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Physicochemical potency assay

The establishment of a physicochemical potency assay for biosynthetic human growth hormone provides an interesting example of an approach for validation of such assays. The hypophysectomized rat growth promoting assay used tradionally has a precision of approximately 15-20% RSD, which is clearly not adequate for controlling well-characterized products. In order to select a suitable assay to replace the in-vivo bioassay, the biopotencies... [Pg.122]

All product characteristics likely to be affected by storage, e.g., assay value or potency, content of products of decomposition, physicochemical properties (hardness, disintegration, particulate matter, etc.), should be determined for solid or semi-solid oral dosage forms, dissolution tests should be carried out... [Pg.122]

See other pages where Physicochemical potency assay is mentioned: [Pg.704]    [Pg.707]    [Pg.96]    [Pg.10]    [Pg.321]    [Pg.181]    [Pg.185]    [Pg.199]    [Pg.83]    [Pg.22]    [Pg.264]    [Pg.388]    [Pg.143]    [Pg.122]    [Pg.351]    [Pg.418]    [Pg.439]    [Pg.452]    [Pg.89]    [Pg.18]    [Pg.102]    [Pg.103]    [Pg.345]    [Pg.403]    [Pg.380]    [Pg.213]    [Pg.6]    [Pg.111]    [Pg.121]    [Pg.1606]    [Pg.56]    [Pg.51]    [Pg.283]    [Pg.101]    [Pg.103]    [Pg.141]    [Pg.77]    [Pg.253]    [Pg.45]    [Pg.250]    [Pg.45]    [Pg.72]    [Pg.340]    [Pg.458]    [Pg.738]    [Pg.426]   
See also in sourсe #XX -- [ Pg.123 ]



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Physicochemical assays

Potency

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