First, lets break down the basics of sterile water. Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population. Most peptides that you will see are often sold as lyophilized peptides which means that (freeze-dried) powder form. Purchase your full kit today to safely use bacteriostatic water for injections. 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. 1996-2023 RxList, Inc. An Internet Brands company. In a nutshell, in order to make the 1 proper dosage of BPC-157, you would need to draw 10 units of water and then mix it by following the reconstitution guidelines. Carefully install the needle tip on a syringe. The process is simple. 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. Good practice for the compounding of lyophilized products would also include batching in a controlled environment and in sealed tanks, particularly if the solution is to be stored prior to sterilization. Well, people have been mixing peptides in the same syringe and then administering them. Products are manufactured in the lyophilized form due to their instability when in solution. 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. It also is prepared with a bacteriostat, a compound used to prevent any bacterial growth. Lysis is the breaking down of a cell or membrane. A major difference between the two is the patient population. However, you are not allowed to assign, transfer, or subcontract any of your rights and/or obligations under these Terms. As defined in Section 10.01. The process of reconstitution is the same regardless of what kind of water you chose to reconstitute your AOD with. But not all peptides dissolve in water easily, so it usually is recommended that you try to dissolve the peptide in any of these waters using Sonication. Unlike a powder or liquid fill, a low fill would not be readily apparent after lyophilization. So, you will need alcohol swabs, a syringe (27-29 gauge insulin needles), the lyophilized peptide that you have ordered, and the bacteriostatic water or sterile water, depending on your preference. Create your account and enjoy a new shopping experience. I have this same question. Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic preservative. Need to know how much to buy. 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. The proper reconstitution of HGH before injection closely follows the above method. 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. 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. Administration of an estimated 9 mL to a 6 kg infant or neonate is potentially capable of producing blood pressure changes. Before digging deeper into precise conditions required to store peptides, you should know that keeping a peptide vial away from intense light, high temperature and moisture is a MUST. Do not use Bacteriostatic Water (bacteriostatic water (bacteriostatic water for injection) for injection) for Injection, USP for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. Please refer to the WARNINGS Check a preview below or click on the image to see the full document. Performance & security by Cloudflare. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. However, when excipients or other additives are present, weight variation may be applied provided there is correlation with the sample weight and potency results. Bacteriostatic water is contraindicated, or forbidden, from being used in neonates, newborns in the first 28 days of their life. Shortage of sterile water and reconstitution of omalizumab If you are interested in using bacteriostatic water for injections, look no further! Peptide Reconstitution + Mixing Guide With Calculator - Muscle and Brawn This website is using a security service to protect itself from online attacks. For more information, please see our 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. A major concern with the filling operation is assurance of fill volumes. .063 mg/mL, 3200 mL c. 1000 mg/mL, 5 mL d. 64 mg/mL b. 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. Another difference is indications. This bacteriostat is usually 0.9% benzyl alcohol. On the other hand, if the peptide vial has been reconstituted, make sure that you store it between 2 and 8 degrees celsius because the reconstituted peptides are susceptible to minor temperature changes. For those of you thinking about the volume of water, 1ml is usually enough for all the peptides available in the market. Two sterile solutions that are commonly used are bacteriostatic water and sterile water. Inspection Technical Guides, Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations. Nothing really. Definitely be educated on the similarities and differences and have confidence when purchasing. Once vials are partially stoppered, they are transported to the lyophilizer. Deshalb, im Laufe der Jahre konnten wir einen Ruf als einer der besten unabhngigen Beratern zu bauen. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. 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. First, you want to thoroughly wash your hands with soap and water for at least 20 seconds. Leucovorin Calcium - GlobalRPH They quickly get ruined by heating, even room temperatures, and vigorous movement. Not only is this inefficient, but you may come across low-quality products from inferior manufacturers. By using this Website, you agreed to accept all terms and conditions written in here. Reconstitute Definition & Meaning - Merriam-Webster 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. Long-term storage: For long-term storage, it is recommended to aliquot the reconstituted peptide into small volumes and freeze them at -20C or -80C. IMPORTANT - Use only Bacteriostatic Water for Injection with Benzyl Alcohol . Drug class: Sterile irrigating solutions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. By displaying Your Content, you grant Buckle LLC a non-exclusive, worldwide irrevocable, sub licensable license to use, reproduce, adapt, publish, translate and distribute it in any and all media. Bacteriostatic water and sterile water are essentially used for the same function which is to dissolve the drugs/medications for injecting purposes. Data are unavailable on the toxicity of other preservatives in this age group. Insert your needle tip into the sealed bottle of bacteriostatic water. Do not use unless the solution is clear and seal intact. The sterilization of the lyophilizer is one of the most frequently encountered problems. Both bacteriostatic water and sterile water are not used for straight injections, they have to be diluted with a drug or solvent. How to Properly Reconstitute AOD 9604 + Dose Measurement As with any ethylene oxide treatment, humidification is necessary. Warning:The content on Muscleandbrawn.com and the information included in this article is intended for entertainment and informational purposes only. Once you open the seal of the sterile water vial, you will either have to use it preferably within the next 4 hours or discard it. Call your doctor for medical advice about side effects. 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. Bacteriostatic Water vs reconstitution solution whats the difference? ; "Manufacturing Economies and Product Improvement Through Advanced Freeze Drying Techniques"; Reprint of talk to Annual Meeting of Parenteral Drug Assn. Please include what you were doing when this page came up and the Cloudflare Ray ID found at the bottom of this page. The struggle is real, people. Immediately you can gauge which is appropriate based on allergies. It would seem very difficult for a manufacturer to be able to demonstrate satisfactory validation of sterilization of a lyophilizer by chemical "treatment.". Peptide Reconstitution: Dosing, Mixing and Storage Guidelines 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. It is only used for injections such as intravenous, intramuscular and subcutaneous. May contain hydrochloric acid for pH adjustment. Once you have put the details, our reconstitution calculator will use its algorithm and devise the volume needed to get your peptides reconstituted! RxList does not provide medical advice, diagnosis or treatment. Reconstitution Solution versus Bacteriostatic Water : r/Peptides - Reddit Medications that required diluting with water usually indicate on the bottle which water is preferred for use. You should never inject bacteriostatic water without mixing in any medications because the benzyl alcohol in it causes the red blood cell lysis. 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 . and our Bacteriostatic Water for Injection, USP must be made approximately isotonic prior to use. Both may be used in the injection of peptides, hormones, and various medications, often reconstituted from lyophilized powder. Bacteriostatic Water is available generically and has the same name. These Terms will be governed by and interpreted in accordance with the laws of the State of New York, and you submit to the non-exclusive jurisdiction of the state and federal courts located in New York for the resolution of any disputes. Provisions for sterilizing and assuring the integrity of vent filters or filters used to sterilize the inert gas and air. This thread is archived Provisions for sterilizing the inert gas or air supply lines. The .gov means its official.Federal government websites often end in .gov or .mil. These include subcutaneous, intramuscular, intravenous, and intradermal injection routes [. 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. The benzyl alcohol in the water makes bacteriostatic water ideal for diluting any drug that will be administered by intramuscular, intravenous, or subcutaneous injection. Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride in water for injection. We partner major pharmaceutical companies in India & abroad as a reliable and efficient contract manufacturer. Cloudflare Ray ID: 7c0dd6108cb23fde How many mL are required for one dose? Using either in the proper conditions can provide extraordinary results. 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. Administration of an estimated 9 mL to a 6 kg infant or neonate is potentially capable of producing blood pressure changes. See PRECAUTIONS. Bacteriostatic water works well as a peptide solvent, reconstituting the compounds without compromising their effectiveness. Bacteriostatic Water for Peptides | Learn How to Prepare Bacteriostatic 5.161.53.20 Bacteriostatic water is a sterile form of water that has been brought to a pH between 4.5 to 7.0. It is not intended nor implied to be a substitute for professional medical advice. 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.. What Is Bacteriostatic Water For Peptide Reconstitution In order to provide guidance and information to investigators, some industry procedures and deficiencies associated with lyophilized products are identified in this ITG. All rights reserved. Sterile water is labeled for both injections and irrigations whereas bacteriostatic water is only labeled for injections. Bacteriostatic water is very easy to manufacture while sterile water is an arduous process. Our focus is to exclusively link to peer-reviewed studies found on respected websites, like PubMed. Prior to buying anything, check that it is compliant where you live with your current government laws. [See USP Controlled Room Temperature. More posts from r/Peptides 46K subscribers Hour_Love5645 6 days ago NSFW On the insulin syringe, 100 units correspond to 1ml, so 10 units will correspond to 0.1ml of the bacteriostatic water. Touched on earlier, another key difference is multiple uses. Complement your research with this USP solvent, the go-to solution of the medical and scientific community. 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. Bacteriostatic Water (Bacteriostatic Water for Injection - RxList 5.0 out of 5 stars Good product. Data are unavailable on the toxicity of other preservatives in this age group. Lets explore their points of similarity and difference to understand their appropriate uses. Wipe down all materials with an alcohol swab. Injection of HGH is considered safe when prescribed by a doctor. Before really going straight into the topic, lets first understand the need for the phrase reconstituting peptides. Bacteriostatic water works well as a peptide solvent, reconstituting the compounds without compromising their effectiveness. For intravenous infusion, first prepare solution by adding not more than 2 mL of Bacteriostatic Water for Injection to the vial; this solution may then be added to 100 . It is a copolymer of ethylene and propylene. Performance & security by Cloudflare. Allow the powder to naturally dissolve until the vial is transparent. 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. As it cannot transfer pathogens, it is used mainly used in the medical field. The recommended dosage of BPC 157 is somewhere between 200mcg to 1000mcg, depending on your body weight. The action you just performed triggered the security solution. Once you have put the details, our reconstitution calculator will use its algorithm and devise the volume needed to get your peptides reconstituted! Do NOT reuse the same saline syringe to flush VADs before and after medication administration. For the reconstitution of HGH powder, bacteriostatic water is a great choice, as it preserves HGH solutions and efficiently dissolves lyophilized aggregates [16]. 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. Where water is required for preparing or diluting medications for use in neonates, only preservative-free Sterile Water for Injection should be used. Its like a chemistry experiment, but instead of blowing things up, youll be improving your health. Once the peptide is really made soluble in any of the relevant solutions, diluting it with bacteriostatic water or sterile water is recommended. Now, before you start flexing your peptide muscles, you need to learn the proper way to reconstitute them. Then you're in luck! From medications to peptides and hormones, bacteriostatic water is a winning option when it comes to reconstitution and sterility. Obviously, there is a much greater chance of contamination in this type of operation because of the involvement of people. 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. As I mentioned at the start, the sterile water vial doesnt contain benzyl alcohol which makes it unfavorable for storage. Beisswenger, H.L. 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. The dosage and administration schedule should follow applicable recommendations [18, 19]. Recommended dosage guidelines are usually based on either the clinical trials or the efficacy of the peptide. 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. 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. Some drugs can interact poorly with each solvent, and they are not considered universally interchangeable in clinical contexts. Due to the potential for toxicity, solutions containing benzyl alcohol should not be used in neonates. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. Before sharing sensitive information, make sure you're on a federal government site. Reconstituted peptides can be stored in several ways, depending on the duration of storage and the desired shelf life. 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. Benzyl alcohol, a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in neonates. Wir verstehen die Bedeutung der Kunden auf dem richtigen Weg zum Erfolg bringen, und wir sind bereit, mit ihnen der Planung in allen Bereichen zu arbeiten. 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]. Always use as directed on the label. Withdraw approximately 1mL of bacteriostatic water from the vial and slowly transfer it into the peptide container. By rejecting non-essential cookies, Reddit may still use certain cookies to ensure the proper functionality of our platform. Correctly reconstituting peptides is essential in their effectiveness. Generally lyophilized products have short expiration dates. It is recognized that there is complex technology associated with the manufacture and control of a lyophilized pharmaceutical dosage form. 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. Validation of these types of filling operations should include media fills and the sampling of critical surfaces and air during active filling (dynamic conditions). Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride in water for injection. Bacteriostatic water formulations for injection have pH levels of 4.5-7, averaging 5.7. Our content is continually monitored by an internal peer-review process to ensure accuracy. However, they do differ in their composition as the bacteriostatic water contains 0.9% benzyl alcohol as a preservative. 4 people found this helpful. Bacteriostatic Water may be used alone or with other medications. Parenteral preparations with benzyl alcohol should not be used for fluid replacement. But, for long-term storage of the powder form, the required temperature is less than -20 degrees celsius. Sample 1 Sample 2 Sample 3. Bacteriostatic Water SOLU-CORTEF Dosage and Administration (hydrocortisone sodium succinate LTD.Salt Lake Electronics ComplexEP Block, Sector V, BidhannagarKolkata, West Bengal 700091, INDIA. Now here comes the crux of the article after talking about some of the major prerequisites of the peptide reconstitution process. ZOMACTON 10 mg reconstituted with bacteriostatic water for injection containing 0.33% metacresol should not be used if the patient is allergic to metacresol. This can come into play when preparing for traveling, budgeting monthly expenses and storage. Reconstitution Definition & Meaning | Merriam-Webster Medical Any user ID and password you may have for this Website are confidential and you must maintain confidentiality as well. Should I dilute with sterile water (USP grade) or BW? 51.222.156.250 PHARM TEST #2: Reconstitution Flashcards | Quizlet 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. However, research is not considered conclusive. How to Mix HCG (Human Gonadotropin) - Defy Medical Bacteriostatic Water may cause serious side effects including: Get medical help right away, if you have any of the symptoms listed above. 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. Providing a method for introducing the sterile moisture with uniformity may be difficult. Privacy Policy. Based on 26 documents. pose a threat of fluid overload except possibly in very small infants. Slowly extract the bacteriostatic water until the solution reaches your desired level. 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. Okay, we made up that statistic, but its probably close to the truth. You will soon see that your peptide powder will be dissolved and the vial will be transparent. Obviously, a low fill would represent a subpotency in the vial. Good practice and a good quality assurance program would include the frequent monitoring of the volume of fill such as every 15 minutes. 100 mg Plain. and our 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. If you feel that any of our content is inaccurate or out-of-date, please contact us at: [emailprotected]. 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. This would kill 2 birds with one stone as not only this will solve the storage problem but repeated refrigerating and thawing is also a possible risk factor so you avoid that too! Report. Additionally, bacteriostatic water must always be mixed with a solute before injection. (I would personally recommend bacteriostatic water because of its longer shelf-life). Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic preservative. Composed of sterile water and 0.9% benzyl alcohol and an organic preservative agent, bacteriostatic water resists bacterial growth and contamination [1]. There have been times when sterile water has been in short supply. Read more. Though their features overlap, bacteriostatic water and sterile water have several significant differences. Management of Drug Shortages with 0.9% Sodium Chloride, Sterile Water This bacteriostat is usually 0.9% benzyl alcohol. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. SIDE EFFECTS. 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. See WARNINGS, PRECAUTIONS Although rarely, but they can occur, those side effects are more related to the drug that is dissolved in the bacteriostatic water. Any transfer and handling, such as loading of the lyophilizer, should take place under primary barriers, such as laminar flow hoods under which the vials were filled. Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. How To Reconstitute PT-141 In Bacteriostatic Or Sterile Water Benzyl alcohol, a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in neonates. 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. For safe storage, adhere to manufacturer indications. They both are nonpyrogenic meaning they wont cause fever. Vaxxen Labs Reconstitution Solution (30 mL) 2 Pack Once a vial of bacteriostatic water is opened, the benzyl alcohol will usually prevent the growth of bacteria for up to 28 days. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. To really know the best solvent in which a peptide will be soluble, you must have to consider some biochemistry knowledge and do some trial and error. Using in such a matter can cause hemolysis or destruction of red blood cells. No information provided. Sterile water is purified water that has been distilled and brought to a pH between 5.0 to 7.0. Avoid repeated freeze-thaw cycles: It is essential to avoid repeated freeze-thaw cycles, as they can cause damage to the peptide and decrease its stability and activity. Plus, peptide solutions made with bacteriostatic water resist contamination. Use aseptic technique for single or multiple entry and withdrawal from all containers.
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