Physicochemical property and their evaluation are integral steps in the manufacturing process. It is essential for product verification, manufacturing support, and several other programs for pharmaceuticals and biologics. Across the globe, one can find the essential guidelines that define the necessity of physiochemical testing. Both physical and chemical properties matter significantly and they should not vary between or within the production lots. Why? Because these determine the critical compound features including drug delivery and absorption of the product. One needs to ensure an effective solution for testing with best-in-class facilities. Finding a comprehensive package for testing services will suit the customized requirements of physicochemical testing. Get end-to-end testing solution for – moisture content, osmolality, viscosity, appearance, pH, optical activity, and spectral analysis.
Various testing aspects – Know them rightly
- The appearance of the product – The norms related to Visible Particulates in Injections eases the requirements for all products intended for parenteral administration. Industrial approval is necessary and it is possible only with testing drills. The products must be visually inspected. The test report validates if the products are free of visible particulates. These extraneous undissolved particles may indicate external contamination, sterility issues, etc. The results determine the effectiveness of the produced lot. One must monitor the particulate matter and incorporate the appropriate controls.
- pH Factor – The top labs provide efficient and accurate testing for pH factors and help you meet the norms and guidelines. One can determine if the sample is acidic or alkaline, meeting the client’s specifications. The pH factor of a sampled molecule in a pharmaceutical or biological formulation can impact its stability, solubility, etc.
- Moisture and humidity – The top-notch lab facilities and their dedicated staff ensure an accurate report on moisture content testing. In many cases, the water content gets determined via the Karl Fischer titration method, a globally-approved industry standard. Various pharmaceutical and biological products may contain water as hydrates or water of crystallization. It may also be in an adsorbed form of surface water. The percentage and degree of water can impact the shelf life, effectiveness, and quality. Thus, one must ensure compliance to meet the specifications.
- The osmolality factor – Osmolality is an integral factor, and you cannot ignore it for a developed drug. The factor is defined as the total number of solute particles present in a kilogram of solvent. Osmolality and Osmolarity get determined with the freezing point technology and provide the correct isotonicity, consistency, and formulation of the stable product.
- Fluid viscosity – Viscosity is a fluid’s resistance to flow. The measured viscosity in the fluid product is a vital component in production effectiveness. The top labs provide robust viscosity testing solutions with modern rotational methods. Viscosity is critical in a formulation and determines the intended utility and activity, exhibiting a benchmark for compound concentration or degradation.
- Optical effects – Several pharma compounds are optically active. The molecules can get influenced by light and move with the plane-polarized light. The Optical Rotation measurements make a difference in the effectiveness of the testing results. One can review the polarimetry for therapeutic products like antibiotics, dextrose, and steroids. The measure of optical activity in the solution determines the effectiveness of the product lot. One can obtain predetermined target specifications that are globally popular. Polarimetry helps detect impurities or determine the concentration of the sample chiral drug product.
- The spectral analysis – The distinct absorption spectra of chemical and biochemical products can help detect the distinctive physicochemical property for a specific pharmaceutical product. The top labs utilize Ultraviolet-Visible rays and Fourier Transform Infrared Spectroscopy for sample identification and concentration measurement. The techniques of spectral analysis are vital to reveal impurities in the sample product.
Physicochemical testing for the pharmacy industry
Researchers require various documents that inform about the particle size with drug performance. It is vital for determining rates of absorption, dissolution, and content uniformity. One of the prime advantages of pharmaceutical particle size testing is to facilitate the production process of pharmaceutical companies. They can manufacture better and formulate dosage forms appropriately. The distinct approaches and techniques like Laser Diffraction Measurement offer reliable testing solutions, depending on the product formulation. Through intensive research and evaluation of the particle size, during various stages of drug development and manufacturing, one can develop safe, efficient, and stable products. It gets easy to control contaminating particles and eliminate them, enhancing the drug performance as intended.
Benefit – Quality improvement
The particle size of the product developed by pharmaceutical manufacturers has an intense impact on the physical and chemical effects. Thus, the size is significant for the product features, emulsions, powders, creams, liquids, etc. It is vital to review the following –
- Adhesive strength
- Thermal conductivity
- Drying properties
Particle size testing is critical for any company trying new drug delivery formats like nanoparticles and liposomes. It is an indispensable step during stability testing without which a company cannot release the drug to the market. Every pharmaceutical company needs to ensure consistency with particle size and properties.
Benefits at a glance – Zero contamination and effectiveness
- Testing the size of drug particles reviews the chances of contamination. The test reports can assist a company to make better decisions and install measures to monitor the contaminating particles.
- Drugs with particle contamination react adversely on a user’s body. These particles of varied sizes can physically block the blood flow in multiple organs. Thus, it is critical to check the particle size, eliminating the safety concerns.
- Particle contamination can also impact the user’s immune system. The human body can identify the particles as foreign components, making them less impactful for the body.
Thus, it is paramount for pharmaceutical companies to employ various techniques available for reviewing the particle size of the high-quality product and ensuring the best output.
Trust the expert testing facilities at the top lab.
Get a top-notch testing solution with IRCLASS Systems and Solutions Pvt Ltd (ISSPL) and ensure a hassle-free service for quality checks and more. The reliable lab-testing setup brings everything you need for product checks. Ease the requirements with an efficient solution from the ISSPL lab.