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: References

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

Índice de contenido

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

References

1. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Twenty-fifth report. Geneva, World Health Organization, 1975, Annex 3 (WHO Technical Report Series, No. 567).

2. The international pharmacopoeia, 3rd ed. Vol. 1. General methods of analysis; Vol. 2. Quality specifications; Vol. 3. Quality specifications; Vol. 4. Tests, methods, and general requirements. Quality specifications for pharmaceutical substances, excipients, and dosage forms. Geneva, World Health Organization, 1979-1994.

3. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Twenty-eighth report. Geneva, World Health Organization, 1982, Annex 1 (WHO Technical Report Series, No. 681).

4. Good laboratory practices in governmental drug control laboratories. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirtieth report. Geneva, World Health Organization, 1987, Annex 1 (WHO Technical Report Series, No. 748).

5. Good manufacturing practices for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992, Annex 1 (WHO Technical Report Series, No. 823).

6. Good manufacturing practices for biological products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-third report. Geneva, World Health Organization, 1993, Annex 3 (WHO Technical Report Series, No. 834).

7. General recommendations for the preparation and use of infrared spectra in pharmaceutical analysis. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fourth report. Geneva, World Health Organization, 1996, Annex 4 (WHO Technical Report Series, No. 863).