Pharmaceutical
KELAB Scientific leadership team is well-experienced in pharmaceutical development with many successful drugs approval in global markets such as the US, Europe, Asia, Canada and LATAM.
Our pharma analytical division provides qualitative and quantitative analysis for testing dosage form pharmaceuticals, active pharmaceutical ingredients, and raw materials. We use state of the art analytical techniques to ensure that our lab testing capabilities are robust, accurate and precise. We validate methods to the highest standards, following internationally recognized guidelines such as ICH, USP, Ph. Eur.
KELAB Pharmaceutical testing procedures are compliant with international regulations such as FDA, ICH.
The regulatory compliance requirements of pharmaceutical products are complex and stringent, requiring solid quality control and quality assurance processes to guarantee that products are fit for the commercial market. To achieve this, we employ globally recognized and validated LIMS and QMS systems to ensure product traceability, testing and control.
Service Highlights
These are critical studies performed to ensure that your chromatographic method is stability indicating. They are part of an overall method development and validation program and consist of stressing samples under basic, acidic, oxidizing and thermal conditions.
Stability studies are required for clinical and commercial products and active pharmaceutical ingredients. They are critical for understanding the stability of your product. We follow ICH Q1A and Q1B for the design and monitoring of product stability. We have stability chambers suitable for climatic zones II, IVA, IVB and accelerated conditions (40 C/75%RH)
A stability indicating method is the cornerstone of your stability program. Health authorities want evidence that methods are suitable for assessing product purity throughout shelf-life or retest period. We develop and validate stability indicting methods using stress samples generated from forced degradation studies and ensure that your method is suitable for quantifying both impurities and known degradation products.
Dissolution testing is a requirement for all solid oral dosage forms and is used in all phases of development for product release and stability testing. With both baskets and paddle apparatus available, KELAB can either execute on an existing disso method or develop a method that can highlight or discriminate product performance.
Potency assays are usually required by regulatory agencies for release of drug product or for quality control of active pharmaceutical ingredients. Chromatographic methods (HPLC, GC) are typically used for assessment, however titration methods can also be employed depending on the material to be tested. Our scientists can develop a potency/assay method or transfer in an use and existing client method
Our scientists develop phase appropriate methods (clinical and commercial products) specific to your product and we strive for simple, robust, operationally friendly techniques to reduce QC time and costs. We are experts in chromatographic separation science and use column screening and dry-lab techniques to quickly develop methods.
We follow ICH Q3D for determination of elemental impurities. We employ ICP-MS and are able to quantitate up to 40 common metals. We offer a validated generic ICP-MS method. which allows us to quickly establish suitability with your product.
We follow ICH Q3C for determination of residual solvents. We offer a validated, generic GC-HS method capable of detecting 28 standard solvents. This allows us to quickly establish suitability with your product.
We conduct validation of method parameters, including selectivity, accuracy, precision, linearity, range, LOQ/LOD and robustness. We develop protocols that ensure your studies are conducted in compliance with ICH Q2B and we issue reports which are suitable for regulatory submissions.
Lot Release & Monograph Testing
KELAB offers a full range of analytical services to support quality control and release testing to ensure the safety and efficacy of your product. For compendia products, we offer USP, EP and INVIMA monograph testing.
We follow cGMP practices to ensure that the testing we perform will be acceptable to FDA, EMEA, INVIMA and other regulatory authorities. We can design a Lot Release Program to meet your testing needs.
Core Analytical Testing Equipment
Mass Spectrometry (LC/MS/MS, ICPMS, headspace GCMS)
Chromatography (HPLC, conventional and UPLC)
Bench Chemistry (titrations, pH measurement)
Dissolution Bath (apparatus 1 and 2)
Short List of the Regulations We Work With
- USP 1224 Method Transfers
- USP 1225 Validation Of Compendial Procedures
- USP 1226 rification Of Compendial Procedure
- USP 232 Elemental Impurity Limits
- USP 233 Elemental Impurity Procedures
- FDA Guidance: Analytical Procedures and Validation for Drugs & Biologics
- ICH Q2 Validation of Analytical Procedures
- ICH Q3A Impurities in Drug Substances
- ICH Q3B Impurities in Drug Products
- ICH Q3D Elemental Impurities
- ICH Q1A Stability of Drug Substance and Drug Products
- ICH Q1B Photo-stability Studies
- ICH Q1E Stability Data
- ICH Q3C Residual Solvents