Introduction to the Uses, Dosage, and Pharmacopoeia Standards of Medicinal-Grade Sterile Water for Injection

Introduction to the Functions, Usage, Dosage, and Pharmacopoeia Standards of Pharmaceutical-Grade Sterile Water for Injection

Pharmaceutical-grade sterile water for injection (Sterile Water for Injection, USP) is a fundamental medication commonly used in healthcare. It is sterile water used for preparing drug solutions, undergoing rigorous sterilization and filtration processes to ensure it is free from any microbial contamination, making it suitable for injection or intravenous infusion. It serves as a solvent or diluent for various pharmaceutical preparations and is widely used in medical institutions such as hospitals and clinics.

I. Basic Overview of Pharmaceutical-Grade Sterile Water for Injection

Definition: Pharmaceutical-grade sterile water for injection is water specifically designed for injection or intravenous infusion. It must undergo strict sterilization to ensure it is free from contamination, guaranteeing that it does not cause any infection or adverse reactions in patients during medical applications.

Characteristics:

1. Sterility: Sterile water for injection must undergo high-temperature sterilization to ensure it is free from any microbial, bacterial, fungal, or other biological contamination.

2. No Additives: This water contains no drugs or solvent additives, and its pH value, inorganic salts, etc., should be within suitable ranges to avoid any adverse reactions in the human body.

3. High Purity: The purity of water for injection is extremely high, with almost no dissolved organic or inorganic substances, and its ion and electrolyte content is very low.

4. Suitable for Injection: Primarily used for dissolving or diluting drugs for intravenous injection, intramuscular injection, subcutaneous injection, etc.

Introduction to the Functions, Usage, Dosage, and Pharmacopoeia Standards of Pharmaceutical-Grade Sterile Water for Injection

Sterile water for injection (Sterile Water for Injection) is a colorless, odorless, clear liquid prepared from water for injection using injection manufacturing processes. Its acidity or alkalinity (pH) is specified to be between 5.0 and 7.0, and all tests must comply with the relevant regulations for injections. It is used as a solvent for sterile powders for injection or as a liquid preparation for flushing various endoscopic procedures.

The main component of sterile water for injection is water for injection, which is processed under special conditions to create a sterile preparation suitable for injection. It is a colorless, odorless, clear liquid.

In clinical practice, sterile water for injection is primarily used as a solvent for sterile powders for injection or as a diluent for injections. It can also be used as a flushing agent in urological endoscopic surgeries. Many people often mistake water for injection for sterile water for injection, but there is a difference between the two. Water for injection is obtained by distilling purified water and must meet the requirements for bacterial endotoxin testing; it is also known as pyrogen-free water. Water for injection must be stored and packaged under conditions designed to prevent endotoxin production. It can be used as a solvent for preparing injections, a diluent, or for rinsing injection containers. When necessary, it can also serve as a solvent for preparing eye drops. Sterile water for injection, on the other hand, is water for injection that has been sterilized, resulting in water that is sterile and pyrogen-free. It is mainly used as a solvent for sterile powders for injection or as a diluent for injections.

Sterile water for injection is obtained by sterilizing water for injection, and its quality requirements are higher. It is hypotonic, with a pH value between 5.0 and 7.0.

Because water for injection is a hypotonic solution, its osmotic pressure is lower than that of human tissue fluid. When mixed with tissue fluid, water rapidly enters the cells, causing them to swell and leading to local pain. This pain stimulates the skin, causing local congestion and flushing, which may result in a false positive reaction.

Currently, the commercially available specifications of sterile water for injection in China are: 1ml, 2ml, 5ml, 10ml, 20ml, 50ml, 75ml, 100ml, 250ml, 500ml, 1000ml, 2000ml, and 3000ml. Containers vary based on volume and include: glass ampoules, glass infusion bottles, polypropylene infusion bottles, composite film infusion bags, non-PVC soft bags, etc. According to pharmacopoeia standards, sterile water for injection is primarily used as a solvent and flushing agent in clinical practice. In actual clinical use, it is also employed as a humidifying liquid for patients receiving oxygen therapy.