication of efforts and speed up the review process, revision of the guideline is of course necessary and the use of broad qualifiers such as "similar" must be replaced by definite standards as is common in all compendia. 

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