This nomenclature has been adopted by the usp drug nomenclature committee forfree fatty acidsthe free fatty acids in 10g of oil require for implementation by supplemental revisions of usp 23nf 18. A nonsterile version may be used in manufacturing with. There is a concern that rouge particles could build up on a surface and release a. Water for injection generally is used as the vehicle, unless otherwise specified in the individual monograph. Note purified water is intended for use as an ingredient of official preparations and in tests and assays unless otherwise specified see water in ingredients and processes and in tests and assays under general notices and requirements. Water for injection is water purified by distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and. It contains no antimicrobial agent or other added substance. Sterile water for injection usp is a diluent suitable for intravascular injection after first having been made. Sterile water for injection is prepared from water for injection usp reference standards. Water for injection, usp is chemically designated h 2 o. Sterile water for injection, usp is a sterile, nonpyrogenic preparation of water for injec.
Usp water monographs descriptions of methods of preparation and uses bulk monographed waters and steam purified water pw quality is minimum where water referenced in usp water for injection water for hemodialysis pure steam sterile monographed waters possible quality issues based on container leachables sterile purified water. Stage 1 of the procedure below may alternatively be performed with the appropriate modifications to step 1 using online instrumentation that has been appropriately calibrated, whose cell constants have been accurately determined, and whose temperature compensation function has. Dextrose, usp is chemically designated dglucose, monohydrate c6h12o6 h2o, a hexose sugar freely soluble in water. Application number or monograph citation marketing start date marketing end. On april 1, 2012, the united states pharmacopeia usp published the removal of the legacy oxidizable substance test for the water monographs, sterile water for injection wfi, sterile purified water pw, sterile water for inhalation, and sterile water for irrigation. Do not use for intravenous injection unless adjusted to approximate isotonicity with a suitable solute. Specification for water for injection wfi as per usp. There are also other types of water for which there are noused in manufacturing, clinical, or analytical applications monographs.
Where used for sterile dosage forms, other than for parenteral administration, process the article to meet the requirements under sterility tests 71, or. Sterile water for injection, usp is a hemolytic agent due to its hypotonicity. Before such use other substances generally must be added to make the solution more or less isotonic. Design of purified water and water for injection systems. Sodium chloride may be added in amounts sufficient to render the resulting solution isotonic. Signup for the free email updates for your daily dose of pharmaceutical tips.
Sterile water for irrigation, usp is a sterile, nonpyrogenic solution and contains no bacteriostatic or antimicrobial agents or other substance. Mannitol injection, usp, 25%, an osmotic diuretic, is a sterile, nonpyrogenic solution of mannitol in water for injection. A sterile version is used for making solutions that will be given by injection. Haloperidol injection, usp is available as a sterile parenteral form for intramuscular injection. Ppt pdf pharmaceutical water system design validation. Sterile water for injection is prepared from water for injection that is sterilized and suitably packaged. It comments that any dosage form must be manufactured from purified water. The pharmacy bulk package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program.
Water for diluting concentrated haemodialysis solutions ph. It can be given by injection into a vein, muscle, or under the skin. Package insert mannitol injection, usp, 25% description. Water for injection wfi uspjp permits distillation or a purification process that is equivalent or superior to. Infed iron dextran injection usp is a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. Sterile water for injection, usp bound tree medical. Each ml contains the equivalent of 50 mg of elemental iron as an iron dextran complex, approximately 0. Sterile water for injection, usp is water for injection sterilized and packaged in. Know the specification of water for injection wfi as per united states pharmacopoeia. Antimicrobial agentsit meets the requirements under. Dextrose injection, usp is a parenteral fluid and nutrient replenisher. New united states pharmacopeia usp sterile water testing. Sterile water for injection, usp is a sterile, nonpyrogenic water for injection intended only for dilution purposes.
Capable of producing in excess of 20,000 liters per day, rmbio offers a highly competitive core portfolio of usp water and usp saline for manufacturing and processing applications. Attributes conflict free, gmo free, natural products, pharma grade, sterile, uspacs. Sterile water for injection is a pharmaceutic aid vehicle and parenteral fluid replenisher after addition of an appropriate solute. Water for injection is water of extra high quality without significant contamination. Usp sterile purified water wfi quality ricca chemical. Many of these waters are usedwater for injectionwater for injection see the usp. The safety of the plastic has been confirmed by tests in animals according to usp. Rouge particles are typically 1 6m in diameter, but theoretically could clump. Classical culture approaches for microbial testing of water include but are not limited to pour plates, spread plates, membrane filtration, and most probable number mpn tests. Water for injection, usp sterile grade 500ml 20l 1l 100l. The procedure described below is designed for measuring the conductivity of purified water and water for injection.
Each ml contains 5 mg haloperidol as the lactate with 1. It is a supersaturated solution at room temperature. Offline ankur choudhary is indias first professional pharmaceutical blogger, author and founder of pharmaceutical guidelines, a widelyread pharmaceutical blog since 2008. Therefore, it is contraindicated for intravenous administration without additives. Tested to usp monograph for sterile water for injection wfi, usp. It contains no antimiusp endotoxin rs crobial agent or other added substance.
Where used for the preparation of parenteral solutions subject to final sterilization, use suitable means to minimize microbial growth, or first render the water for injection sterile and, thereafter, protect it. The semirigid vial is fabricated from a specially formulated polyolefin. Sterile water for injection usp is a clear, colorless, odorless liquid. Water for injection fda prescribing information, side. In accordance with usps rules and procedures of the council of experts rules and except as provided in section 7. Sterile water for injection, usp is a sterile, nonpyrogenic, solutefree preparation of distilled water for injection. It is intended to be used as a diluent in the preparation of parenteral products, most typically for multidose products that require repeated. It is sterile, hypotonic, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents.
It is supplied in a multipledose container from which repeated withdrawals may be made to dilute or. Sterile water for injection contains no bacteriostat, antimicrobial agent or. Sterile water for injection, usp in viaflex plastic container baxter. At the heart of the operation is a cutting edge, 9 step, waterforinjection wfi purification system. It is a diluent or solvent suitable for intravascular injection after first having been made approximately isotonic by the addition of suitable solute. These are all bulk waters, with names given where the pure bulk form of the water is indicated. Oxidizable substances to 100 ml add 10 ml of 2 n sulfuric acid, and heat to boiling. For sterile water for injection in containers having a fill volume of less than 50 ml, add 0. Classical culture approach for microbial testing of water. Noteuse bacteriostatic water for injection with toxin unitml due regard. Magnesium sulfate injection, usp 50% is a sterile, nonpyrogenic, concentrated solution of. It is for use only as a sterile solvent or diluent vehicle for drugs or solutions suitable for parenteral administration.
Bioprocess solutions, buffers, high purity water, process solvents, solvents. Sterile water for injection usp 2l and 3l in flexible containers and. Nf more than 4500 monographs the uspnf is the official authority fdaenforceable standards. Usp bacteriostatic water for injection usp sterile water for irrigation the usp designation means that the water is the subject of an official monograph in the current us pharmacopeia with various. Water for injection is the key component for iv fluids manufacturing. The flexible container is fabricated from a specially formulated nonplasticized, film. Sterile water for injection, usp, is a sterile, nonpyrogenic, distilled water in a pharmacy bulk package. Hemolysis may occur following infusion of sterile water for injection. Water for injection, usp sterile grade 500ml 20l 1l 100l 10l 200l. United states pharmacopoeia 788, particulate matter in injections states maximum particle size 25 6m. Bacteriostatic water for injection, usp is a sterile, nonpyrogenic preparation of water for injection containing 0.
Do not inject until made approximately isotonic by addition of appropriate solute. Bacteriostatic water for injection bacteriostatic water for injection see usp monograph is sterile water for injection to which has been added one or more suitable antimicrobial preservatives. Usp standards for packaged purified water, water for injection and sterile purified water usp24 effective 1100 the following are numerical value limits that are commonly used interpretations of the procedures listed on pages 1752 and 1753 under the individual monographs. Epinephrine injection, usp materialsafetydatasheet date printed. Water for injection, usp is chemically designated h2o.
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