Pharmaceutical Analytical Testing
Coordinate outsourced analytical work for drug substances, drug products and relevant combination products: stability, dissolution, impurities, extractables/leachables and release testing. Providers perform the work and issue reports under their own quality systems.
Services to scope with a provider
- Stability-indicating method development and stability sample testing; agree storage conditions, time points and specification before placement.
- Dissolution and dissolution-profile comparison for applicable dosage forms, including USP <711> where the monograph or specification calls for it.
- Organic impurities, residual solvents, elemental impurities and targeted nitrosamine testing with product-specific limits and method suitability.
- Extractables and leachables studies for packaging, process equipment and delivery systems; distinguish controlled extraction studies from actual-use leachable assessment.
- Raw-material identification, assay, content uniformity and release testing against an agreed monograph or client specification.
Typical use cases
- Outsourced QC and lot-release support
- Stability programmes and method transfer
- Container-closure or supplier changes
- Investigation of unexpected impurities
Methods, standards and scope
These are general scope summaries, not standards text or a claim about the current edition. Confirm the required edition, local adoption, method suitability and the provider's specific accredited or authorized scope before ordering.
- ICH Q2(R2) and Q14 provide analytical procedure validation and development frameworks; implementation and regional applicability must be checked for your submission.
- ICH Q1 stability guidance informs programmes; do not substitute a generic schedule for the product, market and approved protocol.
- USP <711> is a dissolution chapter, not a universal pass/fail specification. Apparatus, medium, sampling and acceptance depend on the monograph or approved method.
- ICH Q3A/Q3B, Q3C and Q3D address different impurity classes. Analytical detection limits must be justified against the relevant exposure-based or product-specific threshold.
Prepare a useful request
- Drug substance/product, dosage form and market
- Monograph or approved method, specifications and GMP expectations
- Batch/sample count, storage history, reporting and deadline
From request to provider proposal
- Describe your samples, objective, method and timeline once.
- Laboratory Vortex reviews the request and may ask for clarification.
- Independent providers assess feasibility and propose scope, sample requirements and pricing.
- You confirm qualification, confidentiality and contract terms with the provider. Laboratory Vortex does not test samples, issue reports or guarantee quotes or turnaround.