Active pharmaceutical ingredients component

Most drugs that are prescribed to us are formulated with active pharmaceutical ingredients and excipients. The formulations of selected drugs are presented in Exhibit 5.11. According to the US Pharmacopoeia and National Formulary definition, excipients are any component, other than the active substance(s), intentionally added to the formulation of a dosage form. There are many reasons for the addition of excipients ... 

Preformulation profde or characterization of the components of the formula, which includes all the basic physical or chemical information about the active pharmaceutical ingredients (API, or the chemical entity) and excipients... 

In Section 8.2, the aim of analysis is emphasized especially for the API (active pharmaceutical ingredient) and the drug product. The workflows and the rationale at major decision points during synthetic processing steps where HPLC can be applied in process development are elaborated upon. For example, a fast method is needed to monitor reaction conversion of two components. However, a more complex method would be needed for stability-indicating purposes where multiple degradation products, synthetic by-products, and excipient peaks need to be resolved from the active pharmaceutical ingredient. 

Change in a critical component (usually refers to active pharmaceutical ingredient, key excipients, or primary packaging) ... 

Drug substance-. The drug substance (DS), also known as a new chemical entity (NCE) or the active pharmaceutical ingredient (API), in early phases of drug development consists of the following components (a) active moiety, (b) counter-ion, and (c) water or solvent molecules that are known components of the DS crystal structure. If the single crystal structure of the DS is unavailable, the DS can be defined as a hydrate or solvate based on the results of other analytical tests and the scientific judgment of the scientist. 

Analytical method goals are often defined as method acceptance criteria for peak resolution, precision, specificity, and sensitivity. For instance, pharmaceutical methods for potency assays of an active pharmaceutical ingredient (API) typically require the following resolution >1.5 from the closest eluting components precision of retention time and peak area, <1-2% RSD and linearity in the range of 50-150% of the label claim. Other desirable characteristics include ... 

Typical tests performed on raw materials, including the active pharmaceutical ingredient, excipients and packaging components, are as follows ... 

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