Alfa Chemistry is a globally oriented generic consistency evaluation services company, providing specialized pharmacological and bioequivalence study services. At the pre-prescription stage, our company provides comprehensive reverse engineering studies of RLD from all perspectives to provide quality targets for subsequent generic drug development.
Our Services
Our physical and chemical properties research services include the following indicators in addition to API & Excipient Crystal Form Study, API & Excipient Particle Size Study, API pKa Study, API & Excipient Solubility Study, and Lipophilicity Study.
Examine the appearance of the RLD. For tablets, the color (and the color of the tablet core after removal of the coating), shape, and the presence or absence of imprints or engravings on the surface are needed to be examined. For capsules, the color and shape of the contents should be observed. For injection, liquid form is an important indicator.
Clarity check is used to check the degree of clarification of a solution by comparing the RLD with a prescribed turbidity standard solution. For checking RLD clarity, we mainly employ a visual method procedure that complies with regulations. If the difference in clarity between the sample and the standard turbidimetric solution cannot be accurately determined by visual inspection, we will use the turbidimeter method to measure and judge the results.
pH is an item necessary for injections. Other liquid preparations, such as oral solutions, should also be checked for pH. We measure RLD pH by using an acidimeter.
Relative density refers to the ratio of RLD density to water density under specified temperature and pressure conditions. Our company generally uses the specific gravity bottle method to determine liquid RLD relative density. For the determination of the relative density of volatile liquids, a Wechsler specific gravity scale can be used.
The phenomenon of solvent diffusion through a semi-permeable membrane from a low concentration to a high concentration solution is called osmosis. The pressure exerted to prevent osmosis is called osmotic pressure. For injections and ophthalmic liquid preparations, the osmotic pressure must be measured. Our company utilizes the freezing point method prescribed by national pharmacopoeias to test RLD osmotic pressure.
Viscosity is the ability of a fluid to resist flow. Determination of the viscosity of a pharmaceutical solution can distinguish or check its purity. Our company uses rotary viscometers for non-Newtonian fluids to measure RLD viscosity.
Visible foreign objects refer to insoluble substances present in preparations such as injections and ophthalmic liquids that can be observed visually under specified conditions. We use the lamp test method to detect visible foreign objects in RLD. The light scattering method can also be used if the sample is packaged in a dark transparent container or if the liquid is dark in color.
Insoluble particles detection refers to checking the size and number of insoluble particles in injections for intravenous use (solution-based injections, sterile powders for injection, concentrated solutions for injection). We perform this test using photoresist and microscopic methods.
Zeta potential has become an important indicator of the surface charge density of particles in solution, and is an essential guide for the study of the stability of emulsions, gels, suspensions and other systems.
When plane-polarized light passes through a liquid containing certain optically active compounds, it can cause the phenomenon of spinning, causing the plane of polarized light to rotate to the left or right. The number of rotational degrees is called rotational luminosity. Rotational luminosity can be used to identify or check the degree of purity of optically active drugs in RLD, and can also be used to determine the content of optically active drugs.
Our physical and chemical testing services are not only applicable to the reverse analysis of RLD, but also to the testing of generic drugs. As well as the testing of samples during an influencing factor examination or storage process.
