Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population. IMPORTANT Use only the accompanying diluent or Bacteriostatic Water For Injection with. Peptides the proteins little brother can do wonders for our bodies! It would seem very difficult for a manufacturer to be able to demonstrate satisfactory validation of sterilization of a lyophilizer by chemical "treatment.". However, there are some differences between the two. Bacteriostatic water (BW) has a pH of about 5.7. 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. Water balance is maintained by various regulatory mechanisms. We partner major pharmaceutical companies in India & abroad as a reliable and efficient contract manufacturer. Good practice and a good quality assurance program would include the frequent monitoring of the volume of fill such as every 15 minutes. Often available as a lyophilized powder, hCG is best reconstituted with bacteriostatic water for injection due to the solvents efficiency and preservative agents. Many people have this mentality that bacteriostatic water and sterile water are the same thing, and that can bring disastrous results. You may be surprised to learn that they are not interchangeable [5]. It is considered an ideal sterile solution due to its low toxicity and minimal interference with drug effectiveness. They quickly get ruined by heating, even room temperatures, and vigorous movement. You must not use this Website if you disagree with any of these Website Standard Terms and Conditions. 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. did you ever get an answer? The sterilization of the lyophilizer is one of the most frequently encountered problems. Sterile water is labeled for both injections and irrigations whereas bacteriostatic water is only labeled for injections. Obviously, a low fill would represent a subpotency in the vial. Where water is required for preparing or diluting medications for use in neonates, only preservative-free Sterile Water for Injection should be used. Both meet US Pharmacopeia (USP) standards. 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! FDA rev date: 6/15/2000. Archived post. 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. Parenteral preparations with benzyl alcohol should not be used for fluid replacement. Lets just assume that you have been prescribed 500mcg of BPC 157. While there is no fixed dosage of peptides and each peptide accounts for a different dose. 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 . 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]. Data are unavailable on the toxicity of other preservatives in this age group. Step 1: Wash your hands and gather your materials. [See USP Controlled Room Temperature. Reconstitution instructions: Reconstitute with 15.6 mL of bacteriostatic water for a total volume of 16 mL. Benzyl alcohol, a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in neonates. It is essential to avoid exposure to light and high temperatures, which can lead to peptide degradation. Made with the organic preservative benzyl alcohol, this solution resists contamination to enable multiple doses per vial. LTD.Salt Lake Electronics ComplexEP Block, Sector V, BidhannagarKolkata, West Bengal 700091, INDIA. Nothing really. Although both of these types of water are sterile, the difference between bacteriostatic water and sterile water is that other sterile waters for injection do not contain a bacteriostatic agent. Animal reproduction studies have not been conducted with Bacteriostatic Water (bacteriostatic water for injection) for Injection. 3) Choose the size of the syringe you want . The packaged diluent (Bacteriostatic Water for Injection) contains benzyl alcohol as a preservative. How many mL are required for one dose? 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. Dont waste time and energy attempting to source syringes, alcohol swabs, and bacteriostatic water from multiple retailers. Parenteral preparations containing benzyl alcohol should not be used in epidural or spinal anesthesia procedures. Both substances are sterile solvents formulated for use in medical settings. May contain hydrochloric acid for pH adjustment. Composed of sterile water and 0.9% benzyl alcohol and an organic preservative agent, bacteriostatic water resists bacterial growth and contamination [1]. Failure to do so risks the development of hemolysis, damaging the red blood cells [9, 10]. Warning:The content on Muscleandbrawn.com and the information included in this article is intended for entertainment and informational purposes only. Somatropin should not be used for. On the insulin syringe, 100 units correspond to 1ml, so 10 units will correspond to 0.1ml of the bacteriostatic water. Due to the lack of antimicrobials, sterile water can easily be contaminated once exposed to surroundings and even yourself. Flamberg, DW; "Manufacturing Considerations in the Lyophilization of Parenteral Products"; Pharmaceutical Manufacturing, Volume 3, No. Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population. For those of you thinking about the volume of water, 1ml is usually enough for all the peptides available in the market. Bacteriostatic water works well as a peptide solvent, reconstituting the compounds without compromising their effectiveness. Bacteriostatic Water for Injection, USP containing additives should be given to a pregnant woman only if clearly needed. Administration of an estimated 9 mL to a 6 kg infant or neonate is potentially capable of producing blood pressure changes. 3, pp. First, you want to thoroughly wash your hands with soap and water for at least 20 seconds. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. Many of the antibiotics, such as some of the semi-synthetic penicillins, cephalosporins, and also some of the salts of erythromycin, doxycycline and chloramphenicol are made by the lyophilization process. 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. Before really going straight into the topic, lets first understand the need for the phrase reconstituting peptides. The recommended dosage of BPC 157 is somewhere between 200mcg to 1000mcg, depending on your body weight. For safe storage, adhere to manufacturer indications. In summary, the best way to store reconstituted peptides depends on the duration of storage and the desired shelf life. Providing a method for introducing the sterile moisture with uniformity may be difficult. Reconstituted peptides can be stored in several ways, depending on the duration of storage and the desired shelf life. The Buckle LLC is allowed to assign, transfer, and subcontract its rights and/or obligations under these Terms without any notification. If you are a peptide researcher or laboratory professional, you can safely enjoy the benefits of bacteriostatic water with proper use. 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. These Terms will be applied fully and affect to your use of this Website. Obviously, there is a much greater chance of contamination in this type of operation because of the involvement of people. RedwolfWV Registered User Awards 1 May 24, 2008 #4 Ahh I get it. We strive to never have a piece of inaccurate information on this website. Lets nail the major differences right from the start. First, lets break down the basics of sterile water. There are several actions that could trigger this block including submitting a certain word or phrase, a SQL command or malformed data. However, this method requires special equipment and expertise. The universal rule is to use 1 milliliter of bacteriostatic water for every peptide that you reconstitute. 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. Administration of an estimated 9 mL to a 6 kg infant or neonate is potentially capable of producing blood pressure changes. Pregnancy: Animal reproduction studies have not been conducted with Bacteriostatic Water for Injection. A verification code will be sent to you. Bacteriostatic Water for Injection Prescribing Information. 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. If you are interested in using bacteriostatic water for injections, look no further! Because many of the types of products are antibiotics, subpotency in a vial can present a potentially very serious situation. These include subcutaneous, intramuscular, intravenous, and intradermal injection routes [. The filling of vials that are to be lyophilized has some problems that are somewhat unique. The proper reconstitution of HGH before injection closely follows the above method. Based on 31 documents. The first step is to use the alcohol swab and wipe the vials containing lyophilized peptides and the bacteriostatic/sterile water. Because there is 1ml of bacteriostatic water, this means that we need to mix 5000mcg with 1ml of bacteriostatic water. May contain hydrochloric acid for pH adjustment. So, the former is available in multi-dose containers that are viable for up to 28 days after opening, while sterile water comes in single-dose vials. You don't use either to reconstitute it. Use aseptic technique for single or multiple entry and withdrawal from all containers. Reconstitution follows the above method. See WARNINGS, PRECAUTIONS You may report side effects to FDA at 1-800-FDA-1088. 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. The next and immediate step is to add the water you have drawn out into the peptide vial slowly yet smoothly. Contact us at info@Bacteriostaticwater.com, Bacteriostatic Water vs. Sterile Water: The Differences That Can Save Your Life. (I would personally recommend bacteriostatic water because of its longer shelf-life). Consult with pharmacist, if available. Reconstitution Solution 4-Pack (30mL) Bactostatic Labs. Made with Muscle. Some measures are necessary - do not inject the water straight into the powder with force, usually, do not drop or shake a reconstituted vial. 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. It may be wise to always opt for bacteriostatic water if both water types are allowed for use. It is recognized that there is complex technology associated with the manufacture and control of a lyophilized pharmaceutical dosage form. 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. Why is Water Essential to Reconstitution? .063 mg/mL, 3200 mL c. 1000 mg/mL, 5 mL d. 64 mg/mL b. Buckle LLC reserves the right to remove any of Your Content from this Website at any time without notice. As the title suggestswhats the difference between bacteriostatic water and reconstitution solution? 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. 5.0 out of 5 stars Good product. Use aseptic technique for single or multiple entry and withdrawal from all containers. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. Some drugs can interact poorly with each solvent, and they are not considered universally interchangeable in clinical contexts. HCG solutions are to be refrigerated to prevent degradation [19]. Provisions for sterilizing and assuring the integrity of vent filters or filters used to sterilize the inert gas and air. Although products may be labeled for reconstitution with Bacteriostatic Water for Injection, Sterile Water for Injection (WFI) should be used to reconstitute products. Bacteriostatic water should not be used on individuals with benzyl alcohol allergies. The semi-rigid vial is fabricated from a specially formulated polyolefin. 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. During peptide reconstitution, two variations of solutions are popular. If symptoms appear, injections should be discontinued pending medical consultation [9]. Peptide Reconstitution + Mixing Guide with Calculator, Read the full review on BPC 157 only at Muscle and Brawn, Limitless Life Nootropics (and Peptides) Review, Epitalon Peptide Guide: Benefits, Uses, Dosage, How to Safely Use SARMs to Sculpt Three-Dimensional Muscles and Torch Fat, The ONE Thing You MUST do Before starting SARMs if You Want to Keep Yourself Out of the Hospital, The MILDEST SARM that gives you gains without all the bloating, How to Properly Use SARMs to build 3D Muscles Without Experiencing Sloppy Noodle Syndrome. 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. 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.