At Honeyman Laboratories, our MHRA-approved cGMP laboratories provide reliable testing for raw materials, APIs, intermediates and finished pharmaceutical products.

Testing is performed in line with global compendial standards (as well as developing and validating bespoke methods), including:

• Ph. Eur. (European Pharmacopoeia)
• USP (United States Pharmacopeia)
• BP (British Pharmacopoeia)
• JP (Japanese Pharmacopoeia)

Why Product & Raw Material Testing is Essential

Pharmaceutical QC testing ensures compliance with mandatory pharmacopoeial specifications and international guidelines:

• Raw materials tested against identity and purity monographs
• APIs and intermediates checked for assay, impurities, related substances and residual solvents (USP <467>, Ph. Eur. 2.4.24, ICH Q3C)
• Finished products assessed for dissolution, content uniformity and stability (USP <711>, Ph. Eur. 2.9.3, 2.9.5, 2.9.6)
• Elemental impurity analysis performed in line with ICH Q3D (Ph. Eur. 5.20, USP <232>/<233>)

By outsourcing to Honeyman, you gain independent, GMP-compliant testing to support regulatory submissions, routine release, stability programmes and OOS investigations.

Example QC Testing Capabilities

(illustrative, not exhaustive – enquire for full scope)

Chromatographic Methods

• HPLC (Ph. Eur. 2.2.29, USP <621>) – assay, impurities, related substances
• GC with Headspace (USP <467>, Ph. Eur. 2.4.24) – residual solvent determination

Elemental & Chemical Analysis

• AAS – trace metals, elemental impurities (ICH Q3D, Ph. Eur. 2.4.20)
• Karl Fischer (Ph. Eur. 2.5.12, USP <921>) – moisture determination
• Titrimetric methods (Ph. Eur. 2.2.20, USP <541>) – acid–base, redox, complexometric, potentiometric
• Loss on drying (Ph. Eur. 2.2.32, USP <731>)
• Residue on ignition / sulphated ash (Ph. Eur. 2.4.14, USP <281>)
• pH (Ph. Eur. 2.2.3, USP <791>)

Spectroscopic Methods

• UV-Vis spectrophotometry (Ph. Eur. 2.2.25, USP <857>)
• FTIR identity testing (Ph. Eur. 2.2.24, USP <197>)

More Than Just a Test List

Honeyman offers:

• Onsite trained samplers for GMP-compliant collection
• Validated transport to maintain chain of custody
• Flexible turnaround times, including rapid release
• Data trending, interpretation and CAPA support
• Method development and validation

Why Choose Honeyman Laboratories?

• MHRA-approved GMP facility
• Proven capability in HPLC, GC Headspace and AAS
• Over 30 years’ pharmaceutical QC experience
• Integrated expertise from across the Honeyman Group

Contact us today to discuss your testing needs or request a tailored quote.