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.
Pharmacopoeia
29 articles
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
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.
Pharmacopoeia
LOSS ON IGNITION
Determining the percentage of test material that is volatilized & driven off under the conditions specified.
Pharmacopoeia
DEAERATED WATER
Deaerated Water or “degassed water” is Purified Water that has been treated to reduce the content of dissolved air by “suitable means” ...
Pharmacopoeia
HIGH-PURITY WATER
High-Purity Water may be prepared by deionizing previously distilled water and then filtering it through a 0.45-μm rated membrane.
Pharmacopoeia
FILTERED WATER
Filtered Water is Purified Water that has been filtered to remove particles that could interfere with the analysis.
Pharmacopoeia
Loss on Drying (LOD): Formula, Procedure & USP Limits
Loss on drying is the loss of mass after drying under specified conditions, calculated as a percentage (m/m).
Pharmacopoeia
DEIONIZED DISTILLED WATER
This water is used as a reagent in a liquid chromatography test that requires a low ionic or organic impurity level.
Pharmacopoeia
DEIONIZED WATER
Deionized Water is produced by an ion-exchange process in which the cations & anions are replaced with H+ & OH− ions by use of ion-exchange
Pharmacopoeia
DISTILLED WATER
Distilled Water is produced by vaporizing Drinking Water or a higher quality of water and condensing it into a purer state.
Manufacturing and Packaging
CREAMS
Creams are semisolid emulsion dosage forms, Creams are generally intended for external application to the skin or to the mucous membranes
Pharmacopoeia
DRINKING WATER
Drinking Water can be referred to as Potable Water, it may be used in the early stages of cleaning pharmaceutical manufacturing equipment.
Pharmacopoeia
SOURCE WATER CONSIDERATIONS
Source water is the water that enters the facility. a minimum, drinking (potable) water standards as defined by the regulatory.
Pharmacopoeia
Nonmonographed Waters
These waters can also be used in pharmaceutical processing steps & also as a starting material for further purification or testing purposes.
Pharmacopoeia
STERILE WATER FOR IRRIGATION
is Water for Injection packaged and sterilized in single-dose containers that may be larger than 1 L & allow rapid delivery of their content
Pharmacopoeia
BACTERIOSTATIC WATER FOR INJECTION
BWI is Water for Injection, packaged and rendered sterile, to which has been added one or more suitable antimicrobial preservatives.
Pharmacopoeia
Sterile Water for Injection
Sterile Water for Injection is water for Injection packaged and rendered sterile.
Pharmacopoeia
STERILE PURIFIED WATER
Sterile Purified Water is Purified Water, packaged and rendered sterile.
Manufacturing and Packaging
Films PHARMACEUTICAL DOSAGE FORMS
USP-43 〈1151〉 Films PHARMACEUTICAL DOSAGE FORMS
Pharmacopoeia
Capsules PHARMACEUTICAL DOSAGE FORMS
Capsules PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43, Chapter <1151>
General
Pharmaceutical Dosage Forms: Complete Classification List
〈1151〉 PHARMACEUTICAL DOSAGE FORMS This article is based on the requirement of the United State Pharmacopoeia.
Pharmacopoeia
Parenteral Dosage Forms: Types, Requirements & Examples
INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS)—PRODUCT QUALITY TESTS This article is based on the requirement of the United State Pharmacopoeia…