API Analysis

API Analysis

A comprehensive study of the active ingredients’ physical and chemical characteristics plays a central role in the early stage of drug development. Some determinant attributes of API state the following development strategy: the solubility and permeability are very important for determining whether the drug is to be administered, for example, i.v. or orally. Besides, the molecular structure is one of the representative factors that have a pivotal effect on the selection of excipients.

Below is a list of our API Analysis Services (including but not limit following):

Solubility analysis represents the process of determining the dissolution profile of a compound in a given volume of solvent. Determination of the solubility for drug substances have a significant effect on bio/pharmaceutical development and is favorable for preliminary understanding of the pharmacodynamic properties. At BOC Sciences, you can be provided with:

  • pH solubility profile
  • Solubility in simulated intestinal fluid and gastric fluid
  • Solubility improvement

Stability investigations include studies on ICH photo stability, acid/alkali stability, humidity stability, thermal stability, solution stability, solid state stability, accelerated experiment, and long-term stability. Stability studies have a critical effect on pharmaceutical development since it provides the essential data that illustrate how the environmental factors such as temperature, humidity, and photo stability influence the quality of drug products.

Although the morphology, solvates and particle size-distribution are considered to be the important properties for an active pharmaceutical ingredients, polymorphs, the uncontrolled occurrence of multiple physical forms, can signally influence the performance of drugs in many ways such as stability, solubility and the pharmacological activity.

The hygroscopicity of API is an essential reference factor for choosing appropriate preparation technologies and conditions. For pharmaceutical development, the moisture sorption evaluation is always conducted during the early stages to optimize the formulation parameters, manufacturing process and establish a storage condition for the drug substances or end products.

The permeability and partition coefficient of API are the decisive factors that affect the in vivo absorption and distribution of drug molecules. Majority of drug failures are mainly ascribed to the unfavorable pharmacokinetic, ADME properties, toxicity and adverse side effects that are closely related to the undesirable permeability/partition coefficient properties of drug substances.

To improve the bioavailability of poorly soluble active ingredients, preparing it to the salt form represents an effective strategy. Besides, micronization of drugs by air slide disintegrating mill or ball grinder can also significantly improve the solubility of drugs in water.

A profound understanding of the mechanical properties of powder helps to decide which processing method to use, for example, direct compression or granulation, should be applied to improve poor blend compressibility.

We have expertise in analyzing the common physicochemical properties of compounds (logS, logP, logD, pKa). As they are typically done in the very early stages of drug discovery, it’s better to analyze a set of compounds rather than individual compound. In addition to the above properties study, we also offer test and research services including:

  • Molecular Structure Analysis
  • Particle Size, Shape & Surface Area
  • pKa Measurement

We routinely conduct API analysis on weekly basis. Depending on our customer’s needs, we can do both the full reporting of the study or just analyzing the selected properties and reporting them in a spreadsheet format. Equipped with advanced analytical instruments, BOC Sciences can provides a comprehensive physicochemical characteristics of drug candidates to guide the next formulation development.

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