High Quality services in pharmaceuitics

Invitro Investigation

Dissolution testing in the In-Vitro method is mandatory for all solid oral dosage forms in pharmaceutical pharmacopoeias. This test must be performed at all stages of product development and stability and is one of the most important indicators for evaluating the quality of solid oral pharmaceutical products. This test is also a key test used to detect physical changes in the active pharmaceutical ingredient (API) and in the formulated product.

Drug dissolution evaluation is also used to evaluate the quality, drug release profile and similarity of developed generic drugs with the original brand name of the drug manufacturer. Similarity testing is performed in two ways: in vivo and in vitro. In vivo, the plasma concentration of the drug is evaluated inside the organism, and in vitro, the dissolution and release profile of the drug is evaluated through the dissolution test, and then the in vivo-in vitro correlation (IVIVC) is evaluated to predict the behavior of the drug in the organism with in vitro data.

In this company, in-vitro studies and evaluation of the similarity of generic drugs with brand drugs are carried out in accordance with ICH, USP protocols, as well as the applicant’s specific protocol.

In the final in vitro study report provided by this company, the results obtained, the test method, the protocol used, the equipment and chemical reagents used, as well as the statistical calculations performed, are clearly described, and all chromatograms, spectra, and other instrumental reports are attached to the final report.

Method Validation

Validation of measurement methods used in the pharmaceutical industry is required in pharmaceutical pharmacopoeias and by pharmaceutical regulators. Validation of a measurement method demonstrates that the data obtained from the measurement are accurate, reliable, reproducible, and suitable for the intended use.

Requirements for the validation of measurement methods used in the pharmaceutical sector are described in the USP Pharmacopoeia and in Bracket 1225, as well as in ICH Q2 (R1).

In the development and validation of analysis methods section in this company, upon customer request, the analysis method is first developed and then the method is validated in accordance with pharmaceutical pharmacopoeias, ICH Q2 (R1) guidelines, the applicant’s specific protocol, or the internal protocol of Arman shimisanj Company.

Some of the performance characteristics of the method that are evaluated in the validation process are as follows:

(Accuracy)
(Repeatability)
(Reproducibility)
(Linearity & Range)
(Limit of Detection) and (Limit of Quantification)
(Robustness)

In addition to the mentioned indicators, it is possible to examine other specific indicators upon request.

In the final report provided by this company, the results obtained, the test method, the protocol used, the equipment and chemical reagents used, as well as the statistical calculations performed, are clearly described, and all chromatograms, spectra, and other device reports are attached to the final report.

We are proud to have provided quality, timely, accurate, and tailored services to a large number of pharmaceutical companies in the country in this field. This is just one of the many specialized services we can provide to our clients in the pharmaceutical field.