Water for Injection USP

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. 

Depyrogenation methods used by compounding pharmaeists inelude dry heat and rinsing with Sterile Water for Injection, USP. 

Sterile water for injection, USP (Abbott Laboratories, North Chicago, IL). Polypropylene, 50-mL sterile, conical centrifuge tubes (Becton Dickinson Labware, Lincoln Park, NJ). 

Sterile water for injection, USP (Abbott Laboratories, North Chicago, IL). 

It is important to understand the various types of waters used in parenteral products. The most frequently used solvent in parenteral products is Water for Injection, USP, which is not required to be sterile... 

Water for injection USP (WFI) Distillation or reverse osmosis Yes Not sterile. Must be used within 24 h orstored below 5°C or >80°C used for manuf. of parenteral products tobe sterilized... 

Sterile water for injection USP Distillation or reverse osmosis Yes Same as WFI single-dose containers also used to reconstitute sterile solids and dilute sterile solutions... 

SVIs are available as sterile dry solids that must be reconstituted with a diluent, usually sterile water for injection, USP, before being administered as a solution or suspension. Sterile dry SVIs are prepared using two primary methods. 

The most widely used solvent for SVIs is water for injection (WFI), USP. As a solvent, WFI is used in preparing the bulk solution (compounding) and as a final rinse for equipment and packaging preparation. WFI is prepared by distillation or reverse osmosis, although only distillation is permitted for sterile water for injection, USP. Sterile water for injection is used as a vehicle for reconstitution of sterile solid products... 

Bacteriostatic Water for injection (USP), used to dilute or reconstitute medications for intravenous use. The content of benzyl alcohol in a lot of injectable pharmaceutical formulations needs to be considered carefully. The view still taken in many countries that the additives and excipients in medicines are trade secrets must be deplored. The duty to declare them is only realized in some countries. 

Dactlnomydn, USP. Cosinegen. actinomycin D. acti-nomycin C. actinomycin IV. NSC-3053, is obtained from the fermentation of selected strains of Sireplomyces parvu-Ills. It is soluble in alcohols and alcohol-water mixtures however, these solutions are very sensitive to light. Vials containing 0.5 mg of lyophilized powder of the drug and 20 mg of mannitol are supplied. For reconstitution. I.l mL of Sterile Water for Injection. USP is added to the vial. The re.sulting solution is stable for 2 to 5 months at room temperature. 

Each syringe deiivers 0.8 ml (40 mg) of DP. Each vial contains approximately 0.9 mL of solution to deiiver 0.8 ml (40 mg) of DP. Each 0.8 ml contains 40 mg of adaiimumab, 4.93 mg of sodium chioride, 0.69 mg of monobasic sodium phosphate dihydrate, 1.22 mg of dibasic sodium phosphate dihydrate, 0.24 mg of sodium citrate, 1.04 mg of citric acid monohydrate, 9.6 mg of mannitol, 0.8 mg of polysorbate 80 and water for injection, USP. Sodium hydroxide added as necessary to adjust pH. 

Each vial and prefilled syringe contains 0.03 mg/mL of interferon alphacon-1, 5.9 mg/mL of sodium chloride, and 3.8 mg/mL of sodium phosphate in water for injection, USP. 

Fluid Sterile water for injection USP Various manufacturers ... 

Sodium Chloride Injection USP is a sterile isotonic solution of sodium chloride in Water for Injection USP. It contains 154 mEq of sodium and chloride ions per each liter, and may be used as a sterile vehicle in preparing solutions or suspensions of drugs for parenteral administration. 

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