Guidance on Handling of Insoluble Matter and Foreign ...

APIC Guidance on Insoluble Matter and Foreign Particles in APIs Page 6 of 19 2.2 Background The United States FD&C Act - Subchapter A - SEC.501.[351]b) states that a drug or device shall be deemed to be adulterated - (a)(1) if it consists in whole or in part of any filthy, putrid, or decomposed substance; or

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EUROPEAN PHARMACOPOEIA 5.3 INDEX

EUROPEAN PHARMACOPOEIA 5.3 INDEX To aid users the index includes a reference to the supplement where the latest version of a text can be found. For example: Acetone.....5.1-2875 means the monograph Acetone can be found on page 2875 of Supplement 5.1.