Reference Substances and Infrared Reference Spectra for Pharmacopoeial Analysis (WHO Technical Report Series, No. 885, 1999: Annex 3): 2. General guidelines for the establishment, maintenance and distribution of chemical reference substances - Reprint from WHO Technical Report Series, No. 885, 1999: Annex 3: Part A. Primary chemical reference substances: 3. Evaluation of chemical reference substances: 3.4 Use in the calibration of an instrument

Reference Substances and Infrared Reference Spectra for Pharmacopoeial Analysis (WHO Technical Report Series, No. 885, 1999: Annex 3)
(1999; 117 pages)

Table des matières

Preface¹
1. Compilation of national, regional and international reference substances and infrared reference spectra
	1.1 Reference substances for pharmacopoeial analysis
		Addresses for the purchase or the source of reference substances
		List of reference substances
	1.2 Infrared reference spectra for pharmacopoeial
		Addresses for the purchase or the source of reference spectra
		List of infrared reference spectra
2. General guidelines for the establishment, maintenance and distribution of chemical reference substances - Reprint from WHO Technical Report Series, No. 885, 1999: Annex 3
	Introduction
	Part A. Primary chemical reference substances
		1. Assessment of need for the establishment of chemical reference substances
		2. Obtaining source material
		3. Evaluation of chemical reference substances
			3.1 Use in identification tests
			3.2 Use in purity tests
			3.3 Use in assays
			3.4 Use in the calibration of an instrument
		4. Chemical and physical methods used in evaluating chemical reference substances
			4.1 Methods used to verify the identity of chemical reference substances
			4.2 Methods used to determine the purity of chemical reference substances
				4.2.1 Separation techniques
				4.2.2 Methods based on intrinsic thermodynamic properties
				4.2.3 Other methods
		5. Assignment of content
		6. Handling and distribution of chemical reference substances
			6.1 Packaging operations
			6.2 Storage
			6.3 Stability
			6.4 Information to be supplied with chemical reference substances
			6.5 Distribution and supply
			6.6 Period of use
	Part B. Secondary chemical reference substances
	References
Back cover

3.4 Use in the calibration of an instrument

Where the chemical reference substance is to be employed as calibration material, the extent of testing is similar to that for a chemical reference substance used in assays. Several laboratories should collaborate in testing the proposed substance using a variety of techniques to check that its purity is adequate. An appropriate number of collaborating laboratories should also participate, after the reference substance has been deemed suitable, to establish a value for the essential property of the substance using an appropriate instrument.