Pharmaceutical Testing

Raw Materials & API Testing

Identity, assay, purity and impurity profiling of active pharmaceutical ingredients, excipients and starting materials — to USP, Ph. Eur. and BP monograph methods, or to client-specific specifications. Supports incoming-goods release, supplier qualification and dossier preparation.

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What It Covers

Scope of Work

API identity, assay and purity (HPLC, UPLC, LC-MS, FTIR, NMR-supported referrals)

Related substances and impurity profiling against ICH Q3A / Q3B

Residual solvents per ICH Q3C / USP <467>

Elemental impurities per ICH Q3D / USP <232>/<233>

Water content (Karl Fischer), loss on drying

Particle size, polymorph identification (XRD on referral)

Excipient testing to compendial monographs

Supplier-comparability and incoming-goods release

How We Do It

Methods & Instrumentation

HPLC / UPLC

Compendial and validated assay, related-substances and content methods.

LC-MS

Trace impurity identification and quantification.

GC / Headspace GC

Residual solvents per ICH Q3C; volatile impurities.

ICP-MS

Elemental impurities to ICH Q3D Class 1/2A/2B/3.

FTIR

Identity confirmation against reference standard or library spectrum.

Karl Fischer

Coulometric water content for hygroscopic and non-aqueous samples.

Wet Chemistry

Compendial titrations, pH, optical rotation, refractive index.

Microbial Limits

Where API monographs require it (USP <61>, <62>, Ph. Eur. 2.6.12, 2.6.13).

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.

USP / Ph. Eur. / BP Monographs

ICH Q3A(R2) — Impurities in New Drug Substances

ICH Q3C(R8) — Residual Solvents

ICH Q3D(R2) — Elemental Impurities

ICH Q11 — API Development and Manufacture

EU GMP Part II — APIs

What You Receive

Typical Deliverables

Compendial CoA for each batch

Impurity profile aligned to ICH Q3A / Q3B reporting thresholds

Residual solvents and elemental impurities reports

Supplier qualification / comparability report

Investigation report when results fall outside specification

Compendial monograph cross-walk for legacy methods

Who It's For

Sectors We Support

API manufacturers

Drug-product manufacturers buying APIs and excipients

Generics filing UK / EU dossiers

Importers needing third-party verification of incoming material

Sponsors qualifying alternative suppliers