Pharmaceutical Testing Laboratories
In our lab, pharmaceutical pharmaceuticals are created using a strictly regulated procedure to guarantee that the substance, drug product, or formulation complies with health and safety requirements. Pharmaceutical testing facilities offer analytical services that are utilised in the preparation of medicinal products for scale-up manufacture and clinical trials. In accordance with CGMP manufacturing regulations, our Research Institute offers completely compliant facilities to enable the testing, characterization, and release of pharmaceutical products. See more about the Institute's Pharmaceutical Development division and our CGMP Manufacturing services.
PHARMACEUTICAL ANALYSIS LABORATORY SERVICES
To support the evaluation, characterization, and distribution of pharmaceutical products in accordance with generally accepted chemical analysis practises, we have pharmaceutical analysis facilities that are fully compliant. Our pharmaceutical testing laboratory services serve a wide range of pharmaceutical formulations, including novel chemical entities (NCEs) and products with microencapsulation (taste masking, tamper resistant, and controlled release). We provide support to scientists working in the following labs, among others, along the entire drug development supply chain:
We will develop and validate methods needed for your drug product / dosage form to include in your CMC section to include:
Assay and Impurity Test
Chemical purity is determined by the assay and impurity test. To comply with the limits outlined in USP, EMA, and other regulatory guidances, impurities contained in a drug substance or drug product need to be closely checked. These contaminants are either degradants that can accumulate over time or process impurities. To track observed and potential contaminants, reliable procedures must be created and tested. Impurities must be monitored, reported, detected, and classified according to level when they reach a particular threshold.
HPLC Drug Testing
The high performance liquid chromatograph, or HPLC drug testing, is a stability indicating method used to measure the active ingredients in a drug substance or drug product.We uses HPLC test equipment to perform for assay and impurity testing.
Residual Solvent Analysis
We use gas chromatography to analyse residual solvents. An essential stage in CGMP manufacturing is monitoring and regulating contaminants, such as solvents left over following API synthesis. The method of analysis and quantification preferred by the industry is head space gas chromatography carried out in accordance with United States Pharmacopeial Convention (USP) Chapter 467 (organic volatile contaminants). Remaining solvents in the API or dosage form are regarded as contaminants, and their quantities must be regulated to within set industry standards. We will validate the gas chromatography method for use in release testing after method development.
Drug Dissolution Testing
Drug dissolution testing is required to ensure a drug product functions as intended once it enters the body. We performs in vitro dissolution and drug release testing in accordance with USP Apparatus 1 (basket), USP Apparatus 2 (paddle) and USP Apparatus 4 (SOTAX). Dissolution testing is often performed to evaluate performance of enteric coatings, or polymers used to coat oral tablets. An enteric coating must resist acid conditions in the stomach but release in the neutral environment in the lower gastrointestinal track. Additionally, controlled or extended release formations need methods developed to asses burst release and depletion of the active over time.
ICH Stability Studies
ICH stability studies offer recommendations on testing drug goods for storage under various conditions and aid in determining an expiry. Controlled stability experiments are carried out simulating different climatic regions around the world. These studies may potentially hasten the breakdown of the drug or formulation, which must be watched to preserve a sufficient supply of usable medications. The drug material and drug product are kept in stability chambers with exact humidity and temperature controls.
Particle Size Analysis
The bioavailability and solubility of a pharmacological ingredient or product might be affected by its size. Particle size is used in controlled release applications to forecast how substances will be released into the body. We are able to support particle size analysis in the sub-1 nm to micron range.
TGA and DSC Analysis
We performs thermogravimetric analysis (TGA) and differential scanning calorimetry (DSC). TGA and DSC analysis are chemical tests that determine melting points and moisture in addition to the study of phase transitions such as melting and exothermic decompositions and glass transitions. DSC can be used to characterize crystal structure and polymorphs.
Additional Laboratory Analytical Services
We have a full complement of qualified and calibrated pharmaceutical testing instrumentation to include UPLC (ultra-high performance liquid chromatography), HPLC, GC (gas chromatography), nanoparticle sizing and characterization, and differential scanning calorimetry. Other Services include:
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Zeta potential
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Light degradation
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Impurity identification
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Active pharmaceutical Ingredient (API) and raw material release
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GMP product release
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Primary and secondary reference standard characterization
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GMP NMR analysis
