[转]USP历年删除的通则--摘自Admissions

罗伊鲱

Articles Included in USP 23 but Not Included in USP 24
（无）
Articles Included in USP 27 but Not Included in USP 28 (.chm)
（无）
Articles Included in USP 28 but Not Included in USP 29
（无）

Articles Included in USP 29 but Not Included in USP 30
（无）

Articles Included in USP 30 but Not Included in USP 31
<1047> Biotechnology-derived articles

USP 32 Admissions
（无）

Articles Included in USP 34 But Not Included in USP 35
GENERAL CHAPTERS
<521> Sulfonamides
<727> Capillary Electrophoresis
<1101> Medicine Dropper
<1221> Teaspoon
<1070> Emergency Medical Services Vehicles and Ambulances—Storage of Preparations

Articles Included in USP 35 But Not Included in USP 36
GENERAL CHAPTERS
<141> Protein—Biological Adequacy Test
<1150> Pharmaceutical Stability

Articles Included in USP 36 But Not Included in USP 37
<16> Automated Methods of Analysis
<681> Repackaging into Single-Unit Containers and Unit-Dose Containers for Nonsterile Solid and Liquid Dosage Forms
<1146> Packaging Practice—Repackaging a Single Solid Oral Drug Product into a Unit-Dose Container

Articles Included in USP 37 But Not Included in USP 38
GENERAL CHAPTERS
<726> Electrophoresis
<1081> Gel Strength of Gelatin
<1196> Pharmacopeial Harmonization

Articles Included in USP 38 But Not Included in USP 39
GENERAL CHAPTERS
<361> Barbiturate Assay

Articles Included in USP 39 But Not Included in USP 40
GENERAL CHAPTERS
<21> Thermometers
<751> Metal Particles in Ophthalmic Ointments
<851> Spectrophotometry and Light-Scattering
<1035> Biological Indicators for Sterilization
<1045> Biotechnology-Derived Articles
<1209> Sterilization—Chemical and Physicochemical Indicators and Integrators

Articles Included in USP 40 But Not Included in USP 41
GENERAL CHAPTERS
<371> Cobalamin Radiotracer Assay
<1015> Automated Radiochemical Synthesis Apparatus
<1171> Phase-Solubility Analysis

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歪说歪有李

有出口的看过来，顶起！

罗伊鲱

previously proposed as Shipping and Storage of Labile Preparations á 1186 ? (see page 495 of PF 28(2) [Mar.–Apr. 2002]), is canceled

31(2) In-Process Revision: <1225> VALIDATION OF COMPENDIAL PROCEDURES

BRIEFING

<1225> Validation of Compendial Methods, USP 28 page 2748 and page 1382 of PF 30(4) [July–Aug. 2004]. On the basis of comments received, it is proposed to delete the section on Ruggedness because this concept is described under Precision as “intermediate precision.” The term “pharmaceutical products” is replaced with “pharmaceutical articles” to indicate that this chapter applies to both drug substances and drug products (see the USP General Notices). It is also indicated, in Robustness, that robustness may be investigated during method development. In previous revisions, the term “method(s)” was replaced with “procedure(s)” to align with the terms used by the International Conference on Harmonization (ICH). Even though these terms have different meanings throughout USP, it is expected that USP will continue to make this change, where appropriate, in order to harmonize with ICH terminology.

小金库

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