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Subcommittee E55.12 on P…
Subcommittee E55.12 on Process Applications
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Matching Standards Under the Jurisdiction of E55.12 by Status
Active
7 matching standards
E2503-13(2020) Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus
E2656-25 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
-See also WK88645 proposed Reapproval
-See also WK90159 proposed Revision
E2888-12(2025) Standard Practice for Process for Inactivation of Rodent Retrovirus by pH
-See also WK94173 proposed Reapproval
E3042-16(2024) Standard Practice for Process Step to Inactivate Rodent Retrovirus with Triton X-100 Treatment
E3259-22 Standard Practice for Process to Remove Retroviruses by Small Virus Retentive Filters
E3326-22 Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry
E3443-24 Standard Guide for Minimizing the Impact of Stability Testing on Batch Yield of Low Yield Biopharmaceutical Products
Proposed New
2 matching standards
WK64991
Stability of Early Phase Protein Products
WK92237
PAT System Application and Lifecycle Management in Biopharmaceutical Industry
Withdrawn, Replaced
0 matching standards
