is reconstitution solution the same as bacteriostatic water?

Those are bacteriostatic and sterile water. If you notice that the powder does not properly dissolve, try a stronger solvent. Home > Peptides > Peptide Reconstitution + Mixing Guide with Calculator. Okay, we made up that statistic, but its probably close to the truth. In no event shall Buckle LLC, nor any of its officers, directors and employees, shall be held liable for anything arising out of or in any way connected with your use of this website whether such liability is under contract. Do NOT use sterile water for injection for flushing VADs. By accepting all cookies, you agree to our use of cookies to deliver and maintain our services and site, improve the quality of Reddit, personalize Reddit content and advertising, and measure the effectiveness of advertising. Composed of sterile water and 0.9% benzyl alcohol and an organic preservative agent, bacteriostatic water resists bacterial growth and contamination [1]. Before sharing sensitive information, make sure you're on a federal government site. Haven't had any problems with this bacteriostatic water. You can go as high as 2 milliliters per peptide reconstitution as it does no harm other than more dilution. This bacteriostat is usually 0.9% benzyl alcohol. All you have to do is just follow the easy steps and BOOM! The semi-rigid vial is fabricated from a specially formulated polyolefin. What is the difference between bacteriostatic water vs. sterile water for injection? The stopper is placed on top of the vial and is ultimately seated in the lyophilizer. There are several actions that could trigger this block including submitting a certain word or phrase, a SQL command or malformed data. There is no sort of preservative or antimicrobial agent added to it. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. Any user ID and password you may have for this Website are confidential and you must maintain confidentiality as well. Sterile water is formulated for irrigation, such as rinsing wounds, unlike bacteriostatic water. Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. Failure to do so risks the development of hemolysis, damaging the red blood cells [9, 10]. However, if you can get your hands on some, then congratulations, youre already ahead of the game! From medications to peptides and hormones, bacteriostatic water is a winning option when it comes to reconstitution and sterility. Pregnancy: Animal reproduction studies have not been conducted with Bacteriostatic Water for Injection. Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride in water for injection. Would love your thoughts, please comment. corrective measures. On the other hand, distilled water is rather more sterilized and contains neither organic nor organic materials. ITG SUBJECT: LYOPHILIZATION OF PARENTERALS. Because different stoppering equipment is required, stoppers are sometimes placed on vials by operators rather than by machine. All Right Reserved. When diluting or dissolving drugs, mix thoroughly and use promptly. Additionally, bacteriostatic water must always be mixed with a solute before injection. Additionally, this stability testing should include least concentrated as well as the most concentrated reconstituted solutions. Sterile water is free of any organic materials but contains inorganic materials to some extent. and ADVERSE REACTIONS. Pregnancy: Animal reproduction studies have not been conducted with Bacteriostatic Water for Injection. How does the math work when reconstituting a peptide with 5mg of two different peptides in the same vial? Warning:The content on Muscleandbrawn.com and the information included in this article is intended for entertainment and informational purposes only. ], Hospira, Inc., Lake Forest, IL 60045 USA. Example would be 5g of CJC-1295 and 5g of ipamorelin. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. Before really going straight into the topic, lets first understand the need for the phrase reconstituting peptides. To do the reconstitution of PT-141 you will need: Vial of PT-141 Vial of bacteriostatic water (or sterile water) Typical finished product testing that should be reviewed includes dose uniformity testing, sterility testing, and any required stability testing of aged batches of reconstituted solutions. However, they do differ in their composition as the bacteriostatic water contains 0.9% benzyl alcohol as a preservative. Because they are antibiotics, low bioburden of these formulations would be expected at the time of batching. Reddit and its partners use cookies and similar technologies to provide you with a better experience. Dont wait to enjoy the benefits of bacteriostatic water for injections. ; New York City, Nov. 13, 1968. No, you cant just inject bacteriostatic water alone! Sterile water usually comes in single-unit doses and the reuse of units is prohibited. Validation of these types of filling operations should include media fills and the sampling of critical surfaces and air during active filling (dynamic conditions). It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection. RxList does not provide medical advice, diagnosis or treatment. Sterile water is purified water that has been distilled and brought to a pH between 5.0 to 7.0. Bacteriostatic Water may cause serious side effects including: Get medical help right away, if you have any of the symptoms listed above. With the presence of 0.9% benzyl alcohol, the shelf-life of a bacteriostatic water vial is considerably increased up to 28 days as it will prevent the growth of any bacteria. Its like a chemistry experiment, but instead of blowing things up, youll be improving your health. May contain hydrochloric acid for pH adjustment. 94-101, 114; 1979. For intravenous or intramuscular injection, prepare solution by aseptically adding not more than 2 mL of Bacteriostatic Water for Injection or Bacteriostatic Sodium Chloride Injection to the contents of one vial. Another method of sterilization that has been practiced is the use of gaseous ethylene oxide. Your IP: It is a copolymer of ethylene and propylene. Consult with pharmacist, if available. Due to the pH, a more apt solution for fluid replacement is normal saline or dextrose. You hereby indemnify to the fullest extent Buckle LLC from and against any and/or all liabilities, costs, demands, causes of action, damages and expenses arising in any way related to your breach of any of the provisions of these Terms. Good practice and a good quality assurance program would include the frequent monitoring of the volume of fill such as every 15 minutes. Gather the following: alcohol swabs, bacteriostatic water, peptide powder, and a sterile syringe. If an adverse reaction does occur, discontinue the infusion, evaluate . 5.161.53.20 For example, the recommended dosage of BPC-157 is 1mcg to 10mcg per kg of body weight which accounts for 200mcg to 1000mcg per injection. You'll need an alcohol wipe, your bacteriostatic water and HCG vials, your reconstitution syringe and needle, and a Sharps container for safe disposal. By rejecting non-essential cookies, Reddit may still use certain cookies to ensure the proper functionality of our platform. During peptide reconstitution, two variations of solutions are popular. Bacteriostatic Water vs reconstitution solution whats the difference? Peptides.org makes no claims that any products referenced can cure, treat or prevent any conditions, including any conditions referenced on its website or in print materials. In order to provide guidance and information to investigators, some industry procedures and deficiencies associated with lyophilized products are identified in this ITG. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Note that sodium chloride water shouldnt be used as it may result in precipitates. It could be potentially harmful to try to reconstitute a peptide meant for mixing with bacteriostatic water with sterile water. Bacteriostatic water is very easy to manufacture while sterile water is an arduous process. Experts state that it may be necessary to run trials in order to select the best solvent for various peptides, and sodium chloride water should be avoided [12]. RedwolfWV Registered User Awards 1 May 24, 2008 #4 Ahh I get it. In case you have any issue diluting peptides in bacteriostatic water, you should add a small amount of 10% aqueous acetic acid for basic peptides and aqueous ammonia for acidic peptides. Generally lyophilized products have short expiration dates. Bacteriostatic Water (bacteriostatic water (bacteriostatic water for injection) for injection) for Injection, USP containing additives should be given to a pregnant woman only if clearly needed. Available for Android and iOS devices. This article will guide you step-by-step on how to mix your peptides well enough and will clear all your questions so that you can enjoy the maximum efficacy of peptides. Bacteriostatic Water may be used alone or with other medications. All rights reserved. Using either in the proper conditions can provide extraordinary results. Acidic peptides will be best soluble in basic solution and vice versa. However, there are some differences between the two. There are no adverse or bad side effects of using sterile water in small doses, one should never take it intravenously. Bacteriostatic waters preservative content prevents contamination for multiple doses, while sterile water may be contaminated after one use. After that, collect and prep your materials. pose a threat of fluid overload except possibly in very small infants. Freeze-drying: Freeze-drying, also known as lyophilization, is a method that removes water from the peptide solution and allows the peptide to be stored in a stable, dry form at room temperature for an extended period. Bacteriostatic water and sterile water are essentially used for the same function which is to dissolve the drugs/medications for injecting purposes. Buckle LLC reserves the right to remove any of Your Content from this Website at any time without notice. Generally, lyophilizers should be sterilized after each cycle because of the potential for contamination of the shelf support rods. Where water is required for preparing or diluting medications for use in neonates, only preservative-free Sterile Water for Injection should be used. Parenteral preparations with benzyl alcohol should not be used for fluid replacement. If symptoms appear, injections should be discontinued pending medical consultation [9]. If you are interested in using bacteriostatic water for injections, look no further! Unfortunately, piping such as that for the administration of inert gas (usually nitrogen) and sterile air for backfill or vacuum break are often inaccessible to such surface "sterilization" or treatment. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Carefully install the needle tip on a syringe. It is essential to avoid repeated freeze-thaw cycles and exposure to light and high temperatures. The small volume of fluid provided by Bacteriostatic Water for Injection, USP when used only as a pharmaceutic aid for diluting or dissolving drugs for parenteral injection, is unlikely to exert a significant effect on fluid balance except possibly in very small infants. Some of the older lyophilizers cannot tolerate steam under pressure and sterilization is marginal at best. You use AA, wich is a .6% solution of acetic acid. Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic preservative. But dont get too excited just yet. Store at 20 to 25C (68 to 77F). LTD.Salt Lake Electronics ComplexEP Block, Sector V, BidhannagarKolkata, West Bengal 700091, INDIA. Give half a minute for the alcohol to dry so that there is absolutely no risk of bacterial growth. Using the 28-29 gauge insulin syringe, you will have to draw 0.1 ml of water per injection. Dont waste time and energy attempting to source syringes, alcohol swabs, and bacteriostatic water from multiple retailers. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection. Then you're in luck! Parenteral preparations containing benzyl alcohol should not be used in epidural or spinal anesthesia procedures. Most peptides that you will see are often sold as lyophilized peptides which means that (freeze-dried) powder form. Based on 31 documents. Sterilization procedures should parallel that of an autoclave and a typical system should include: Provisions for sterilizing the shelf support rods unless they are only exposed to the inside of the chamber after stoppering. Short-term storage can be done at 4C, while long-term storage can be done by freezing at -20C or -80C, or by lyophilization. As I mentioned at the start, the sterile water vial doesnt contain benzyl alcohol which makes it unfavorable for storage. Dosage form: injection, solution It would ideally be either 0.3ml, 0.5ml or 1ml syringe. Both are suitable for subcutaneous intravenous, intramuscular, and intradermal injections. ZOMACTON 10 mg reconstituted with bacteriostatic water for injection containing 0.33% metacresol should not be used if the patient is allergic to metacresol. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Due to the lack of antimicrobials, sterile water can easily be contaminated once exposed to surroundings and even yourself. We strive to never have a piece of inaccurate information on this website. This guide has you covered. The process is simple. Lets nail the major differences right from the start. Sterile water is water that has no additives or preservatives added to it. But dont worry, were here to help you navigate this tricky process. Obviously, there is a much greater chance of contamination in this type of operation because of the involvement of people. By using this Website, you agreed to accept all terms and conditions written in here. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. Sample 1 Sample 2 Sample 3. FDA rev date: 6/15/2000. Exogenous formulations are available in powder and liquid forms. This Website is provided as is, with all faults, and Buckle LLC express no representations or warranties, of any kind related to this Website or the materials contained on this Website. Flamberg, DW; "Manufacturing Considerations in the Lyophilization of Parenteral Products"; Pharmaceutical Manufacturing, Volume 3, No. A major difference between the two is the patient population. Overall, specialists agree that bacteriostatic water for injection is safer and more effective in most cases. Bacteriostatic water formulations for injection have pH levels of 4.5-7, averaging 5.7. Reconstituted peptides can be stored in several ways, depending on the duration of storage and the desired shelf life. Bacteriostatic Water for Injection, USP must be made approximately isotonic prior to use. Both act as dilutants or solvents of substances to enable injection. Obviously, a low fill would represent a subpotency in the vial. Privacy Policy. This method can preserve the peptides stability and activity for several months to years, depending on the peptides properties and storage conditions. In order to reconstitute 10 equal dosages, we need to mix 1ml of bacteriostatic water in all the 10 injections, which means 0.1ml of water per dosage. As with any ethylene oxide treatment, humidification is necessary. Our focus is to exclusively link to peer-reviewed studies found on respected websites, like PubMed. Although, a small percentage of people report inflammation at the injection site if sterile water is used to dilute peptides that are to be injected intramuscularly. Bacteriostatic water is usually the term given to a commercial preparation (made by Hospira, for example), whereas reconstitution solution is the term given by a smaller (usually underground) company that makes its own to sell. This monograph has been modified to include the generic and brand name in many instances. Storing peptides is a very crucial step because a slight fluctuation in the physical conditions can really degrade the peptide vial. Bacteriostatic Water (bacteriostatic water (bacteriostatic water for injection) for injection) for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. Helpful. Reconstitution means a process that may be used to initiate a range of accountability actions to . This information, including any referenced scientific or clinical research, is made available for educational purposes only. We partner major pharmaceutical companies in India & abroad as a reliable and efficient contract manufacturer. So it all differs and the exact dosage can only be prescribed by your health practitioner. Once the peptide is really made soluble in any of the relevant solutions, diluting it with bacteriostatic water or sterile water is recommended. Made with the organic preservative benzyl alcohol, this solution resists contamination to enable multiple doses per vial. Recent inspections have disclosed potency and sterility problems associated with the manufacture and control of lyophilized products. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. Lets explore their points of similarity and difference to understand their appropriate uses. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. In these Website Standard Terms and Conditions, Your Content shall mean any audio, video text, images or other material you choose to display on this Website. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. The pH is 5.7 (4.5 to 7.0). As the recommended dosage is 500mcg, dividing the total of 5000mcg by 500mcg will yield 10 injections per BPC 157 vial. Cookie Notice It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection. Additionally, stability data should include provisions for the assay of aged samples and subsequent reconstitution of these aged samples for the maximum amount of time specified in the labeling. I'm diluting my AA (vinegar) to get to 0.6% AA. They can manage our circadian rhythms, regulate growth hormones, help with weight loss, and even make us look younger. Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, . See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination. 4 people found this helpful. Because there is 1ml of bacteriostatic water, this means that we need to mix 5000mcg with 1ml of bacteriostatic water. Last reviewed on RxList: 10/13/2021 Peptide reconstitution is a complicated and confusing process for many. Water balance is maintained by various regulatory mechanisms. Note that you should absolutely not stir or shake the vial as it is going to damage the peptide and it will no longer be effective. Mrose . if a dosage is say 20mcg of each individually, wht is a dosage of the mix? If available, sonication may be performed in order to speed up the process. The second step is to use your syringe and draw out 1ml of bacteriostatic water from the vial without really touching the needle as it could cause contamination. .063 mg/mL, 3200 mL c. 1000 mg/mL, 5 mL d. 64 mg/mL b. Deshalb, im Laufe der Jahre konnten wir einen Ruf als einer der besten unabhngigen Beratern zu bauen. a. (Isotonic saline = 0.28 osmolar.) Bacteriostatic water is water with benzyl alcohol. See PRECAUTIONS. Bacteriostatic Water for Injection may kill some of the vegetative cells if present as contaminants. Using in such a matter can cause hemolysis or destruction of red blood cells. In case you experience any of these side effects, you should immediately stop using sterile water for injections and talk to a doctor. A major concern with the filling operation is assurance of fill volumes. 3, pp. See WARNINGS, PRECAUTIONS Reconstitution Solution versus Bacteriostatic Water I need to rehydrate some BPC, but when I look for bacteriostatic water on Amazon, it takes me directly to "reconstitution solution." If both items are the same (benzyl alcohol bacteriostatic solutions) why use the different name? and PRECAUTIONS sections. The .gov means its official.Federal government websites often end in .gov or .mil. Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. Also, nothing contained on this Website shall be interpreted as advising you. Click to reveal Is Bacteriostatic Water The Same As Sterile Water? With our easy-to-use reconstitution calculator, you now dont have to worry about all the multiplication, division or the unit conversion and all. It is recognized that there is complex technology associated with the manufacture and control of a lyophilized pharmaceutical dosage form. [See USP Controlled Room Temperature. (I would personally recommend bacteriostatic water because of its longer shelf-life). Due to the potential for toxicity, solutions containing benzyl alcohol should not be used in neonates. Most peptide packages contain mixing instruction. It would seem very difficult for a manufacturer to be able to demonstrate satisfactory validation of sterilization of a lyophilizer by chemical "treatment.".
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