Essential Elements for a GMP Analytical Chemistry Department by Thomas Catalano

Author:Thomas Catalano
Language: eng
Format: epub
Publisher: Springer New York, New York, NY

Table 3.23Topical drug products—investigational phase 1 and 2 (Includes topical creams, ointments, and gels)

Test procedure

Registration acceptance criteria

Internal acceptance criteria

Comments

Assay

95.0–105.0 % of label

95.0–105.0 % of label

Shelf life limit may be broader, with supporting data. Justification of a broader time of release limit may also be possible. A limit of 90.0–110.0 % of label is usually acceptable for the U.S. A limit of 95.0–105.5 % of label is expected for the EU

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