Raw material testing

This test measures the analyte concentration present in a given sample utilizing various techniques including High Performance Liquid Chromatography, Gas Chromatography, Ion Chromatography, Ultraviolet-Visible Spectroscopy, and Titrimetry.

Atomic absorption spectrophotometry (AAS) is used to measure the concentration of more than 70 elements in a liquid sample. In the pharmaceutical industry, it is commonly used to detect and quantify trace metals and inorganic impurities in raw materials, intermediates, and finished products.

USP, EP, BP and JP compendial testing qualifies drug substances and excipients as well as drug products to meet pharmacopeia specifications. Testing consists of procedures and acceptance criteria that help ensure the identity, strength, quality, and purity of the article.

This test confirms the identity of a substance by measuring how it absorbs infrared light and generating a unique spectrum, often referred to as a “fingerprint.” This spectrum is compared to a known reference standard from the United States Pharmacopeia (USP). A close match provides strong confirmation of the substance’s identity. Because many USP monographs rely on this approach, especially alongside UV absorption testing, it is widely accepted as a reliable way to verify what a material is, with very little uncertainty.

This test provides the identity of a substance using ultraviolet absorption spectrum compared to a USP reference standard. Conformance with both IR absorption and UV absorption test specifications, as called for in a large proportion of compendial monographs, leaves little doubt, if any, regarding the identity of the specimen under examination.

This test determines the amount of volatile matter driven off the sample under the conditions specified.

This test determines the temperature or temperature range at which a solid melts. This is often related to the purity of the substance.

A pH test measures the amount of acidity or basicity of a solution.

Residual Solvents are organic volatile chemicals that are used or produced in the manufacture of a drug substance or excipient, or in the preparation of drug products. Residual solvents should be removed, to the extent possible, to meet ingredient and product specifications, good manufacturing practices or other quality-based requirements. This test calculates the levels of residual solvents present in the product.

These tests measure the amount of inorganic residue remaining after a sample is burned at high temperature in the presence of sulfuric acid. The organic material is removed during ignition, leaving behind any non-volatile inorganic impurities. The remaining residue is weighed to determine the level of inorganic content, helping assess the purity of the material.

This test measures the ratio of a substance’s density compared to a reference standard, typically water. Specific gravity is an important property for characterizing liquids and solutions, helping to ensure consistency and quality in raw materials, formulations, and finished pharmaceutical products.

This test measures how resistant a liquid is to flowing, providing insight into its thickness or fluidity. In the pharmaceutical industry, viscosity is critical for ensuring consistent performance, proper dosing, and stability of liquid formulations, suspensions, and other products.

These tests measure the amount of water present in a sample. Water content can influence the results of other tests, such as assay, dissolution, and stability studies, making accurate measurement an important part of quality control and characterization of pharmaceutical materials.