Title 40

SECTION 792.135

792.135 Physical and chemical characterization studies.

§ 792.135 Physical and chemical characterization studies.

(a) All provisions of the GLPs shall apply to physical and chemical characterization studies designed to determine stability, solubility, octanol water partition coefficient, volatility, and persistence (such as biodegradation, photodegradation, and chemical degradation studies).

(b) The following GLP standards shall not apply to studies designed to determine physical and chemical characteristics of a test, control, or reference substance:

Section 792.31 (c), (d), and (g) Section 792.35 (b) and (c) Section 792.43 Section 792.45 Section 792.47 Section 792.49 Section 792.81(b) (1), (2), (6) through (9), and (12) Section 792.90 Section 792.105 (a) through (d) Section 792.113 Section 792.120(a) (5) through (12), and (15) Section 792.185(a) (5) through (8), (10), (12), and (14) Section 792.195 (c) and (d)

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