pharmaceutical raw material Articles
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Testing of Pharmaceutical & Cosmetic Raw Materials & Final Product Formulations for CODEX, USP/NF & BP Regulations
There are STANDARD Guidelines used to define the Identification and Purity of compounds used in Pharmaceutical and Cosmetic formulations, as well as the final Products. These protocols are described in great detail in the various Monographs of the United States and British Pharmacopoeias, the National Formulary (USP/NF and BP), the International FAO/WHO Codex (CODEX) and other Regulatory ...
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What Revisions Has U.S. Pharmacopoeia Made to Pharmaceutical Excipients?
Pharmaceutical excipients are natural or synthetic substances formulated together with the active ingredients of the drug, whose purpose is to increase the formulations containing effective active ingredients or endow the active ingredients in the final dosage form with therapeutic effects, such as promoting drug absorption or solubility. Pharmaceutical excipients can also be used in the ...
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A 5-minute Screening Method for Incoming Raw Materials in Pharmaceutical Manufacturing
Normal quality control procedures involve accepting a “lot” of a raw material from a supplier and then performing a series of tests to determine if the material is suitable for use in a manufacturing process. For the drug manufacturing industry, as well as many others, this is both a critical and time-consuming (and occasionally costly) step in the process. If the sample is not ...
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Biopharma PEG Supplies Cholesterol (Plant-Derived) Used As Excipients for Lipid Nanoparticles (LNPs)
Cholesterol, a derivative of cyclopentane polyhydrophenanthrene, is the main steroid compound in mammals. Most of the traditional cholesterol comes from animal brainstem and lanolin, which is of animal origin and has the risk of carrying animal viruses. Biopharma PEG innovatively uses plant sterols as starting materials to prepare plant-derived cholesterol (CAS NO.: 57-88-5) through biological ...
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Key Points of Drug Stability Analysis
The purpose of the stability testing is to investigate how the raw materials or pharmaceutical preparations will change over time under the influence of temperature, humidity, and light, so as to provide a scientific basis for the production, packaging, storage, and transportation conditions of the drug, and to establish the validity period of the drug through the test. In addition to humidity ...
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