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Impurities, drug guidelines

Structural information of stress-induced degradation products can also be used to assess the potential for formation of toxic degradation products. Both ICH guidelines on impurities (drug substance and drug product) specifically address the issue of potential toxic impurities ... [Pg.36]

HHS/FDA International Conference on Harmonisation, Guidelines Availability Impurities in New Drug Substances Notice, Federal Register, January 4, 1996 An FDA Perspective on Bulk Pharmaceutical Chemicals, Edmund M. Fry, Pharmaceutical Technology, February 1984, Pages 48-53... [Pg.285]

Some internationally harmonized guidelines regarding specifications and tests, impurities and validation of analytical methods have particular relevance to the development of chiral drugs and are discussed below. In addition, the impact of work on the common technical document is considered. [Pg.333]

The guideline on impurities in new medicinal products parallels the drug substance text, but the designated thresholds concern only degradation products. The thresholds should be applied to the product at the end of its shelf-life, as that is when the greatest level of degradation is expected to have occurred. [Pg.336]

The guideline states that the objective of validation is to demonstrate that an analytical method is fit for its purpose and summarizes the characteristics required of tests for identification, control of impurities and assay procedures (Table 13-2). As such, it applies to chiral drug substances as to any other active ingredients. Requirements for other analytical procedures may be added in due course. [Pg.337]

Validation of analytical procedures methodology Guideline on Impurities in New Drug Substances Guideline on Impurities in New Drug Products Availability Notice... [Pg.76]

ICH Guideline Q3A(R) Impurities in New Drug Substances (revised guideline), 2002. http //www.ich.org/pdfICH/Q3ARStep4.pdf... [Pg.188]

See other pages where Impurities, drug guidelines is mentioned: [Pg.436]    [Pg.3799]    [Pg.187]    [Pg.830]    [Pg.263]    [Pg.325]    [Pg.331]    [Pg.335]    [Pg.336]    [Pg.336]    [Pg.336]    [Pg.254]    [Pg.334]    [Pg.340]    [Pg.344]    [Pg.345]    [Pg.345]    [Pg.345]    [Pg.693]    [Pg.287]    [Pg.312]    [Pg.7]    [Pg.134]    [Pg.149]    [Pg.274]    [Pg.287]    [Pg.290]    [Pg.340]    [Pg.348]    [Pg.360]    [Pg.376]    [Pg.452]    [Pg.452]    [Pg.452]    [Pg.453]   
See also in sourсe #XX -- [ Pg.325 , Pg.329 , Pg.335 ]

See also in sourсe #XX -- [ Pg.325 , Pg.329 , Pg.335 ]



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Drug impurities

Drugs guidelines

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