Title 40

SECTION 160.135

160.135 Physical and chemical characterization studies.

§ 160.135 Physical and chemical characterization studies.

(a) All provisions of the GLP standards 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) of test, control, or reference substances.

(b) The following GLP standards shall not apply to studies, other than those designated in paragraph (a) of this section, designed to determine physical and chemical characteristics of a test, control, or reference substance:

§ 160.31 (c), (d), and (g) § 160.35 (b) and (c) § 160.43 § 160.45 § 160.47 § 160.49 § 160.81(b) (1), (2), (6) through (9), and (12) § 160.90 § 160.105 (a) through (d) § 160.113 § 160.120(a) (5) through (12), and (15) § 160.185(a) (5) through (8), (10), (12), and (14) § 160.195 (c) and (d)

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