Animal reproduction studies have not been conducted with Bacteriostatic Water (bacteriostatic water for injection) for Injection. It is only used for injections such as intravenous, intramuscular and subcutaneous. Please include what you were doing when this page came up and the Cloudflare Ray ID found at the bottom of this page. Bacteriostatic Water vs reconstitution solution whats the difference? Last reviewed on RxList: 10/13/2021 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. The filling of vials that are to be lyophilized has some problems that are somewhat unique. Although adverse reactions to intravenous, intramuscular or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in man, experimental studies of small volume parenteral preparations containing 0.9% benzyl alcohol in several species of animals have indicated that an estimated intravenous dose up to 30 mL may be safely given to an adult without toxic effects. The most common side effects of H2Oinclude: Tell the doctor if you have any side effect that bothers you or that does not go away. However, this method requires special equipment and expertise. Follow medical advice and relevant indications for maximum safety and results when using bacteriostatic water for injections. Overdose & Contraindications OVERDOSE Use only as a diluent or solvent. It is only used for injections such as intravenous, intramuscular and subcutaneous. 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]. 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. If you are interested in using bacteriostatic water for injections, look no further! Gather the following: alcohol swabs, bacteriostatic water, peptide powder, and a sterile syringe. The site is secure. Bacteriostatic 0.9% Sodium Chloride (NaCl) Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride in water for injection. IMPORTANT - Use only Bacteriostatic Water for Injection with Benzyl Alcohol . Is Bacteriostatic Water The Same As Sterile Water? Reconstitution means a process that may be used to initiate a range of accountability actions to . Purchase your full kit today to safely use bacteriostatic water for injections. Bacteriostatic water is a sterile form of water that has been brought to a pH between 4.5 to 7.0. No information provided. Would love your thoughts, please comment. While you can go on to use the conventionally manual way to reconstitute peptides, it gets a whole lot easier to use the reconstitution calculator, and get the right dosage! How many mL are required for one dose? Also, nothing contained on this Website shall be interpreted as advising you. Bacteriostatic Water (Bacteriostatic Water for Injection - RxList It is also not known whether Bacteriostatic Water (bacteriostatic water (bacteriostatic water for injection) for injection) for Injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. See PRECAUTIONS. The packaged diluent (Bacteriostatic Water for Injection) contains benzyl alcohol as a preservative. We comply with the HONcode standard for trustworthy health information. When it comes to reconstituting peptides, there is a common question of whether bacteriostatic water is the same as sterile water. We partner major pharmaceutical companies in India & abroad as a reliable and efficient contract manufacturer. This method can preserve the peptides stability and activity for several months to years, depending on the peptides properties and storage conditions. Any individual seeking any advice on any prescription medication, or any disease or condition, is advised to refrain from using this site and consult their healthcare provider. Consult with pharmacist, if available. For more information, ask your doctor or pharmacist. 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. Providing a method for introducing the sterile moisture with uniformity may be difficult. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. Vaxxen Labs Reconstitution Solution (30 mL) 2 Pack Failure to do so risks the development of hemolysis, damaging the red blood cells [9, 10]. Good practice and a good quality assurance program would include the frequent monitoring of the volume of fill such as every 15 minutes. Our content is continually monitored by an internal peer-review process to ensure accuracy. This should hopefully shed some light on an easily confusing topic on which water to use. Before really going straight into the topic, lets first understand the need for the phrase reconstituting peptides. Composed of sterile water and 0.9% benzyl alcohol and an organic preservative agent, bacteriostatic water resists bacterial growth and contamination [1]. Although rarely, but they can occur, those side effects are more related to the drug that is dissolved in the bacteriostatic water. 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. Lets nail the major differences right from the start. Please enter the email address for your account. Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Lets just assume that you have been prescribed 500mcg of BPC 157. Package insert / product label Prior to buying anything, check that it is compliant where you live with your current government laws. Researchers also use organic solvent such as Acetic acid and DMSO to dissolve hydrophobic peptides and polar uncharged amino acids. But, for long-term storage of the powder form, the required temperature is less than -20 degrees celsius. Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic preservative. Use aseptic technique for single or multiple entry and withdrawal from all containers. Immediately you can gauge which is appropriate based on allergies. Call your doctor for medical advice about side effects. Bacteriostatic waters preservative content prevents contamination for multiple doses, while sterile water may be contaminated after one use. It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection. ITG SUBJECT: LYOPHILIZATION OF PARENTERALS. Sterile water is labeled for both injections and irrigations whereas bacteriostatic water is only labeled for injections. It depends on the compound, there is no universal conversion, About: Muscle and Brawn is a coaching company specializing in bodybuilding, hormones, peptides, anabolics, and other biohacking. publishing any Website material in any other media; selling, sublicensing and/or otherwise commercializing any Website material; publicly performing and/or showing any Website material; using this Website in any way that is or may be damaging to this Website; using this Website in any way that impacts user access to this Website; using this Website contrary to applicable laws and regulations, or in any way may cause harm to the Website, or to any person or business entity; engaging in any data mining, data harvesting, data extracting or any other similar activity in relation to this Website; using this Website to engage in any advertising or marketing. Stability data should be reviewed and the justification of the expiration date should be based on batches with the higher moisture content. For safe storage, adhere to manufacturer indications. This monograph has been modified to include the generic and brand name in many instances. Wipe down all materials with an alcohol swab. Here are some general guidelines for storing reconstituted peptides: Short-term storage: If you plan to use the reconstituted peptide within a few days, you can store it at 4C in the dark. Bacteriostatic Water may cause serious side effects including: Get medical help right away, if you have any of the symptoms listed above. Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) or 1.1% (11 mg/mL) benzyl alcohol added as a bacteriostatic preservative. ; "Manufacturing Economies and Product Improvement Through Advanced Freeze Drying Techniques"; Reprint of talk to Annual Meeting of Parenteral Drug Assn. As it cannot transfer pathogens, it is used mainly used in the medical field. Cookie Notice Carefully install the needle tip on a syringe. Due to the pH, a more apt solution for fluid replacement is normal saline or dextrose. You may be surprised to learn that they are not interchangeable [5]. The next and immediate step is to add the water you have drawn out into the peptide vial slowly yet smoothly. Peptide reconstitution is a complicated and confusing process for many. 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. Management of Drug Shortages with 0.9% Sodium Chloride, Sterile Water I'm diluting my AA (vinegar) to get to 0.6% AA. Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, . Sample 1 Sample 2 Sample 3. Air oxidation is yet another threat to the efficacy of the peptide, especially some peptides having amino acids such as free cysteine and tryptophan. Parenteral drug products should be inspected visually for particulate matter Any user ID and password you may have for this Website are confidential and you must maintain confidentiality as well. The safety and effectiveness of Bacteriostatic Water for Injection, USP have not been established in pediatric patients. Lets take a look at each one, where they differ, and where they overlap. Dont wait to enjoy the benefits of bacteriostatic water for injections. You may report side effects to FDA at 1-800-FDA-1088. ; New York City, Nov. 13, 1968. Distilled water is a form of sterile water but sterile water is not always distilled! Some of the important aspects of these operations include: the formulation of solutions; filling of vials and validation of the filling operation; sterilization and engineering aspects of the lyophilizer; and testing of the end product. Your Content must be your own and must not be invading any third-partys rights. Besides neonates, they both can be used for the rest of the population including pediatrics, adults and the geriatric community. 2) Decide how much reconstitution liquid you want to use to convert your lyophilized peptide into an injection-ready solution, and calculate the concentration of the solution. Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic preservative. To do the reconstitution of PT-141 you will need: Vial of PT-141 Vial of bacteriostatic water (or sterile water) This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Contact us at info@Bacteriostaticwater.com, Bacteriostatic Water vs. Sterile Water: The Differences That Can Save Your Life. 4 people found this helpful. Also, there should be provisions to isolate particular sections of the filling operations when low or high fills are encountered. How to Mix HCG (Human Gonadotropin) - Defy Medical Bacteriostatic Saline (Bacteriostatic NaCl): Uses, Dosage, Side Effects But, if there is an absolute need to stock solution form, what I would recommend is to store the required dosage into individual vials. Bacteriostatic Water is available generically and has the same name. How to Use HGH: Mixing, Reconstitution, Injecting Step By Step Guide However, some of the other dosage forms that are lyophilized, such as hydrocortisone sodium succinate and methylprednisolone sodium succinate have no antibacterial effect when in solution. We focus on finding the most accurate information from the scientific source. However, research is not considered conclusive. 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 solution, 0.50 osmolar; for the 125 mg per 2 mL solution, 0.40 osmolar; for the 1 gram per 8 mL solution, 0.44 osmolar; for the 2 gram per 30.6 mL solutions, 0.42 osmolar. Dr. Fouda uses his extensive knowledge and expertise as a neurosurgeon to medically review articles for accuracy and credibility, ensuring that the information presented is up-to-date and trustworthy. Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population. For these types of products, bioburden should be minimal and the bioburden should be determined prior to sterilization of these bulk solutions prior to filling. Due to the bacteriostat, bacteriostatic water comes in a multi-dose formulation for multiple uses. If the product is reconstituted with Sterile Water for Injection, USP, use immediately and discard any unused portion. Sterile water usually comes in single-unit doses and the reuse of units is prohibited. If symptoms appear, injections should be discontinued pending medical consultation [9]. In order to provide guidance and information to investigators, some industry procedures and deficiencies associated with lyophilized products are identified in this ITG. Yes, distilled water can also be used to reconstitute peptides alongside the bacteriostatic and sterile water. Reconstitution Solution versus Bacteriostatic Water. SIDE EFFECTS. Two sterile solutions that are commonly used are bacteriostatic water and sterile water. Bacteriostatic Water Vs. Sterile Water Bacteriostatic water and sterile water are essentially used for the same function which is to dissolve the drugs/medications for injecting purposes. The first step is to use the alcohol swab and wipe the vials containing lyophilized peptides and the bacteriostatic/sterile water. According to a recent study, 99.9% of people struggle with this step. However, if you can get your hands on some, then congratulations, youre already ahead of the game! Penetrate the peptide vial as gently as you can. Do NOT reuse the same saline syringe to flush VADs before and after medication administration. Ob es sich um die Verwaltung von Kundeninvestitionen oder einen umfassenden Plan fr sie zu schaffen und ihre Familie sind unsere zertifizierten Planern gewidmet mit einem auergewhnlichen Service zu bieten. 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. Bacteriostatic vs Sterile Water. Both may be used in the injection of peptides, hormones, and various medications, often reconstituted from lyophilized powder. Bacteriostatic Water for Injection: PI - Drugs.com These Terms constitute the entire agreement between Buckle LLC and you in relation to your use of this Website, and supersede all prior agreements and understandings. Obviously, the batching or compounding of these bulk solutions should be controlled in order to prevent any potential increase in microbiological levels that may occur up to the time that the bulk solutions are filtered (sterilized). 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. (Isotonic saline = 0.28 osmolar.) 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. Benzyl alcohol, a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in neonates. Be sure to consult indications for exact dosage and concentration. Also, if you are experimenting with new peptides, it is always best to use bacteriostatic water to dilute the peptides. From medications to peptides and hormones, bacteriostatic water is a winning option when it comes to reconstitution and sterility. The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. For the 5mg vial of BPC 157, you will have to use 1ml of bacteriostatic water. EZCORE INTERNATIONAL PVT. Reddit and its partners use cookies and similar technologies to provide you with a better experience. Additionally, this stability testing should include least concentrated as well as the most concentrated reconstituted solutions. Reconstitution Solution 4-Pack (30mL) Bactostatic Labs. We strive to never have a piece of inaccurate information on this website. 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. Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride in water for injection. 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. Reddit and its partners use cookies and similar technologies to provide you with a better experience. As discussed earlier, peptide mixing water is used to dissolve/dilute the lyophilized peptides. Bacteriostatic water is very easy to manufacture while sterile water is an arduous process. PDF Zomacton Description Another key difference is availability. Bacteriostatic water is contraindicated, or forbidden, from being used in neonates, newborns in the first 28 days of their life. The benzyl alcohol in the water makes bacteriostatic water ideal for diluting any drug that will be administered by intramuscular, intravenous, or subcutaneous injection. Perhaps other adverse effects include fever, abscess formation, thrombosis, tissue death, and infection. Well, people have been mixing peptides in the same syringe and then administering them. Shortage of sterile water and reconstitution of omalizumab It would ideally be either 0.3ml, 0.5ml or 1ml syringe. One would be used to control and record temperatures of the cycle as with sterilizers, and the other would be in the cold spot of the chamber. Lyophilized peptides are considerably stable at room temperature, so if you dont want to reconstitute the lyophilized peptide for some time, dont worry and just keep it a room temperature. 1. That means, they are single-dose vials and should be discarded after a single-use. Bacteriostatic water is commonly used for the injection of therapeutic compounds. Insert your needle tip into the sealed bottle of bacteriostatic water. If available, sonication may be performed in order to speed up the process. Both bacteriostatic water and sterile water are not used for straight injections, they have to be diluted with a drug or solvent. Privacy Policy. Peptides.org makes every effort to ensure that any information it shares complies with national and international standards for clinical trial information and is committed to the timely disclosure of the design and results of all interventional clinical studies for innovative treatments publicly available or that may be made available. Parenteral preparations containing benzyl alcohol should not be used in epidural or spinal anesthesia procedures. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. There may be cases in which sterile water is more appropriate, as outlined above. 3, pp. Where water is required for preparing or diluting medications for use in neonates, only preservative-free Sterile Water for Injection should be used. 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. There are not many side effects associated with using bacteriostatic water. Bacteriostatic Water for Injection, USP must be made approximately isotonic prior to use. Sorry Red, I was ambiguous with my 1st post. FDA indications vary regarding drug interactions. Bacteriostatic water and sterile water are essentially used for the same function which is to dissolve the drugs/medications for injecting purposes. Water for Injection, USP is chemically designated H2O. Do not use unless the solution is clear and seal intact. Slowly extract the bacteriostatic water until the solution reaches your desired level. 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. On the other hand, a sterile water vial doesnt contain any preservatives/additives which can keep it free of pathogens for a longer time, thus one will have to use it immediately after opening the seal. Some of the older lyophilizers cannot tolerate steam under pressure and sterilization is marginal at best. What is the difference between bacteriostatic water vs. sterile water for injection? Use only as a diluent or solvent. Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) or 1.1% (11 mg/mL) benzyl alcohol added as a bacteriostatic preservative. Bacteriostatic Water for Injection, USP containing additives should be given to a pregnant woman only if clearly needed. Its preservative content keeps it sterile to prevent infection, and its chemical properties allow it to efficiently dissolve solutes without compromising their integrity. 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. This website is using a security service to protect itself from online attacks. RedwolfWV Registered User Awards 1 May 24, 2008 #4 Ahh I get it. Reconstitution. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. Bacteriostatic Water for Injections | The A-Z Guide, Add a header to begin generating the table of contents. 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. Bacteriostatic Water vs "reconstitution solution" what's - Reddit Both sterile solutions are formulated for medical use. Once you have received the verification code, you will be able to choose a new password for your account. The preservative agent (0.9% benzyl alcohol) in bacteriostatic water allows packaging in multi-dose vials that resist contamination for up to 28 days when used with sterile needles. Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic preservative. Its like theyre a personal trainer, a nutritionist, and a beauty expert all rolled into one! Definitely be educated on the similarities and differences and have confidence when purchasing. Please let me know if you get an answer. 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. Because they are antibiotics, low bioburden of these formulations would be expected at the time of batching. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. As with any ethylene oxide treatment, humidification is necessary. Bacteriostatic Water vs. Sterile Water | Deus Medical Not only is this inefficient, but you may come across low-quality products from inferior manufacturers. The contents of Peptides.org are intended exclusively for qualified researchers. Contraindications for bacteriostatic water injections include newborn babies and cerebrospinal injections [2, 8]. For more information, please see our The clinical applications of the hormone hCG include fertility enhancement in both women and men, as well as a supplement to TRT in male subjects [17, 18]. [See USP Controlled Room Temperature. 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. 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. 5.0 out of 5 stars Good product. 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]. Plus, peptide solutions made with bacteriostatic water resist contamination. However, there are some differences between the two. It is commonly used to reconstitute or dilute therapeutic substances for injection, including intramuscular, intravenous, intradermal, and subcutaneous routes [1, 2]. When reconstituted with Bacteriostatic Water for Injection, USP, the resulting solution must be used within 7 days. Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride in water for injection. Your access to Peptides.org is subject to our full disclaimer and terms of use. It also is prepared with a bacteriostat, a compound used to prevent any bacterial growth. Buckle LLC reserves the right to remove any of Your Content from this Website at any time without notice. I have this same question. Do NOT use sterile water for injection for flushing VADs. When the lyophilized product does not include an excipient or other additive and only represents the active ingredient, weight variation can be employed as the means to test for dose uniformity. However, bacteriostatic water for injection may not be the best option in all cases, such as in neonatal or pregnant recipients, or in cases of subjects being administered certain medications [3, 5]. Bacteriostatic Water belongs to a class of drugs called Sterile Irrigating Solutions. Lets explore their points of similarity and difference to understand their appropriate uses. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. Short-term storage can be done at 4C, while long-term storage can be done by freezing at -20C or -80C, or by lyophilization. Okay, we made up that statistic, but its probably close to the truth. 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. This thread is archived Before sharing sensitive information, make sure you're on a federal government 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. How To Reconstitute PT-141 In Bacteriostatic Or Sterile Water It is simply water that has gone through purification and distillation processes for its safe use in various therapeutic contexts, namely injections, dilution, and irrigation. 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. This bacteriostat is usually 0.9% benzyl alcohol. The semi-rigid vial is fabricated from a specially formulated polyolefin. Due to the potential for toxicity, solutions containing benzyl alcohol should not be used in neonates. Handlers should follow the applicable dosage and administration schedule [16]. Benzyl alcohol can be a topical irritant but in the concentration of 0.9% does not typically cause irritation and may provide some anesthetic effects.