rule 121A
Authority for the purpose of carrying out the test on its behalf.
The Drugs and Cosmetics Act and RulesHealth240 of 130 rules available2 chapters
Part X SPECIAL PROVISIONS RELATING TOBIOLOGICAL AND
Statutory text
Test for pyrogens–Solution of substances intended for parenteral administration in large volumes (10 ml or more at a time) shall be pyrogen-free and tested for pyrogens. If water or any other aqueous solvent is supplied along with the substances for preparing such solutions, it shall also be pyrogen-free and tested for pyrogens.
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