Proposed New USP General Information Chapter, Excipient Performance h1059i Gregory E. Amidon, PhD, Chair, Excipient General Chapters Expert Committee, Garnet E. Peck, PhD, Vice Chair, Excipient General Chapters Expert Committee, Lawrence H. Block, PhD, Chair, Excipient Monographs 2 Expert Committee, Richard C. 2011 USP 34 NF 29 3-Volume Set (U.S. Pharmacopeia National Formulary. Using USP-NF monographs and methods can help to Ensure compliance with.

Type of Posting: Notice of Adoption of Harmonized Standard Posting Date: 25–Feb–2011 (updated 27–Feb–2017*) Official Date: 01–Dec–2011 Expert Committee: Monographs—Excipients *Coordinating Pharmacopeia: EP A harmonized standard for Crospovidone has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the Crospovidone monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts. Changes from the existing USP–NF monograph include: • Changed Definition from Anhydrous basis to Dried Basis. Amended to include Type A or Type B, determined by particle size.

• Added tests for Identification C and D. Periya veettu panakkaran tamil movie mp3. Added new test to distinguish between Type A and Type B using wet sieving. • Changed Assay acceptance criteria from anhydrous basis to dried basis. • Changed Residue on Ignition specification from 0.4% to 0.1%.

• Added Peroxides test. • Changed Vinylpyrrolidinone test from titration to HPLC. • Deleted pH test.

• Replaced Water Determination test with Loss on Drying. • Updated significant figures in Water-Soluble Substances Acceptance criteria from 1.50 to 1.5%. • Added Labeling requirement that the label states as Type A or Type B. The Crospovidone monograph will be incorporated into and become official with the Second Supplement to USP 34–NF 29. *Should you have any questions about the Crospovidone monograph, please contact Dr. Tong (Jenny) Liu (240-221-2072 or ).

For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or ). *The previous PDG sign-off Cover Pages and Stage 6 postings are included as below: • – Stage 6 • Download the Crospovidone PDG Sign-Off Cover Page: •.

Type of Posting: Notice of Adoption of Harmonized Standard Posting Date: 27–Apr–2018 Official Date: 01–May–2019 Expert Committee: Excipient Monographs 2 Coordinating Pharmacopeia: Japanese Pharmacopoeia The revision to the harmonized standard for Hypromellose has been approved by the Pharmacopeial Discussion Group (PDG) as described in its. Having reached Stage 4 (former Stage 6) of the PDG process, the Hypromellose monograph has been formally approved by the Excipient Monographs 2 Expert Committee in accordance with the Rules and Procedures of the Council of Experts. The changes from the current Hypromellose monograph include: • Assay • In the Sample solution preparation procedure, change from “If the weight loss is ≥0.5% of the contents or ” to “If the weight loss is ≥26 mg or ” based on the inability to calculate a percentage deviation from its contents. The weight loss is based on the mass of the contents, and not on the total mass of the apparatus, plus the contents. Cadillacs and dinosaurs 20 gun hack apk download. • In the GC analysis, replace the packed GC column with a capillary GC column.