Answers to Your Analytical Questions.

Analytical method development is the process of designing a laboratory procedure — such as an HPLC method — that can reliably measure a specific attribute of a product, for example the content of an active ingredient or the level of an impurity. It involves selecting suitable instrumentation, columns, mobile phases, sample preparation and system suitability requirements, then optimising those conditions until the method performs consistently for its intended purpose.

Typical analytical testing includes assay and potency determination, related substances and impurity testing, identification testing, pH, physical characterisation and stability testing. The exact tests depend on the product, dosage form and the question being asked; we define the scope with you before work begins.

Method performance evaluation examines characteristics such as specificity, linearity, range, accuracy, precision, detection and quantitation capability, robustness and solution stability. These characteristics are assessed against predefined acceptance criteria aligned with the intended use of the method and applicable ICH expectations.

Yes. Methods are developed around the product’s formulation, active ingredient, excipients and the intended analytical purpose, rather than using a generic approach. Product-specific development helps ensure the method distinguishes the analyte from other formulation components and degradation products.

Impurity profiling is the systematic detection, monitoring and characterisation of impurities associated with a pharmaceutical substance or product. This can include process impurities, degradation products, related substances and previously unknown peaks observed during analysis.

Degradation (forced degradation or stress) studies help identify how a product responds to conditions such as acid, base, oxidation, heat, humidity and light. The results inform the development of stability-indicating methods, help identify likely degradation pathways and support quality risk assessments.

Depending on the product, stress conditions can include acidic and basic hydrolysis, oxidative stress, thermal stress, humidity exposure and photolytic (light) exposure. Conditions are selected to be scientifically meaningful for the formulation and intended study objective.

Yes. Impurity and degradation data can contribute to out-of-specification investigations, deviation assessments, quality risk assessments and lifecycle monitoring by helping explain what has changed in a product and why.

Rapid-turnaround analytical support is a prioritised testing service for time-sensitive situations such as investigations, deviations, unexpected results or urgent regulatory requests. The analytical scope is kept focused on the specific question so results can be generated in an accelerated timeframe while maintaining appropriate quality controls.

Urgent testing commonly includes assay and potency, impurity and related-substance testing, identification testing and comparative testing against reference or historical data. The exact scope is agreed with you based on the question, sample availability and timelines.

Yes. Targeted testing and structured data review can provide additional analytical evidence to support assessment of out-of-specification (OOS) or out-of-trend (OOT) results and help identify potential contributors to the observed event.

Custom formulation development is the design and optimisation of a product formulation around specific requirements — for example a particular dosage form, strength, route of administration or manufacturing environment. It covers ingredient selection, excipient compatibility, composition design, processing considerations and performance evaluation.

Yes. Development can support oral solid and liquid forms, solutions, suspensions, creams, gels and other topical forms, as well as sterile and non-sterile preparations, subject to the technical requirements of each dosage form.

Excipient selection considers functionality (for example solubilisation, viscosity, preservation or buffering), compatibility with the active ingredient and other components, regulatory acceptability for the route of administration, and the impact on stability, processing and product performance.

Formulation strategies can be designed with scalability in mind, considering processing practicality, reproducibility and manufacturing requirements so that a formulation developed at small scale can be translated to batch production where applicable.

Recipe creation produces a complete compounding procedure: the quantity and role of each ingredient, the order of addition, mixing conditions, temperature and processing parameters, and packaging or handling considerations needed to prepare the formulation consistently.

Yes. Processing parameters such as mixing sequence, mixing time, temperature control and addition order are defined because they can materially affect uniformity, stability and reproducibility of the finished preparation.

Incompatible excipients can cause precipitation, phase separation, pH shifts, degradation of the active ingredient or changes in viscosity and appearance. Assessing compatibility early reduces the risk of formulation failures during preparation or storage.

A stability-supported formulation package pairs formulation development with structured stability evaluation — accelerated and long-term studies, degradation analysis and packaging/storage assessment — so that formulation decisions are backed by analytical evidence of how the product performs over time.

Accelerated stability studies expose the product to elevated temperature and/or humidity for a shorter period to identify potential stability concerns quickly. Long-term stability studies monitor the product under its intended storage conditions over an extended period and are the primary basis for storage and dating decisions.

Yes. Monitoring assay, impurities and physical attributes over time, together with stress-study data, helps identify which degradation mechanisms affect the formulation and which formulation, packaging or storage factors influence them.

Stability data can support beyond-use date (BUD) or expiry dating considerations when the study design, analytical methods and acceptance criteria are appropriate and applicable standards are followed. We organise and interpret the stability evidence; the final dating decision remains with the responsible quality function.

Common issues include precipitation or crystallisation, phase separation, potency drift, pH instability, viscosity changes, poor uniformity and processing inconsistencies.

We review the composition, product history, processing conditions and analytical data, then evaluate the formulation attributes most likely to contribute to the issue — for example solubility, compatibility, buffering or process parameters — before testing targeted changes.

Yes. pH and viscosity are often linked through excipient behaviour and ingredient interactions, so they can be evaluated within the same troubleshooting investigation.

Targeted reformulation changes — to excipients, concentrations, pH or processing — are tested and the revised formulation is evaluated to confirm improved performance before recommendations are finalised.

Batch consistency testing compares analytical results for critical quality attributes across multiple manufacturing batches to evaluate whether the process repeatedly produces product meeting its requirements.

Commonly compared attributes include assay and potency, impurities and degradation products, pH, physical characteristics and other product-specific critical quality attributes defined in the specification.

Process verification uses analytical data from representative batches to demonstrate that a manufacturing process consistently produces product meeting predefined quality requirements.

Yes. Trend and variability analysis across batches can reveal relationships between raw materials, process parameters, in-process attributes and finished-product quality, supporting process understanding and investigation.

Analytical batch data can form part of the evidence used in process validation and continued process verification programs, alongside the manufacturer’s own process and quality documentation.