Method Development

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Method Development

The method of purity studies, impurities identification and characterization, stability studies are important step in drug development, these methods mentioned above are widely used in quantitative and qualitative analysis of drugs. The mastery of these skills determines whether the drug is being developed smoothly, and even how much time and experience it takes. It's a problem that more and more drug companies have to solve. Of course, it is a challenging work for the development team to identify the impurities formed in very small quantities in a drug substance. Since mostly it is difficult to identify and control impurities in the drug synthesis.

Below is a list of our method development services (include but not limited to the following):

Purity studies is a method that depends on properties and chemical reaction to analyze the purity of substance, the presence of impurities in drug substance is extremely critical issue and can have a significant impact on the quality and safety of drug. The International Conference of Harmonization (ICH) guidelines indicate that unknown impurities at or above 0.10% in the drug substance depending on the maximum daily dosage, should be characterized. It is the most concerning task in modern pharmaceutical analysis to manufacture high quality drug. Analytical methods such as High performance liquid chromatography (HPLC), Liquid chromatography–mass spectrophotometry (LC–MS), Column chromatography and Nuclear magnetic resonance spectroscopy (NMR) are commonly used in laboratories for the qualitative and quantitative analysis of drug.

As per the general guidelines required by the International Conference on Harmonisation (ICH) to qualify the drug substance, the amount of acceptable level for a known and unknown related compound (impurity) should be less than 0.10%, respectively. In order to meet the stringent regulatory requirements, impurities should be identified and their amounts should be controlled strictly. Most of the impurities are not commercially available and they should be synthesized by the development team, which is not so easy since their syntheses are not known or not described before. We believe that development of a drug substance is incomplete without the identification of an impurity profile involved in the process. Thus, the study that contain formation, identification, synthesis and characterization of impurities will be of immense help for pharmaceutical development teams.

The purpose of stability is to provide evidence on how the quality of a drug substance varies with time under the influence of a variety of environmental factors, such as temperature, light, and humidity, and to establish a retest period for the drug substance and recommended storage conditions.

Organic volatile impurities (OVIs), generally represent the chemical compounds in products, and are mainly produced by incomplete removal of the residual solvent during the manufacturing of active pharmaceutical ingredients (APIs), excipients and drug products. Recognizing the fact that these OVIs have an obvious adverse effect on the quality, safety, stability, potency and other performance of the finish products or intermediates, complete or partial removal of a solvent or solvents is therefore a pivotal stage in many pharmaceutical processes.

Cleaning verification represents the procedure of verifying whether the manufacturing equipment is maintained as clean and uncontaminated to ensure the pharmaceutical products are produced without risk of residual unwanted substances. Those potential contaminants mainly include residues of the active pharmaceutical ingredients, degradation of certain compounds and even the detergents or solvents generated during the cleaning process. In this case, cleaning verification is an effective tool that can ensure that the process and processing equipment are suitable for manufacturing, prevent drug contamination and improve drug quality.

BOC Sciences is proud to provide you high-quality method development services. We can provide rapid, reliable, safe and clean method in drug detection, component analysis, impurities identification that produced in the process of drug synthesis, even if that is tiny amounts of a substance.

Reference:

  1. Bellur, E. A., & Karlığa, B. (2015). Identification, synthesis and characterization of process related impurities of benidipine hydrochloride, stress-testing/stability studies and HPLC/UPLC method validations. Journal of pharmaceutical analysis, 5(4), 256-268.
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