What It Covers

Scope of Work

Identity, assay and content uniformity testing for finished drug products

Related substances, impurities and degradation product profiling

Dissolution, disintegration and uniformity of dosage units

Water content (Karl Fischer), residual solvents, elemental impurities

Cleaning verification samples, swabs and rinsates

Forced-degradation studies and stress testing

Method development, validation, transfer and verification

Routine batch release for IMP and commercial product

How We Do It

Methods & Instrumentation

HPLC / UPLC

Reversed-phase, normal-phase, ion-exchange and HILIC for assay, related substances and content uniformity.

LC-MS / LC-MS/MS

High-sensitivity quantification, structural elucidation of impurities, extractables/leachables.

GC / GC-MS / Headspace

Residual solvents (USP <467>, ICH Q3C) and volatile impurity profiling.

ICP-MS

Elemental impurities to ICH Q3D, USP <232>/<233>, Ph. Eur. 2.4.20.

UV-Vis / FTIR

Identity confirmation, content assay and qualitative comparison against reference.

Karl Fischer Titration

Coulometric and volumetric water content for solid, liquid and gas samples.

Dissolution Testers

USP Apparatus 1, 2 and (where appropriate) 3/4 with auto-sampling.

Wet Chemistry

Titrimetric assays, pH, conductivity, refractive index, optical rotation.

Regulatory Framework

Standards This Work Maps Onto

Methods, documentation and acceptance criteria are designed to align with the standards below. This describes design intent — formal accreditations are listed on the About page.

MHRA (Application Submitted)

EU GMP — EudraLex Vol. 4

ICH Q2(R2) — Method Validation

ICH Q6A — Specifications

ICH Q3C / Q3D — Impurities

USP / Ph. Eur. / BP Monographs

What You Receive

Typical Deliverables

Certificate of Analysis (CoA) signed by Quality

Validated method and full method validation report (where in scope)

Method transfer protocol and report when transferring from another lab

Investigational reports (OOS, OOT, deviations) with documented root cause

Specification design recommendation aligned to ICH Q6A

Inspection-ready raw data and audit trail

Who It's For

Sectors We Support

Drug-product manufacturers

API manufacturers

Sponsors running clinical-trial materials

CDMOs requiring an independent contract laboratory

Generics manufacturers preparing UK / EU dossiers

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GMP Contract Testing for Pharmaceutical Products