Pharmaceutical Juice Analysis | Pharmaceutical Analysis

Pure Water, Water for Preparation of Extracts and Sterilized Water for Injection

Water used in pharmaceutical manufacturing processes is not only an excipient, but also an important component for the safety, efficacy and quality of the product. Especially in the context of pharmaceutical analysis, the quality of water is of great importance at every stage, from the preparation of raw material extracts to the production of injectable products.

Importance of Pharmaceutical Water

Water used in pharmaceutical production is not only a carrier medium but also involved in the dissolution of active pharmaceutical ingredients (APIs), excipients and cleaning processes. Therefore, the water to be used must be of high microbiological, chemical and physical purity. Any deviation in water quality can threaten product stability and patient safety.

1. Purified Water

Purified water is water that is free of ions, microorganisms and organic impurities. It is generally used in the production of non-injectable drug forms such as tablets, syrups and capsules.

Production Methods:

• Reverse osmosis (RO)
• Demineralization (ion exchange)
• Ultrafiltration
• Distillation

Analysis Parameters:

• Total organic carbon (TOC)
• Conductivity (≤1.3 µS/cm @25°C)
• Microbiological count (CFU/mL)
• pH value
• Nitrate and heavy metal analysis

2. Water Used for Preparation of Extracts

Area of Use:

In herbal medicine production, it is used to dissolve and extract the active components of plant materials. The quality of the water used in this process directly affects the purity of the extract.

Featured Analyses:

• Microbiological controls (especially fungal and mold counts)
• Pesticide and heavy metal residues
• Organic pollution analysis
• pH and dissolved oxygen measurements

The temperature and pH of the water used during extraction can affect the type and amount of components to be obtained. It is therefore important to use water under controlled conditions.

3. Sterilized Water for Injection (WFI)

Sterile water for injection is a highly pure type of water used to dilute or dissolve drugs for intravenous (IV), intramuscular (IM) or subcutaneous administration.

Characteristics:

• Must not contain pyrogens (especially endotoxin tests are performed)
• Must besterile
• Completely free of microorganisms
• Minimal chemical and ionic impurities

Production Methods:

• Distillation (especially multi-column distillation systems)
• Ultrafiltration (in some cases)

Analysis Parameters:

• Bacterial endotoxin test (LAL test)
• Sterility testing
• Conductivity and TOC
• Microbiological limit tests

Standards to be followed in Pharmaceutical Water Analysis

Water analyses should be performed according to international standards, especially USP (United States Pharmacopeia), EP (European Pharmacopoeia) and ICH guidelines. In Turkey, TİTCK (Turkish Medicines and Medical Devices Agency ) and GMP (Good Manufacturing Practices ) requirements should also be taken into account.

Nanolab Laboratories Group continues to provide services within the scope of Pharmaceutical Analysis. You can also consult us on Nitrosamine Analysis.

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