Other analytical tests
Optional Tests for Other analytical tests
UV/visible spectrophotometer scan
The USP Light Transmission test is designed to measure the amount of light transmitted by either transparent or translucent glass or plastic materials used for pharmaceutical or medical containers. The USP Light Transmission test is intended to be used where a container is to provide protection from light or offered as a "light-resistant" container.
Total organic carbon (TOC), O.I., USP 643, EP 2.2.44 USP 643, EP 2.2.44
Total Organic Carbon (TOC) Analysis is used to establish the amount of organic compounds in purified water, medical device extracts, or rinses. Total organic carbon analysis is used to determine if purified water meets the specifications according to the United States Pharmacopeia (USP). This test can also be used as a process control to monitor the performance of unit operations comprising water purification and distribution systems. Organic carbon molecules can be introduced into the water from purification and distribution system materials and from biofilm growing in the system. Extracts from medical devices can be analyzed for TOC to determine cleaning material residuals. TOC analysis can also be used in cleaning validations for pharmaceutical applications. Swabs or rinses from pharmaceutical production equipment can be analyzed by TOC to prove the effectiveness and consistency in the cleaning of the production equipment.
Sodium chloride assay
This test is for the determination of sodium chloride (NaCl) content in test samples. It employs the intent and content of the USP methodology and can help determine if a sample meets the USP requirements. This test can be used for assays of sodium chloride injection, sodium chloride inhalation, etc. (USP test methods are similar in design).
Sodium benzoate analysis
Sodium benzoate is often used as an antimicrobial agent to preserve food. It is a preservative that is regulated by the US Food and Drug Administration (FDA) in the Code of Federal Regulations (21CFR Part 184.1733). The concentration should not exceed 0.1% in food. We have established a validated test method for the quantitative analysis of sodium benzoate by high-performance liquid chromatography (HPLC). This will be able to tell how much sodium benzoate is in a sample to ensure that it meets the regulated limit.
Conductivity USP 645, EP 2.2.44
The combined conductivities of the intrinsic and extraneous ions vary as a function of pH and are the foundation for the conductivity requirements found in the USP.
Oxidizable substances
Oxidizable substances readily lose electrons. Common examples are iron, copper, zinc, carbon, hydrogen, and most organic compounds. Oxidizable substances consume added potassium permanganate when boiled.
pH analysis
This test determined the pH of a solution using pH meters. This procedure is necessary to ensure that an accurate pH value for a solution is attained.
