Bacteriostatic water for injection

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

Enbrel Enbrel is used for the treatment of rheumatoid arthritis. It is supplied as a sterile, preservative-free, lyophilized powder. The powder is reconstituted with 1 mL sterile bacteriostatic water-for-injection (containing 0.9% benzyl alcohol) prior to parenteral injection. 

IM administration Reconstitute cefepime with the following diluents Sterile Water for Injection, 0.9% Sodium Chloride, 5% Dextrose Injection, 0.5% or 1 % lidocaine hydrochloride, or Sterile Bacteriostatic Water for Injection with parabens or benzyl alcohol. 

Dosage form Leukine is formulated as a sterile, preserved, injectable solution (500pg/l) in a 1ml vial. Lyophilized Leukine is a sterile, preservative-free powder (250 pg) that requires reconstitution with sterile water for injection or bacteriostatic water for injection. 

Dosage form Protropin is supplied as a sterile, lyophilized powder for reconstitution with bacteriostatic water for injection. Each vial contains somatrem 5 mg or 10 mg. 

Bacteriostatic water for injection USP Distillation or reverse osmosis Yes Multiple and single dose... 

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. 

Bacteriostatic water for injection carbon dioxide-free water ... 

Comments the USP 28 (Suppl. 1.0) describes bacteriostatic water for injection as sterile water for injection that contains one or more suitable antimicrobial agents. 

Benzyl alcohol is a preservative that may be present in multidose vials of bacteriostatic sodium chloride and bacteriostatic water for injection and pharmaceuticals available in multidose vials for parenteral use. An association between the presence of benzyl alcohol in solutions used for flushing intravascular catheters and to reconstitute medications and a gasping syndrome and deaths in neonates was first reported in the early 1980s.The neonates also displayed clinical findings such as an elevated anion gap, metabolic acidosis, CNS depression, seizures, respiratory failure, renal and hepatic failures, cardiovascular collapse, and death. Those at highest risk were premature infants who weighted less... 

Among single drug component studies, usual vehicles for dilution are 5% dextrose (D5W), 0.9% sodium chloride (normal saline, NS), aqueous buffers, peritoneal dialysis fluid, nonaqueous solvents, water for injection, phosphate-buffered saline, bacteriostatic water for injection, bacteriostatic sodium chloride. Ringer s injection, and lactated Ringer s. Stability studies can also be carried out on the drug product solution as such or in specific containers or injection devices. Solutions and suspensions can also be prepared extemporaneously and stability tested to show worthiness for oral, ophthalmic, or rectal administration. The following is an example of the first... 

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. 

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. 

Elerceptin Lyophile for IV injection, reconstitute with bacteriostatic water 2-8°C as lyophile up to expiration date reconstituted solution stable 28 days at 2-8°C 440 mg vial 9.9 mg L-histidine HCL, 6.6 mg L-histidine, 400 mg trehalose, 1.8 mg polysorbate 20... 

Etanercept is available as a preservative-free powder for reconstitution or as a solution in prefilled syringes. The powder should be reconstituted in bacteriostatic water, containing 0.9% benzyl alcohol, to a final concentration of etanercept of 25 mg/mL. The prefilled syringes contain 25 mg or 50 mg etanercept in a 1% sucrose solution containing sodium phosphate, sodium chloride and l-arginine. Both preparations are administered by subcutaneous injection. 

Transfer a volume of injection solution to the column so that the amount of active ingredient when eluted with a minimum volume of 25 ml of N sulphuric acid can be determined spectrophotometrically. Wash the column with at least 50 ml of water (two 25-ml portions) under pressure and dilute the eluate containing the bacteriostatic agent to a suitable volume so as to permit its determination by measuring the maximum extinction at about 269 mfJL for phenol or 279 m/ for chlorocresol. When 0 5 per cent of phenol is used as the bacteriostatic agent, it is necessary to dilute the initial aliquot 100 to 200 times to obtain a suitable concentration in the eluate when 0 3 per cent of chlorocresol is used the dilution is 50 to 100 times. 

Most studies on the direct introduction of water involve the on-line coupling of micro-LC and GC because the LC peak volumes and, consequently, the amount of water-containing eluent that has to be transferred, will then be small. For exam pie, Cortes et al. [7], who used an on-column interface and a nondeactivated retention gap, introduced up to 20 p.1 of acetonitrile water (50 50, v/v) and even pure water without serious distortion of the peaks of components eluting near the fully concurrent solvent evaporation (see Chap. 1) transfer temperature. One application dealt with the determination of the toxic bacteriostat, N-Serve, in corn. In another study, chlorpyrifos was determined in well water after a direct large-volume (20 Ltl) injection into the GC system [8]. However, the risk remains that more polar analytes will be adsorbed on the inner wall of the nondeactivated retention gap, which will result in bad peak shapes. 

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