China 
Africa 
Explore chapters and articles related to this topic
Bupleurum falcatum in Japan
Published in Sheng-Li Pan, Bupleurum Species, 2006
The Japanese Pharmacopoeia (JP) gives the most basic criteria for quality assessment, providing the origin of the plant, description, identification, purity, and standard values. The JP 14th edition (2001) shows only B. falcatum L. as the original species for Saiko and provides the following purity and various standard values:
Understanding the impact of magnesium stearate variability on tableting performance using a multivariate modeling approach
Published in Pharmaceutical Development and Technology, 2020
Ting Wang, Ahmed Ibrahim, Stephen W. Hoag
Thirteen MgSt lots (Wang et al. 2019) obtained from three sources: Covidien Mallinckrodt (CM), Peter Greven (PG) and Spectrum (S) were used in this study, see Table 1. All products are in accordance with the National Formulary (NF), British Pharmacopoeia which has adopted the European Pharmacopoeia monograph, or Japanese Pharmacopoeia. Microcrystalline cellulose (MCC), dibasic calcium phosphate (DiCal) and lactose were selected as fillers. They are common fillers in direct compression tablet formulations, and they are representatives of plastic, brittle and intermediate materials, respectively. MCC was obtained as Avicel PH-102 (lot#: P211822782) from FMC Corporation (Philadelphia, PA), DiCal was obtained as Emcompress (lot#: 7088) from JRS (Chicago Heights, IL) and spray-dried lactose was obtained as Pharmatose DCL11 (lot#: 10242217) from DMV (DFE Pharma, Goch, Germany).
The need for new control strategies for particulate matter in parenterals
Published in Pharmaceutical Development and Technology, 2019
Johannes Poms, Stephan Sacher, Matthias Nixdorf, Michael Dekner, Sabine Wallner-Mang, Ines Janssen, Johannes G. Khinast, Robert Schennach
Regulatory approval and oversight of the product are established according to national standards. In an attempt to harmonize regulations for the major markets of parenterals and ensure the patient safety, the following definition of particulate matter has been adopted by the U.S. Pharmacopeial Convention USP chapter 〈788〉 (United States Pharmacopeia 2011), European Pharmacopoeia 8th Edition Ph. Eur. chapter 2.9.20 (European Pharmacopoeia 2016) and the Japanese Pharmacopoeia JP Chapter 6.07 (The Japanese Pharmacopoeia 16th Edition 2015):‘Particulate matter in injections and parenteral infusions consist of extraneous mobile undissolved particles, other than gas bubbles, unintentionally present in the solutions.’
Pharmaceutical quantification with univariate analysis using transmission Raman spectroscopy
Published in Drug Development and Industrial Pharmacy, 2019
Rie Shimamura, Tatsuo Koide, Hiroshi Hisada, Motoki Inoue, Toshiro Fukami, Noriko Katori, Yukihiro Goda
The quantitative assay of acetaminophen in model tablets by UV–vis spectrophotometry was performed according to the method in the Japanese Pharmacopoeia. Briefly, the model tablets were dissolved in a water/methanol (1:1) mixture at an approximate concentration of 0.2 mg/100 ml. The absorbance of acetaminophen was measured at a wavelength of 244 nm with a V-630 UV-Vis spectrophotometer (JASCO Corp., Tokyo, Japan) using purified water as a blank. The path length of the sample cell was 1.0 cm. The content of acetaminophen in the tablet was calculated using a calibration curve of bulk acetaminophen.