Industries

Pharmaceuticals & Small-Molecule Testing

Contract analytical support for small-molecule pharmaceuticals — APIs, drug products, excipients and intermediates. ICH-aligned method development, validation and release testing for innovator and generic programmes from preclinical through commercial supply.

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What It Covers

Scope of Work

Identity, assay and content uniformity for solid, liquid and semi-solid dosage forms

Related substances, degradation products and impurity profiling

Residual solvents (ICH Q3C) and elemental impurities (ICH Q3D)

Dissolution, disintegration and uniformity of dosage units

Stability-indicating method development and validation

Cleaning verification (swabs, rinsates) and shared-line risk assessment

Forced-degradation and stress studies for stability-indicating power

API release testing against monograph and in-house specification

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

Trace-level impurity quantification, structural elucidation and extractables/leachables.

GC / GC-MS / Headspace

Residual solvents per USP <467> and ICH Q3C.

ICP-MS

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

Dissolution

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

Karl Fischer

Coulometric and volumetric water determination for solids and liquids.

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), Q3A, Q3B, Q3C, Q3D, Q6A

USP / Ph. Eur. / BP Monographs

What You Receive

Typical Deliverables

CoA signed by Quality with full data tables

Method validation / verification reports

Method transfer protocols and reports

OOS / OOT investigation reports with documented root cause

Stability summary reports with shelf-life recommendation

Inspection-ready raw data and audit trail

Who It's For

Sectors We Support

Innovator pharma companies

Generic-drug manufacturers

Contract development & manufacturing organisations (CDMOs)

Sponsors running clinical-trial materials

API manufacturers preparing UK / EU dossiers

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