News and UpdatesShutdown 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
38 articles
News and Updates
News and UpdatesNew 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
Manufacturing and PackagingPastes
Pastes are semisolid preparations of stiff consistency and contain a high percentage 20%–50% of finely dispersed solids. Pastes are intended for
PharmacopoeiaSignal 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 UpdatesRevised 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
PharmacopoeiaIMPLANTS
Implants are long-acting dosage forms that provide continuous release of the drug substance often for periods of months to years
PharmacopoeiaOTHER NONMONOGRAPHED WATERS
In addition to Drinking Water, these waters with various other designations. These include waters of various quality levels...
PharmacopoeiaWATER FOR BACTERIAL ENDOTOXINS TEST
WATER FOR BACTERIAL ENDOTOXINS TEST is also referred as Limulus Amebocyte Lysate (LAL) Reagent Water.
PharmacopoeiaPharmaceutical 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.
PharmacopoeiaAMMONIA FREE WATER
AMMONIA FREE WATER From a functional standpoint, Ammonia Free Water must have a negligible ammonia concentration to avoid interference in tests sensitive
PharmacopoeiaOXYGEN FREE WATER
OXYGEN FREE WATER Oxygen-Free Water is Purified Water that has been treated to remove or reduce dissolved oxygen. Such treatment could involve deaerating
PharmacopoeiaLOSS ON IGNITION
Determining the percentage of test material that is volatilized & driven off under the conditions specified.
PharmacopoeiaDEAERATED WATER
Deaerated Water or “degassed water” is Purified Water that has been treated to reduce the content of dissolved air by “suitable means” ...
PharmacopoeiaHIGH-PURITY WATER
High-Purity Water may be prepared by deionizing previously distilled water and then filtering it through a 0.45-μm rated membrane.
PharmacopoeiaFILTERED WATER
Filtered Water is Purified Water that has been filtered to remove particles that could interfere with the analysis.
PharmacopoeiaLoss 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).
PharmacopoeiaDEIONIZED DISTILLED WATER
This water is used as a reagent in a liquid chromatography test that requires a low ionic or organic impurity level.
PharmacopoeiaDEIONIZED 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
PharmacopoeiaFRESHLY DISTILLED WATER
FRESHLY DISTILLED WATER Freshly Distilled Water or “recently distilled water” is produced in the same manner as Distilled Water and should be used soon
PharmacopoeiaDISTILLED WATER
Distilled Water is produced by vaporizing Drinking Water or a higher quality of water and condensing it into a purer state.
PharmacopoeiaCARBON DIOXIDE-FREE WATER
Carbon dioxide-free water is defined in the Reagents, Indicators, and Solutions section of USP–NF as Purified Water that has been vigorously boiled for
Manufacturing and PackagingLOTIONS
LOTIONS Lotions are an emulsified liquid dosage form intended for external application to the skin. Historically, some topical suspensions such as
Manufacturing and PackagingCREAMS
Creams are semisolid emulsion dosage forms, Creams are generally intended for external application to the skin or to the mucous membranes
PharmacopoeiaDRINKING WATER
Drinking Water can be referred to as Potable Water, it may be used in the early stages of cleaning pharmaceutical manufacturing equipment.
PharmacopoeiaSOURCE WATER CONSIDERATIONS
Source water is the water that enters the facility. a minimum, drinking (potable) water standards as defined by the regulatory.
PharmacopoeiaNonmonographed Waters
These waters can also be used in pharmaceutical processing steps & also as a starting material for further purification or testing purposes.
PharmacopoeiaSTERILE WATER FOR INHALATION
STERILE WATER FOR INHALATION is Water for Injection that is packaged and rendered sterile and is intended for use in inhalators and in the preparation of
Manufacturing and PackagingSTERILE 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
Manufacturing and PackagingBACTERIOSTATIC WATER FOR INJECTION
BWI is Water for Injection, packaged and rendered sterile, to which has been added one or more suitable antimicrobial preservatives.
Manufacturing and PackagingSterile Water for Injection
Sterile Water for Injection is water for Injection packaged and rendered sterile.
PharmacopoeiaSTERILE PURIFIED WATER
Sterile Purified Water is Purified Water, packaged and rendered sterile.
PharmacopoeiaSterile Monographed Waters
Sterile Monographed Waters The following monographed waters are packaged forms of either Purified Water or Water for Injection that have been sterilized
PharmacopoeiaVOLUMETRIC APPARATUS
Most of the volumetric apparatus available in the United States are calibrated at 20°, and the National Institute of Standards and Technology NIST has
GeneralEmulsions
An emulsion is a dispersed colloidal system consisting of two immiscible liquid phases generally stabilized with one or more suitable agents
Manufacturing and PackagingFilms PHARMACEUTICAL DOSAGE FORMS
USP-43 〈1151〉 Films PHARMACEUTICAL DOSAGE FORMS
PharmacopoeiaCapsules PHARMACEUTICAL DOSAGE FORMS
Capsules PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43, Chapter <1151>
GeneralPharmaceutical Dosage Forms: Complete Classification List
〈1151〉 PHARMACEUTICAL DOSAGE FORMS This article is based on the requirement of the United State Pharmacopoeia.
PharmacopoeiaParenteral 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…