Active pharmaceutical ingredient characteristics

Some of the physicochemical properties of the active pharmaceutical ingredient (API) that influence the dissolution characteristics are ... 

For pharmaceutical scientists, the value in cocrystals would be if such materials would be superior active pharmaceutical ingredients relative to the drug substance itself. This possibility has been studied for the carbamazepine-saccharin cocrystal, where its performance characteristics were compared with the marketed form of carbamazepine [46]. It was learned that the physical and chemical stability of formulations containing the carbamazepine-saccharin cocrystal product were similar to those of carbamazepine in the marketed product, and comparative bioavailability studies demonstrated that the cocrystal was a viable alternative drug substance to the anhydrous drug form used in the conventional solid dose forms. 

By the time an active pharmaceutical ingredient (API) is made available to an analytical chemist in the formulation development group, most or all of the physical characteristics of an API has already been studied and the information should be available in some sort of a report from the drug substance group or preformulation group. Some of the key parameters that an analytical chemist in formulation development requires from such a report are the solubility and solution stability. 

A comparison of International Conference on Harmonization (ICH) guidelines on allowable concentrations of solvents in active pharmaceutical ingredients against EHS characteristics of solvents ... 

Eligibility for the biowaiver procedure based on solubility and permeability characteristics of the active pharmaceutical ingredient... 

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 ... 

It is stated that nasal sprays have unique characteristics with respect to formulation, container closure system, manufacturing, in-process and final controls and stability. The product must deliver reproducible doses during the whole life of the product. Excipient controls are discussed in the FDA draft guidance in many respects, the chemistry, manufacturing and controls (CMC) standards expected of excipients are starting to approach those required of the active pharmaceutical ingredient (API). 

Quality control Measures designed to ensure the output of batches of active pharmaceutical ingredients conforming to established specifications of identity, strength, purity and other characteristics. 

Specification Established requirements for a raw material, packaging material, intermediate product, or active pharmaceutical ingredient in terms of its physical, chemical and (possibly) biological characteristics. 

The test identifies the substance to be examined as a salt of potassium, K+. As with other alkali metals, potassium is exclusively found as the monovalent cation. Since almost all salts of potassium are water soluble and it is a very inert ion, as a rule these do not contribute to the characteristics of its salt. For this reason its function in the compounds enrolled in the pharmacopoeia is to be an indifferent counter-ion, both for simple inorganic anions but also for anionic active pharmaceutical ingredients. Reference to potassium is made in about twenty-five monographs. In about half of them test (b) is dictated in about one-quarter and in the last quarter both tests have to be performed. The anions in the organic salts are, with the exception of Acesulfame, carboxylic acids. Due to the high water solubility of potassium, sample preparation is in most cases just a simple dilution in water. 

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