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ANNOTATED LIST
General Notices, Monographs, General Chapters, Reagents, and Tables Affected by Changes Appearing in NF 30
Page citations refer to the pages of NF 30. Note—In the list below, if a section is new or if a subsection is added to or deleted from an existing section, it is labeled as such in parentheses after the section or subsection name. Items on this list that appear without the designation “new,” “added,” or “deleted” are items in which changes have been made to existing official text.
Excipients
Coating Agent
Ethylcellulose Dispersion Type B Methacrylic Acid and Ethyl Acrylate Copolymer Dispersion
Emulsifying and/or Solubilizing Agent
Polyglyceryl Dioleate
Film-Forming Agent
Ammonio Methacrylate Copolymer Ethylcellulose Dispersion Type B Methacrylic Acid and Ethyl Acrylate Copolymer Dispersion
Humectant
Hydrogenated Starch Hydrolysate
Sweetening Agent
Hydrogenated Starch Hydrolysate
Tablet Binder
Hydrogenated Starch Hydrolysate
Tablet and/or Capsule Diluent
Hydrogenated Starch Hydrolysate
Monographs (NF 30)
Agar CHEMICAL INFORMATION DEFINITION IDENTIFICATION Test A (added) Test B Test C IMPURITIES Organic Impurities (subsection Procedure 3) SPECIFIC TESTS Microbial Enumeration Tests and Tests for Specified Microorganisms Botanic Characteristics (subsections Agar and Histology) ADDITIONAL REQUIREMENTS Packaging and Storage (added) USP Reference Standards (added) Ammonio Methacrylate Copolymer CHEMICAL INFORMATION DEFINITION IDENTIFICATION Test B ASSAY Procedure (subsection Analysis) IMPURITIES Procedure: Limit of Monomers (subsections Standard solution, Sample solution, System suitability, and Acceptance criteria) SPECIFIC TESTS Viscosity (subsections Analysis and Acceptance criteria) Diethylene Glycol Monoethyl Ether ASSAY Procedure (subsection Sample) ADDITIONAL REQUIREMENTS Labeling Ethylcellulose Dispersion Type B (new) Lactobionic Acid ASSAY Procedure (subsections Sample and Analysis) Magnesium Stearate IMPURITIES Chloride and Sulfate Lead (deleted) Limit of Cadmium (added) Limit of Lead (added) Limit of Nickel (added) SPECIFIC TESTS Relative Content of Stearic Acid and Palmitic Acid (subsections Chromatographic system and System suitability) ADDITIONAL REQUIREMENTS Labeling Methacrylic Acid Copolymer Dispersion IDENTIFICATION Test B ASSAY Procedure (subsection Titrimetric system and Analysis) IMPURITIES Limit of Monomers (subsections Sample solution and System suitability) SPECIFIC TESTS Microbial Enumeration and Tests for Specified Microorganisms (added) ADDITIONAL REQUIREMENTS USP Reference Standards Methacrylic Acid and Ethyl Acrylate Copolymer Dispersion (new) Polyglyceryl Dioleate (new) Hydrogenated Starch Hydrolysate (new) Stearic Acid DEFINITION IDENTIFICATION Test A (added) Test B (added) Test C (added) ASSAY Procedure SPECIFIC TESTS Congealing Temperature (deleted) Fats and Fixed Oils Mineral Acid (deleted) Neutral Fat or Paraffin (deleted) Color of Solution (added) Acidity (added) Freezing Point (added) ADDITIONAL REQUIREMENTS Labeling Sucrose IMPURITIES Residue on Ignition (deleted) Chloride and Sulfate, Chloride (deleted) Chloride and Sulfate, Sulfate (deleted) Calcium (deleted) Heavy Metals (deleted) Sulfite (added) SPECIFIC TESTS Appearance of Solution (added) Conductivity (added) Optical Rotation (subsection Acceptance criteria) Color Value (added) Dextrins (added) Reducing Sugars (added) Loss on Drying (added) Bacterial Endotoxins (added) Invert Sugar (deleted) ADDITIONAL REQUIREMENTS Labeling (added) Zein IDENTIFICATION Test C IMPURITIES Organic Impurities (added) SPECIFIC TESTS Protein Content (subsection Acceptance criteria) ADDITIONAL REQUIREMENTS Labeling (added) |