News and Updates
Shutdown of European Pharmacopoeia 10th Edition
European Pharmacopoeia (Ph. Eur.) 10th Edition has been obsolete since 1 January 2023. all previous versions are no longer been accessible.
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117 articles · page 4 of 10
News and Updates
ICH Q9(R1) Quality Risk Management: Summary & Changes
Intended to provide guidance on the principles & examples of tools for quality risk management that can be applied to different aspects...
Manufacturing and Packaging
FDA Dosage & Administration Labeling Guidance — Docket No.
Draft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
News and Updates
New paragraph on control of N-nitrosamines, Ph. Eur. revised General Monograph 2034 and 2619
Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of a new paragraph on control of N-nitrosamines
Pastes
Pastes are semisolid preparations of stiff consistency and contain a high percentage 20%–50% of finely dispersed solids. Pastes are intended for
Manufacturing and Packaging
WHO TRS 1044 (2022): 56th Report Annexes & PDF
WHO Expert Committee on Specifications for Pharmaceutical Preparations has published the Technical Report Series TRS 1044 2022 56th Report
Pharmacopoeia
Signal to noise ratio: revision of Ph. Eur. general chapter Chromatographic separation techniques
Ph. Eur. users are advised to continue calculating the S/N ratio on a window “at least 5 x Wh”, instead of “20 x Wh”.
News and Updates
Revised general chapter on rubber closures published in the Ph. Eur. Supplement 11.1
EDQM revised general chapter on Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders
Pharmacopoeia
IMPLANTS
Implants are long-acting dosage forms that provide continuous release of the drug substance often for periods of months to years
Pharmacopoeia
OTHER NONMONOGRAPHED WATERS
In addition to Drinking Water, these waters with various other designations. These include waters of various quality levels...
Pharmacopoeia
WATER FOR BACTERIAL ENDOTOXINS TEST
WATER FOR BACTERIAL ENDOTOXINS TEST is also referred as Limulus Amebocyte Lysate (LAL) Reagent Water.
Pharmacopoeia
Pharmaceutical Dosage Form - Gums
Medicated gum is a pliable dosage form that is designed to be chewed rather than swallowed. it Release the drug substances into the saliva.