Raw materials, also known as feedstock or unprocessed materials, are the basic materials from which products are made. Raw materials are materials or substances used in the primary production or manufacturing of goods.
In the pharmaceutical industry, raw materials are generally categorized, into three major types: Raw Materials of Excipients, Raw Materials of API, and Raw Materials of Packaging. Excipients, also called drug carriers, are the carrier material in any drug. The raw material of excipients include solvents and other carriers, which are capable of carrying the actual drug. API, or active pharmaceutical ingredient, is the component of the drug that is responsible for drug action. Precision and accuracy of the API are crucial as any small deviation in the composition can lead to a dramatic change to the over product.
Before manufacturing a drug product, the FDA requires that the raw materials are tested to establish their identity, purity, and quality. This analysis is crucial in the manufacturing process to ensure that the product is safe in its intended use. Since testing of the raw materials must be completed before product release, speed and accuracy are paramount.
USP monographs, which include several different analytical techniques, are provided for some of the most commonly used raw materials in the industry, USP methods are provided. Karl Fischer moisture analysis, pH, viscosity, and titrations are common but more complex techniques such as HPLC, GC-MS, and ICP-MS are sometimes required.
ChRi Labs is both FDA registered and cGMP compliant. We have both the scientific understanding and regulatory knowledge, to offer both pharmaceutical raw materials and finished product testing services.