Pharmaceutical Excipient Analysis, Quantification and Characterization
Specialized Pharmaceutical Excipient Analysis Beyond Routine Pharmacopoeial Testing
Excipia is a specialized pharmaceutical excipient analysis and characterization laboratory providing quantitative, chemical and physicochemical characterization of excipients as raw materials and in finished drug products.
We help pharmaceutical companies investigate questions that cannot always be answered by routine pharmacopoeial testing: How much of an excipient is present? Are nominally equivalent grades, batches or suppliers really comparable? Which excipient characteristics may influence formulation performance? Could reactive components contribute to API degradation or stability problems?
Our scientists develop targeted analytical approaches for excipient quantification, grade and supplier comparison, excipient variability, functionality-related characteristics, reactive impurities and formulation troubleshooting. More than 25 years of pharmaceutical formulation-development experience allows analytical findings to be interpreted in the context of the drug product rather than as isolated laboratory results.
Rather than applying a fixed analytical package, we tailor the characterization strategy to the excipient, formulation and specific pharmaceutical question.
Need an Excipient Analyzed?
Tell us which excipient, formulation or analytical problem you are working on. Our scientists can assess the question and propose a targeted characterization approach.
What Can Excipia Help You Determine?
Excipia supports pharmaceutical development teams with questions such as:
- What excipients are present and in what quantity?
- Are excipient batches, grades or suppliers analytically comparable?
- Which excipient characteristics may influence formulation performance?
- Could reactive components contribute to API degradation or stability problems?
- Which functionality-related characteristics should be controlled?
- Why did product behaviour change after an excipient, grade or supplier change?
The analytical strategy is selected according to the excipient, formulation and pharmaceutical question rather than from a predefined test package.
Excipient Quality & Variability
Compare grades, batches and suppliers and investigate characteristics beyond routine specifications.
Deformulation & Excipient Quantification
Identify and quantify excipients in finished pharmaceutical products, including Q1/Q2 assessment.
Pharmaceutical Reverse Engineering
Understand how formulation composition and product characteristics contribute to reference-product performance.
Excipient & Formulation Troubleshooting
Investigate whether excipient characteristics contribute to stability, dissolution, manufacturing or other product-performance problems.
Excipient Quality, Variability and Reactive Components
Excipient quality cannot always be fully understood from routine pharmacopoeial specifications or a Certificate of Analysis. Materials that meet the same compendial requirements may still differ in molecular characteristics, residual components, reactive impurities, particle properties or other functionality-related attributes.
These differences can become important when comparing suppliers or grades, investigating batch-to-batch variability, qualifying a second source or troubleshooting unexpected formulation, manufacturing or stability behaviour.
Depending on the excipient and pharmaceutical question, Excipia can investigate characteristics such as chemical composition, molecular-weight distribution, degree or distribution of substitution, monomer or carbohydrate composition, degradation products, organic acids, aldehydes, peroxides, reactive functional groups and other material-specific attributes.
The objective is not simply to demonstrate that two excipient materials are analytically different. It is to determine which differences may be relevant to the specific formulation or drug product problem.
Deformulation and Pharmaceutical Reverse Engineering
Excipia can identify and quantify excipients in finished pharmaceutical products to establish what is present and how much is present. Depending on the formulation and excipient, characterization may also provide information about grade, quality or source-related markers.
This deformulation approach can support Q1/Q2 formulation assessment, generic and hybrid drug product development, comparison of test and reference products, and investigation of formulation differences relevant to bioequivalence or product performance.
Pharmaceutical reverse engineering is broader than deformulation. It combines composition data with physical characterization, formulation science and performance testing to understand how and why a product behaves as it does.
Through Avivia, these investigations can be combined with formulation development, dissolution and release testing when analytical differences need to be related to actual drug product performance.
Excipient Characterization for Formulation Troubleshooting
Excipient properties can influence manufacturing behaviour, drug release, stability and overall drug product performance. When a formulation behaves unexpectedly, the relevant material attribute may not be included in routine excipient specifications.
Excipia can support investigations of batch-to-batch variability, excipient grade or supplier changes, functionality-related characteristics and API–excipient interactions. Analytical findings can be interpreted together with formulation and performance data to determine whether an excipient difference is likely to be pharmaceutically relevant.
This approach can support formulation development, root-cause investigations, excipient selection and the definition of product-specific material specifications.
Why Pharmaceutical Companies Use Excipia
Excipia combines specialist excipient knowledge with custom analytical method development and more than 25 years of pharmaceutical formulation experience. We work with excipients both as raw materials and within finished drug products, allowing analytical differences to be interpreted in their pharmaceutical context.
Projects are designed around the problem that needs to be solved rather than around a standard laboratory test package. Where required, characterization can be combined with Avivia’s formulation, analytical and dissolution capabilities to investigate whether identified excipient differences affect drug product performance.
Tell us what you are trying to understand, compare or troubleshoot.
Frequently Asked Questions About Excipient Analysis and Characterization
Can Excipia quantify excipients in finished pharmaceutical products?
Yes. Depending on the formulation and excipient, Excipia can develop selective analytical methods to identify and quantify excipients in finished drug products. These data can support deformulation, Q1/Q2 assessment and comparative formulation characterization.
Can Excipia compare excipients from different suppliers?
Yes. Excipient batches, grades and suppliers can be compared using chemical, molecular and physicochemical characteristics selected according to the material and its intended function in the drug product.
Can Excipia investigate reactive impurities in excipients?
Yes. Depending on the excipient and API degradation pathway, targeted analysis can investigate potentially relevant components such as reducing carbohydrates, aldehydes, organic acids, peroxides, degradation products or other reactive species.
Can Excipia develop a custom excipient analysis method?
Yes. Many excipient questions cannot be addressed using standard pharmacopoeial methods. Excipia develops targeted sample-preparation and analytical methods based on the material, formulation and pharmaceutical question.Read More
At Excipia, projects are handled by small multidisciplinary teams with experience in excipient characterization, analytical method development and pharmaceutical formulation. We work directly with clients to understand the scientific question behind the analytical request and design an investigation that generates information relevant to the drug product.
Try us. Feel free to contact us using the form above or by sending a message to Excipia@avivia.nl.
Menno Wiltink,
Founder of Excipia.
Examples of Excipients and Related Components We Have Experience With
Polysaccharides
– Cellulose
– Starch
– Alginate
– Xanthan gum
– Carrageenan
– Pullulan
– Chitosan
…..
Cellulose derivatives
– Microcrystalline cellulose MCC
– Hydroxyethyl cellulose HEC
– Hydroxymethyl cellulose HMC
– Hydroxypropyl methyl cellulose HPMC
– Hydroxypropyl cellulose HPC
– Methyl cellulose MC
– Ethyl cellulose EC
– Carboxymethyl cellulose CMC
– Hydroxyethylmethyl cellulose HEMC
– Hydroxypropyl methyl cellulose acetate succinate HPMCAS
Polyols
– Glucose
– Galactose
– Fructose
– Mannitol
– Sorbitol
– Xylitol
– Lactose
– Sucrose
– Maltitol
Other excipients
– Polyethylene glycol PEG
– Polysorbate
– Citric acid
– Magnesium stearate
– Polyoxyl castor oil
– Polyvinylpyrrolidone PVP
– Poloxamer
– Mint
– Silica
– Talc
Related substances
– Furans
– Aldehydes
– Organic acids
– Peroxides
– Hemicellulose
– Solvents
– Monomers
– Lignin
