Analytical Services

Analytical Services

PharmSky Research provides analytical support throughout the entire life cycle of a product starting from early phase drug development through GMP manufacture, regulatory submission, and post registration analytical testing.

PharmSky offers a comprehensive range of routine and highly specialised analytical services. Our laboratories are equipped with cutting edge equipment and a multi-disciplinary team whose broad analytical experience and expertise ensures that our solutions best meet customer needs and the current regulatory requirements. Working in close collaboration with our clients ensures quality is built-in to their analytical methods as appropriate for each stage of development. We have extensive experience supporting customers with accurate and reliable data for clinical trials and regulatory submission.

Our TGA certified analytical laboratory offers a full range of CMC analytical testing for raw materials, excipients, in-process samples and finished products, including:

Method Development: Our experienced team develops robust analytical methods using a quality by design (QbD) approach as per ICHQ14 to support drug product development at different stages. Methods are evaluated for sensitivity, selectivity, linearity, accuracy, and precision as an essential part of method development. Design and execution of forced degradation studies enables identification of the degradation pathways of drug products and optimisation of their analytical methods to ensure they are stability-indicating.

Method Validation: Validation of analytical methods confirms their suitability for the intended purpose at different stages of product development. Partial validation is performed to support early-stage and clinical development. For later stage development, we conduct full method validation activities in accordance with regulatory guidelines.

Method Verification: PharmSky can perform method verification of compendial methods under the direction of a protocol with verification reports provided as required by the client.

Method Transfer: PharmSky works closely with clients to define the most appropriate approach for an efficient method transfer. Regulatory guidance combined with a risk analysis dictates the type of transfer, with the following transfer options typically considered: comparative testing, co-validation, re-validation and method verification.

Typical analytical methods that we develop and validate include:

  • Assay/potency, impurities (degradation products/related substances for drug substances and drug products) methods
  • Other physicochemical characterisation (e.g.colour, viscosity, density, water content, particulate matter, particle sizing) methods
  • Cleaning methods for manufacturing process development
  • Stability-indicating methods for API and drug product stability monitoring
  • Residual solvents testing methods
  • Comparator product characterisation methods

Based on the dosage, impurities of drug substances and drug products need to be assessed. If greater than the threshold defined in ICH Q3, an impurity must be structurally identified and characterised to ensure the safety and quality of the product.

Identifying unknown impurities can be a complex process that involves a combination of analytical techniques and expertise in chemistry. We undertake the following approaches for impurity isolation and identification:

  • Identification threshold calculation based on daily dosage
  • Isolation from the sample matrix by extraction or separation by semi-preparative HPLC
  • Structural elucidation of the purified material using techniques such as NMR, mass spectrometry and IR spectroscopy

Stability testing provides evidence on how the quality of a drug substance or drug product changes with time under the influence of various environmental factors such as temperature, humidity, and light. PharmSky offers a comprehensive set of stability testing services that comply with ICH requirements, including:

  • GMP stability programs
  • Protocol preparation and program management
  • Stability sample storage and management
  • Stability testing of drug substances and drug products for clinical, registration and surveillance purposes
  • Stability-indicating method development and validation
  • Photostability and stress testing
  • Extractables and leachables testing

Samples are analysed at different time points using appropriate methods to monitor changes in quality attributes such as potency, purity, and degradation products. The results of stability studies inform decisions regarding storage conditions, shelf life, and labelling requirements for pharmaceutical products.

Forced degradation studies are employed to forcibly generate product related impurities under accelerated conditions. PharmSky designs and conducts these studies for the following purposes:
  • To develop/evaluate the stability-indicating nature of analytical methods
  • To determine degradation pathways of drug substances and drug products to support formulation development
  • To identify impurities related to drug substances or excipients
Typical stress conditions include temperature (heat), pH (acid and base), light, oxidation and humidity.
In cases where primary standards are not available through compendial sources, PharmSky can perform full characterisation of a drug substance using validated analytical methods. We work closely with clients to establish quality, purity, storage conditions and re-test dates of reference standard material.
ICH Q3C provides guidance on residual solvents in pharmaceuticals, while regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established limits on the allowable levels of residual solvents in pharmaceutical products to ensure their safety and quality. We offer a full range service for residual solvent testing using direct injection GC, Headspace GC and HPLC approaches, including:
  • Evaluation of solvents that are used in the manufacturing of a drug substance, drug product and/or an excipient.
  • Residual solvent testing as per compendia methods.
  • Residual solvent method development, validation, and verification.
  • GMP release testing.

PharmSky also offers the following specialised analytical testing services:

  • Extractables and Leachables
  • MCPD
  • Nitrosamines

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