Injections water for

Sterile Filtration of Gases. Primary appHcations for sterile gas filtration are the sterilization of fermentor inlet air, fermentor vent gas, vents on water for injection tanks, and vacuum break filters during lyophilization. Operational and process considerations apply. Typically, the membrane in gas... 

The USP recognizes three forms of water for parenteral dosage forms. Water for injection is prepared by reverse osmosis or distillation, which... 

Sterile water for injection is used mosdy for the solution or suspension of dmgs just before injection. In containers of 30-mL capacity or less, it may contain a bacteriostatic agent. Inclusion of such agents in larger volumes can cause toxicity. 

Bacteriostatic water for injection is sterile and pyrogen-free and contains bacteriostatic agents. The dmg involved must be compatible with the antimicrobial agents present. 

Clinical Use. Vancomycin and teicoplanin as fomiulated dmgs are lyophilized powders to be reconstituted with sterile water for injection. Vancomycin hydrochloride [1404-93-9] is presented in vials of 500 mg that give 100—200 mL solution of pH 2.5—4.2. It is administered by slow (60 min) infusion at a dose of 500 mg every 6 h or 1 g every 12 h/d. The teicoplanin contains the five factors (87%) plus 13% of the pseudoaglycone T-A3-1. It is presented in vials containing 200 mg of lyophili ed power that after dissolution with 3 mL of solvent gives a solution at pH 7.5. The dose regimen is 200—800 mg/d by iv bolus adrninistration. 

Methicillin sodium To reconstitute 1 g vial add 1.5 mL of sterile water for injection or sodium chloride injection. Each reconstituted mL contains approximately 500 mg of methicillin. 

Water-for-Injection, which is used for parenteral injection products. 

Table 11.3 Specifications for United States Pharmacopoeia (USP) grade Purified Water and Water for Injection.

Most injections are formulated as aqueous solutions, with Water for Injections BP as the vehicle. The formulation of injections depends upon several factors, namely the aqueous solubility of the active ingredient, the dose to be employed, thermal stability of the solution, the route of injection and whether the product is to be prepared as a multidose one (i.e. with a dose or doses removed on different occasions) or in a singledose form (as the term suggests, only one dose is contained in the injection). Nowadays, most injections are prepared as single-dose forms and this is mandatory for certain routes, e.g. spinal injections such as the intrathecal route and large-volume intravenous infusions (section 2.2). Multidose injections may require the inclusion of a suitable... 

In cases of severe acute asthmatic attacks, bronchodilators and steroids for direct dehveiy to the lungs may be needed in large doses. This is achieved by direct inhalation via a nebulizer device this converts a liquid into a mist or fine spray. The dmg is diluted in small volumes of Water for Injections BP before loading into the reservoir of the machine. This vehicle must be sterile and preservative-fiee and is therefore prepared as a terminally sterilized unit dose in polyethylene nebules. 

Process water applications include boiler water feed pretreatment before ion exchange or electrodialysis. RO is also used for ultrahigh-purity water production for use in laboratories, medical devices (kidney dialysis), microelectronic manufacturing (rinse fluids per ASTM D-19 D5127-90, 1990), and pharmaceutical manufacturing (purified water or water for injection as specified by USP). 

The HIC column was equilibrated in ammonium acetate, pH 8.5 to 11.0, and elution was achieved by washing in a solution of lowered salt concentration. Preliminary experiments indicated that the salt concentration of the crude ammoniacal solutions had to be increased by addition of ammonium acetate to ensure binding of DMT-on product to the column. While elution with low concentrations of ammonium acetate was tried, the most successful procedures involved use of plain water (in this case, water for injection). Flow-through and wash fractions contain the DMT-off failure sequences. The water wash contains the DMT-on sequences. Table 2 contains a summary of some of the key experiments used to develop the final HIC protocol. 

Water for injection (WFI) is the most widely used solvent for parenteral preparations. The USP requirements for WFI and purified water have been recently updated to replace the traditional wet and colorimetric analytical methods with the more modern and cost-effective methods of conductivity and total organic carbon. Water for injection must be prepared and stored in a manner to ensure purity and freedom from pyrogens. The most common means of obtaining WFI is by the distillation of deionized water. This is the only method of preparation permitted by the European Pharmacopoeia (EP). In contrast, the USP and the Japanese Pharmacopeias also permit reverse osmosis to be used. The USP has also recently broadened its definition of source water to include not only the U.S. Environmental Protection Agency National Primary Drinking Water Standards, but also comparable regulations of the European Union or Japan. 

Process controls include daily testing of water for injection (USP), conformation of fill doses and yields, checking and approving intermediate production tickets, and checking label identity and count. Finished product control includes all the tests necessary to ensure the potency, purity, and identity of the product. Parenteral products require additional tests, which include those for sterility, pyrogens, clarity, and particulate analysis, and for glass-sealed ampoules, leaker testing. 

Several guidelines are available in the literature for the pharmacist who must extemporaneously prepare an ophthalmic solution. The USP contains a section on ophthalmic solutions, as do other compendia and several standard textbooks. Since the pharmacist does not have the facilities to test the product, he or she should dispense only small quantities, with an expiration date of no more than 30 days. Refrigeration of the product should also be required as a precautionary measure. To reduce the largest potential source of microbial contamination, only sterile purified water should be used in compounding ophthalmic solutions. Sterile water for injection, USP, from unopened IV bottles or vials is the highest-quality water available to the pharmacist. Prepackaged sterile water with bacteriostatic agents should not be used. 

Vehicles. Ophthalmic drops are, with few exceptions, aqueous fluids using purified water USP as the solvent. Water for injection is not required as it is in parenterals. Purified water meeting USP standards may... 

FDA approved intraocular injections include mio-tics, viscoelastics, and viscoadherents and an antiviral agent for intravitreal injection. The approved intraocular miotics, carbachol (Miostat ) and acetylcholine (Miochol ), are injected into the anterior chamber at the end of cataract surgery to constrict the pupil and allow the iris to cover the implanted intraocular lens. Carbachol is formulated in a BSS vehicle in sterile water for injection at a physiological pH... 

Miconazole injection is a sterile solution of miconazole in water for injection. It contains not less than 90% and not more than 110% of the labeled amount of... 

Neumega is the tradename given to the IL-ll-based product approved for the prevention of thrombocytopenia. The product is produced in engineered E. coli cells and is presented as a purified product in freeze-dried format. Excipients include phosphate buffer salts and glycine. It is reconstituted (with water for injections) to a concentration of 5 mg ml-1 before s.c. administration. 

Sterile water for injection and irrigation (excl pour bottles) in containers of 100 ml or more. 

Certain medications including penicillins and other antibiotics are unstable when stored in solution form and are therefore packaged in powder form. The dry powders must be reconstituted with a sterile diluent such as sterile water for injection or sterile sodium chloride (normal saline) solution. Instructions supplied with the vial state the volume of diluent which should be added. The resulting volume of the reconstituted drug and the approximate average concentration per milliliter are provided in the label or the package information sheet (package insert). 

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