Method Development Validation and Transfer

Method Development and Validation studies play a vital role in the success of your products. It is essential to have a highly experienced expert partner on your side. Robust, well-developed analytical methods offer cost-efficiency for the sponsor in the long run by insulating the products from out-of-specification or out-of-trend results during specification testing for release or stability studies. CAL develops analytical methods using scientific principles and the latest technology for the following verticals:

• Active Pharmaceutical Ingredients (APIs)
• Drug Formulations
• Dietary Supplements
• Cosmetics and Personal Care Products
• Industrial Products (household and commercial cleaning products)

Why Expertise and Experience Matters

Analytical methods are required by laboratories to facilitate either qualitative or quantitative analyses of an ingredient to establish the identity, purity, physical characteristics and performance in a mixture or formulation.

Method development and subsequent verification, or validation are often challenging endeavors. This applies particularly with the discovery of new molecules or with complex mixtures where analytical methods do not exist. The development of analytical methods is also constrained by the ability of the method to isolate the analyte of interest from the rest of the formulation.

In these instances, systematic, scientific development activities need to take place that include identification of an appropriate technology; a review of the impact of other constituents in the formulation that may interfere with the analysis; and conditions that need to be optimized based on the physical and chemical properties of the analyte of interest.

We have on-site experts in several scientific disciplines such as organic chemistry, analytical chemistry, biochemistry, and microbiology and with that a wide scope of knowledge and depth of understanding the nature of molecules and formulations. This level of expertise and experience coupled with the latest technology allows us to develop methods scientifically and efficiently and that are fit for purpose and can be quickly validated.

We bring a unique expertise where official methods do not always work such as with multi-ingredient formulations that are compounded into very complex matrices of botanicals.  We have successfully developed robust analytical methods for a wide range of applications that range from environmental chemicals to pharmaceuticals, dietary supplements and foods.

We are highly skilled at recognizing and understanding specific requirements and solving unique problems as products transition from Research and & Development to Production.

Method validation confirms that the method is specific, precise, accurate and robust. Our expertise with validation ensures your confidence in the results and the method is fit-for-purpose and accurately quantified for your specific compound and apply at any stage of discovery, development, and manufacturing. Our team ensures that all work is carefully planned, performed and documented at all stages to ensure that due process is followed.

For Identification and quantification of:

• Excipients
• Intermediates
• Raw materials
• Preservatives
• Antioxidants
• Impurities

Methods are validated according to:

• ICH Harmonized Tripartite Guideline Validation of Analytical Procedures: Text and Methodology Q2(R1) November
• World Health Organization (WHO), Guidelines on Validation – Appendix 4 Analytical Method Validation, September 2018
• USP-NF <1224> Transfer of Analytical Procedures
• USP-NF <1225> Validation of Compendial Procedures
• USP-NF <1226> Verification of Compendial Procedures

• Bio-analytical assays
• Identification
• Assay testing
• Testing for impurities
• Stability indicating methods
• Light stressing
• Microbial testing
• Particle size analysis

Validation studies include determination of: 

• Specificity and Selectivity
• Precision (Repeatability, intermediate precision, and reproducibility)
• Linearity
• Accuracy & Recovery
• Solutions Stability
• Limit of Detection (LOD)*
• Limit of Quantitation (LOQ)*
• Range
• Robustness
• Forced Degradation Studies (Acid, Alkali, Oxidation, Thermal, Photostability, UV/Direct Light)
• System suitability
• Filter retention study
• Linearity

*Also applies for residual solvents and impurities methods

We perform technological transfers of existing methods from other laboratories and provide verification of Pharmacopoeias.

We employ the latest technology to develop analytical methodology. The instrumentation employed is selected based on the initial analysis of the molecule of interest and the matrix in which it resides in formulation. We maintain a very active capital investment strategy to ensure a broad range of instrumentation is available for their R&D department to efficiently develop and validate analytical methods.