Search results with tag "Pharmaceutical preparations"
5.1.4. MICROBIOLOGICAL QUALITY OF PHARMACEUTICAL …
uk.vwr-cmd.comof pharmaceutical preparations, suitable measures must be taken to ensure their microbiological quality. The pharmaceutical preparations should comply with the criteria given below. Category 1 Preparations required to be sterile by the relevant monograph on the dosage form and other preparations labelled sterile. — Test for sterility (2.6.1 ...
Type I Glass for Pharmaceutical Containers: Technical ...
www.dcvmn.org“When glass containers for pharmaceutical use are manufactured under stressed conditions (e.g. temperature time profile) and/or are placed in contact with particularly aggressive pharmaceutical preparations, they may give rise to delamination, i.e. the separation of the inner glass surface into layers, called lammellae or flakes.
WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR …
www.who.intPHARMACEUTICAL PREPARATIONS Forty-fourth report WHO Technical Report Series 957 ... Pharmaceutique — European Association of Pharmaceutical Full-line Wholesalers 4 ... 3.1 The International Pharmacopoeia 16 3.2 Current work plan and future work programme 19
5.1.4. MICROBIOLOGICAL QUALITY OF PHARMACEUTICAL …
uspbpep.com5.1.4. Microbiological quality of pharmaceutical preparations EUROPEAN PHARMACOPOEIA 6.0 B. Herbal medicinal products to which boiling water is not added before use. — Total viable aerobic count (2.6.12).Not more than 105 bacteria and not more than 104 fungi per gram or per millilitre. —Notmorethan103 enterobacteria and certain other gram-negative bacteria per gram or per millilitre
BRIEFING 660 Containers Glass, - U.S. Pharmacopeia
www.usp.orgpharmaceutical preparations, and the quality of this surface is determined by the Surface Glass Test. for hydrolytic resistance 1S (USP41) The Surface Etching Test may be used to determine whether the high hydrolytic resistance is due to chemical composition or due to ammonium sulfate 1S (USP41) surface treatment.
Annex 2 WHO good manufacturing practices: water for ...
www.who.int72 WHO Technical Report Series No. 970, 2012 WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-sixth report 3.4.2 BHPW should also be protected from recontamination and microbial proliferation. 3.4.3 BHPW and WFI have identical microbiological requirements. 3.5 Bulk water for injections 3.5.1 Bulk water for injections (BWFI) should be …
Annex 6 WHO good manufacturing practices for sterile ...
www.who.int2.5 The use of rapid microbiological methods to replace the traditional ... quality of, for example, water, the environment or bioburden, could be considered if appropr iately val idated and if a comparat ive assessment of the ... 4.3 For the manufacture of sterile pharmaceutical preparations, four ...
Pharmaceutical Calculations - Jones & Bartlett Learning
samples.jbpub.comPharmaceutical Preparations—administration & dosage—Problems and Exercises. QV 18.2] RS57 615.1’4076–dc23 2014023058 6048 Printed in the United States of America 18 17 16 15 14 10 9 8 7 6 5 4 3 2 1 9781449685362_FMxx_Printer.indd 2 23/08/14 12:34 AM. This textbook is dedicated to: ...
PHARMACEUTICAL PREPARATIONS - WHO
www.who.int5 The InTernaTIonal PharmacoPoeIa The International Pharmacopoeia is a collection of quality specifications for pharmaceutical substances (active …
PHARMACEUTICAL PREPARATIONS - WHO
www.who.intpharmacopoeial quality has been used to produce the dosage form being tested. The limits set for degradation impurities in dosage form monographs depend on a number of general considerations. For example, such limits may need to be higher than those for the same impurities in the corresponding API
Similar queries
MICROBIOLOGICAL QUALITY OF PHARMACEUTICAL, Of pharmaceutical preparations, Microbiological quality, PHARMACEUTICAL PREPARATIONS, Preparations, PHARMACEUTICAL, COMMITTEE ON SPECIFICATIONS FOR, European, Pharmacopoeia, Microbiological, Quality, Pharmaceutical Calculations, Substances, Active, Pharmacopoeial, Dosage