You cannot simply replace bacteriostatic water with sterile water and vice versa, as they are not the same thing. This bacteriostat is usually 0.9% benzyl alcohol. 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. 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. It is also not known whether Bacteriostatic Water for Injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. While there is not a long-term shortage, an acute shortage is often seen because of either manufacturing facilities malfunction or some medical emergency such as COVID-19. Copyright 2023 by RxList Inc. An Internet Brands company. Lyophilization of Parenterals | FDA Always double-check which mixture you have because you cannot interchange between these two formulations. Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic preservative. That means, they are single-dose vials and should be discarded after a single-use. Please refer to the WARNINGS Good practice and a good quality assurance program would include the frequent monitoring of the volume of fill such as every 15 minutes. To answer this question, let's look at an example of Dr. Smith, a pharmaceutical scientist who needs to prepare a peptide solution for a clinical trial. The very first step is pick the syringe size that you have purchased. Minors or people below 18 years old are not allowed to use this Website. When preparing bacteriostatic water for injection, all product indications should be closely followed, including recommended dosages and injection schedules [4]. What you should be doing is drip the water onto the inner surface of the vial so that there is enough time for the lyophilized peptide and water to mix. event these should occur, re-evaluate the patient and institute appropriate You may report side effects to FDA at 1-800-FDA-1088. Administration of an estimated 9 mL to a 6 kg infant or neonate is potentially capable of producing blood pressure changes. Two independent temperature sensing systems. Storing the peptide in solution form is also a bit risky because they are more prone to degradation. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Bacteriostatic water formulations for injection have pH levels of 4.5-7, averaging 5.7. Okay, so this is some maths stuff that I need to explain to you before it really gets on your nerves. If you are already registered, please log in. There are no adverse or bad side effects of using sterile water in small doses, one should never take it intravenously. Do not use unless the solution is clear and seal intact. The re-use of sterile water for injections is strictly prohibited. Injection of HGH is considered safe when prescribed by a doctor. Bacteriostatic water differs from sterile water by the addition of benzyl alcohol as a preservative with a final concentration of 0.9%. Create your account and enjoy a new shopping experience. Water for Injection, USP is chemically designated H2O. Consult with pharmacist, if available. Bacteriostatic water and sterile water are essentially used for the same function which is to dissolve the drugs/medications for injecting purposes. Bacteriostatic water and sterile water can be used in intravenous, intramuscular and subcutaneous injections. Bacteriostatic Water for Injection, USP is supplied in a multiple-dose 30 mL plastic fliptop vial (List No. Lets take a look at each one, where they differ, and where they overlap. If you feel that any of our content is inaccurate or out-of-date, please contact us at: [emailprotected]. This can come into play when preparing for traveling, budgeting monthly expenses and storage. Plus, peptide solutions made with bacteriostatic water resist contamination. Bacteriostatic Water for Injections | The A-Z Guide Though their features overlap, bacteriostatic water and sterile water have several significant differences. For safe storage, adhere to manufacturer indications. 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. Our content is continually monitored by an internal peer-review process to ensure accuracy. Bacteriostatic water (BW) has a pH of about 5.7. Yes, distilled water can also be used to reconstitute peptides alongside the bacteriostatic and sterile water. Besides neonates, they both can be used for the rest of the population including pediatrics, adults and the geriatric community. As I mentioned at the start, the sterile water vial doesnt contain benzyl alcohol which makes it unfavorable for storage. 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. Read the full review on BPC 157 only at Muscle and Brawn. There may be cases in which sterile water is more appropriate, as outlined above. Is Bacteriostatic Water The Same As Sterile Water? This discussion will address some of the problems associated with the manufacture and control of a lyophilized dosage form. It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection. If available, sonication may be performed in order to speed up the process. 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). Intravenous administration of Bacteriostatic Water (bacteriostatic water (bacteriostatic water for injection) for injection) for Injection without a solute may result in hemolysis. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Lysis is the breaking down of a cell or membrane. The process of reconstitution is the same regardless of what kind of water you chose to reconstitute your AOD with. The process is simple. 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. 5.0 out of 5 stars Good product. We do the complete research and follow standards before starting the manufacturing process. Nothing really. Please enter the email address for your account. Medically reviewed by Drugs.com. Provisions for sterilizing and assuring the integrity of vent filters or filters used to sterilize the inert gas and air. Bacteriostatic water works well as a peptide solvent, reconstituting the compounds without compromising their effectiveness. 2. : regeneration of an organic form by reorganization of existent tissue without blastema formation. Bacteriostatic Water vs. Sterile Water | Deus Medical Correctly reconstituting peptides is essential in their effectiveness. ZOMACTON 10 mg reconstituted with bacteriostatic water for injection containing 0.33% metacresol should not be used if the patient is allergic to metacresol. It is always advisable to carefully read them before trying to reconstitute the peptides. 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. Using either in the proper conditions can provide extraordinary results. Some of the older lyophilizers cannot tolerate steam under pressure and sterilization is marginal at best. Its preservative content keeps it sterile to prevent infection, and its chemical properties allow it to efficiently dissolve solutes without compromising their integrity. Curious about Bacteriostatic Water for injections? Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. Bacteriostatic Water for Injection, USP containing additives should be given to a pregnant woman only if clearly needed. Besides, to avoid the degradation of peptides from moisture, allow the reconstituted peptide vial to come at room temperature after pulling it out from the refrigerator. Some peptides are still off-limits to us mere mortals, and only available for research purposes. Somatropin should not be used for. Be sure to consult indications for exact dosage and concentration. Bacteriostatic water (BW) has a pH of about 5.7. This solution has no antimicrobial agents. Use aseptic technique for single or multiple entry and withdrawal from all containers. To make it easy for you to get the best materials, the Peptides.org team has perused the web and selected the single best online source for your injection material requirements: This trusted vendor has an impressive selection of full research kits for your convenience. 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. The next step is to do is add the mass of the peptide in mg that you want to reconstitute (This is generally going to be listed on the peptide vial) with the x ml of bacteriostatic water in order to get your desirable dosage in mcg. Based on 31 documents. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Leucovorin Calcium - GlobalRPH No more confusion or frustration, just pure peptide power! If you are interested in using bacteriostatic water for injections, look no further! Because it is vulnerable to contamination, it is sold in single-dose containers [5]. For more information, please see our False Bacteriostatic Water is available generically and has the same name. If any provision of these Terms is found to be invalid under any applicable law, such provisions shall be deleted without affecting the remaining provisions herein. You can email the site owner to let them know you were blocked. PDF SOLU-MEDROL (methylprednisolone sodium succinate for injection, USP The Made with the organic preservative benzyl alcohol, this solution resists contamination to enable multiple doses per vial. The next and immediate step is to add the water you have drawn out into the peptide vial slowly yet smoothly. Intravenous administration of Bacteriostatic Water for Injection without a solute may result in hemolysis. The starter set has all you need to get going, including the following: If you want a little more, check out the premium kit: Qualified handlers are sure to enjoy this top online source for research materials. Before really using the peptide, you will have to add liquid to the powder and MIX it well to make it a solution but it isnt as simple as it sounds! 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. Sterile water is formulated for irrigation, such as rinsing wounds, unlike bacteriostatic water. Because there is 1ml of bacteriostatic water, this means that we need to mix 5000mcg with 1ml of bacteriostatic water. Provisions for sterilizing the inert gas or air supply lines. Only if the peptides are of the same nature such as growth hormone (GH) influencers or if you see any vendors selling a stack of particular peptides, only those you should mix. On the insulin syringe, 100 units correspond to 1ml, so 10 units will correspond to 0.1ml of the bacteriostatic water. Bacteriostatic Sodium Chloride: Package Insert - Drugs.com Daptomycin RF has a longer in-use shelf period although times vary based on dosage form (vial, IV bag, or syringe) and diluent used. The pH is 5.7 (4.5 to 7.0). Although products may be labeled for reconstitution with Bacteriostatic Water for Injection, Sterile Water for Injection (WFI) should be used to reconstitute products. Sample 1 Sample 2 Sample 3. Benzyl alcohol, a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in neonates. Some drugs can interact poorly with each solvent, and they are not considered universally interchangeable in clinical contexts. The following preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. Bacteriostatic Water (Bacteriostatic Water for Injection - RxList Due to the lack of antimicrobials, sterile water can easily be contaminated once exposed to surroundings and even yourself. Home > Peptides > Peptide Reconstitution + Mixing Guide with Calculator. Performance & security by Cloudflare. However, there are some differences between the two. Example would be 5g of CJC-1295 and 5g of ipamorelin. Bacteriostatic vs Sterile Water. It is only used for injections such as intravenous, intramuscular and subcutaneous. IMPORTANT Use only the accompanying diluent or Bacteriostatic Water For Injection with. corrective measures. Sterile water is water that has no additives or preservatives added to it. No information provided. Click to reveal This method can preserve the peptides stability and activity for several months to years, depending on the peptides properties and storage conditions. When in liquefied form, the somatropin substancesare very delicate. 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. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in very small infants. Bacteriostatic Water (bacteriostatic water for injection) is a highly purified, sterilized water containing 0.9% benzyl alcohol that is used to dilute or dissolve medications to the appropriate consistency for injection. Additionally, this stability testing should include least concentrated as well as the most concentrated reconstituted solutions. To the extent that Peptides.org references a product that is also a prescription medication, Peptides.org does not does not offer medical diagnosis or treatment advice. Reconstitution instructions: Reconstitute with 15.6 mL of bacteriostatic water for a total volume of 16 mL. Haven't had any problems with this bacteriostatic water. As defined in Section 10.01. The action you just performed triggered the security solution. Water balance is maintained by various regulatory mechanisms. This parenteral preparation is unlikely to Because many of the types of products are antibiotics, subpotency in a vial can present a potentially very serious situation. Your best option for assembling the necessary tool kit is a single, reputable source. [See USP Controlled Room Temperature. Bacteriostatic water is a sterile form of water that has been brought to a pH between 4.5 to 7.0. Buckle LLC, including its officers, directors and employees shall not be held liable for any indirect, consequential or special liability arising out of or in any way related to your use of this Website. However, if you can get your hands on some, then congratulations, youre already ahead of the game! Obviously, a low fill would represent a subpotency in the vial. All you have to do is add the desirable reconstituted peptides in 1 vial and then use the syringe to pull out the mixture so that you can administer it. 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. A generally recognized acceptable method of sterilizing the lyophilizer is through the use of moist steam under pressure. Parenteral preparations containing benzyl alcohol should not be used in epidural or spinal anesthesia procedures. Slowly extract the bacteriostatic water until the solution reaches your desired level. The safety and effectiveness of Bacteriostatic Water (bacteriostatic water (bacteriostatic water for injection) for injection) for Injection, USP have not been established in pediatric patients. Additionally, bacteriostatic water must always be mixed with a solute before injection. 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. The sterilization of the lyophilizer is one of the most frequently encountered problems. See PRECAUTIONS. .063 mg/mL, 3200 mL c. 1000 mg/mL, 5 mL d. 64 mg/mL b. You will soon see that your peptide powder will be dissolved and the vial will be transparent. Reviewed in the United States on January 28, 2023. Acidic peptides will be best soluble in basic solution and vice versa. Daptomycin: a comparison of two intravenous formulations Dont waste time and energy attempting to source syringes, alcohol swabs, and bacteriostatic water from multiple retailers. Bacteriostatic waters preservative content prevents contamination for multiple doses, while sterile water may be contaminated after one use. PDF SOLU-MEDROL (methylprednisolone sodium succinate) Label - Food and Drug Bacteriostatic water has a 0.9% benzyl alcohol content and an average pH level of 5.7, while sterile water is free of additives with a pH level of 5.0-7.0. Also, nothing contained on this Website shall be interpreted as advising you. 1996-2023 RxList, Inc. An Internet Brands company. swelling of your face, lips, tongue, or throat, redness, warmth, and pain at the injection site, tenderness or irritation at the injection site. In case any of the mentioned side effects are present, it is highly advisable to discontinue the use of bacteriostatic water and consult a doctor. My recommendation is to use bacteriostatic water as that's what most peptide vendors sell. IMPORTANT - Use only Bacteriostatic Water for Injection with Benzyl Alcohol . All you have to do is just follow the easy steps and BOOM! Statements regarding products presented on Peptides.org are the opinions of the individuals making them and are not necessarily the same as those of Peptides.org. 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. Parenteral preparations with benzyl alcohol should not be used for fluid replacement. Reconstitution follows the above method. Side Effects of Bacteriostatic Water (Bacteriostatic Water for - RxList Both act as dilutants or solvents of substances to enable injection. If the peptide still doesnt get dissolved, perform trial and error and use various other solvents. It would seem very difficult for a manufacturer to be able to demonstrate satisfactory validation of sterilization of a lyophilizer by chemical "treatment.". Using the 28-29 gauge insulin syringe, you will have to draw 0.1 ml of water per injection. Because of the potential toxicities associated with Bacteriostatic Water for Injection, many hospitals only utilize WFI. AOD 9604 can either be reconstituted in bacteriostatic water (BAC) or sterile water. Bacteriostatic Water may cause serious side effects including: Get medical help right away, if you have any of the symptoms listed above. Peptide Dosing Guide. Both have similar uses and are sterile but have drastically different demographics and indications. Due to the bacteriostat, bacteriostatic water comes in a multi-dose formulation for multiple uses. Report. Both have the dangerous side effect of hemolysis when injected alone. Peptides the proteins little brother can do wonders for our bodies! Research peptides present great potential in emerging clinical contexts, such as combating symptoms of cardiovascular and metabolic diseases, as well as improving reproductive health [11]. Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic preservative. It also is prepared with a bacteriostat, a compound used to prevent any bacterial growth. However, research is not considered conclusive. Allow the powder to naturally dissolve until the vial is transparent. Bacteriostatic Water belongs to a class of drugs called Sterile Irrigating Solutions. Data are unavailable on the toxicity of other preservatives in this age group. There have been times when sterile water has been in short supply. On the other hand, distilled water is rather more sterilized and contains neither organic nor organic materials. Buckle LLC is permitted to revise these Terms at any time as it sees fit, and by using this Website you are expected to review these Terms on a regular basis. The universal rule is to use 1 milliliter of bacteriostatic water for every peptide that you reconstitute. Helpful. Bacteriostatic Water for Injection, USP must be made approximately isotonic prior to use. Shortage of sterile water and reconstitution of omalizumab Available for Android and iOS devices. Use only as a diluent or solvent. How many mL are required for one dose? 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. Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride in water for injection. Using Bacteriostatic Water vs. Sterile Water - Paradigm Peptides 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. Both bacteriostatic water and sterile water are not used for straight injections, they have to be diluted with a drug or solvent. Peptide reconstitution is a complicated and confusing process for many. Reconstitution Definition: 569 Samples | Law Insider In the Bacteriostatic Water (bacteriostatic water for injection) is a highly purified, sterilized water containing 0.9% benzyl alcohol that is used to dilute or dissolve medications to the appropriate consistency for injection. Certain areas of this Website are restricted from being access by you and Buckle LLC may further restrict access by you to any areas of this Website, at any time, in absolute discretion. Remington's Pharmaceutical Sciences, 17th Edition, Mack Publishing Co., Easton, PA, 1985. Parenteral drug products should be inspected visually for particulate matter Plus, peptide solutions made with bacteriostatic water resist contamination. First, you want to thoroughly wash your hands with soap and water for at least 20 seconds. Bacteriostatic 0.9% Sodium Chloride (NaCl) Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride in water for injection. As discussed earlier, peptide mixing water is used to dissolve/dilute the lyophilized peptides. 1) Determine the quantity of peptide, in micrograms (mcg), in your vial. See PRECAUTIONS. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8 and the tonicities are, for the 40 mg per mL . You may be surprised to learn that they are not interchangeable [5]. These are the primary similarities between bacteriostatic water and sterile water [5]: Here are the key differences between bacteriostatic water and sterile water [5]: Despite their similarities, bacteriostatic water and sterile water differ in a few key areas. Bacteriostatic water is a sterile form of water that has been brought to a pH between 4.5 to 7.0. The .gov means its official.Federal government websites often end in .gov or .mil. Overdose & Contraindications OVERDOSE Use only as a diluent or solvent. By rejecting non-essential cookies, Reddit may still use certain cookies to ensure the proper functionality of our platform. Validation of this handling should also include the use of filled vials of media. This should hopefully shed some light on an easily confusing topic on which water to use. Now we will explore some of the most exciting applications. Because they are antibiotics, low bioburden of these formulations would be expected at the time of batching. Use aseptic technique for single or multiple entry and withdrawal from all containers. Sterile water is purified water that has been distilled and brought to a pH between 5.0 to 7.0. Store at 20 to 25C (68 to 77F). It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection. Wipe down all materials with an alcohol swab. You are granted limited license only for purposes of viewing the material contained on this Website. Performance & security by Cloudflare. Bacteriostatic Water This is the method of peptide reconstitution with bacteriostatic water for injection [13]: Human growth hormone has a range of therapeutic applications, from enhanced physical composition and performance, to treatment of hormone deficiency in adolescents and children [14, 15]. 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. Bacteriostatic water has wider availability and is simpler to manufacture. How to Mix HCG (Human Gonadotropin) - Defy Medical However, you are not allowed to assign, transfer, or subcontract any of your rights and/or obligations under these Terms. Water balance is maintained by various regulatory mechanisms. and our After that, collect and prep your materials. Recommended dosage guidelines are usually based on either the clinical trials or the efficacy of the peptide. Bacteriostatic Water for Injection Prescribing Information. The stopper is placed on top of the vial and is ultimately seated in the lyophilizer. This monograph has been modified to include the generic and brand name in many instances. Peptide Reconstitution + Mixing Guide With Calculator - Muscle and Brawn Penetrate the peptide vial as gently as you can. The filling of vials that are to be lyophilized has some problems that are somewhat unique. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. However, they do differ in their composition as the bacteriostatic water contains 0.9% benzyl alcohol as a preservative. Please let me know if you get an answer. During peptide reconstitution, two variations of solutions are popular. Gather the following: alcohol swabs, bacteriostatic water, peptide powder, and a sterile syringe. This is one of the reasons that vials of sterile water usually contain a few milliliters of the liquid. I need to rehydrate some BPC, but when I look for bacteriostatic water on Amazon, it takes me directly to "reconstitution solution."
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