Analytical Chemistry
We understand the critical role analytical chemistry plays across the lifecycle of pharmaceuticals, medical devices, and combination products. From early API characterisation through development and manufacturing, our experts deliver phase-appropriate method development, validation, QC release testing, stability studies, and more.
Our GMP & GLP accredited laboratories in the UK, US, and EU offer flexible capacity and rapid turnaround times without compromising quality. Backed by over 30 years of analytical experience, our scientists work as an extension of your team to ensure the highest standards of accuracy, reliability, and regulatory compliance.
From residual solvents to particle size, assay to polymorphic form, we offer a broad portfolio of robust and trusted testing techniques. Our commitment to quality, speed, and scientific excellence helps accelerate your path to market with confidence.
A Selection of our GMP / GLP Validated Analytical Equipment​
HPLC Systems
- Agilent 1260 HPLC
- Thermo Ultimate 3000 uHPLC
- Thermo Vanquish uHPLC
- Thermo Altis & Fortis TSQ LC-MS/MS
- Thermo ISQ LC-MS
Detectors
- UV / DAD / PDA
- Refractive Index (RID)
- Charged Aerosol (CAD)
- Fluorescence (FLD)
- Electrochemical (ECD)
Gas Chromatography (GC)
- PerkinElmer GC-FID
- Thermo Trace 1310 GC-FID
- Thermo TSQ EVO GC-MS/MS
- Thermo ISQ GC-MS
- Direct Injection, Headspace & SPME
Additional Techniques
- Metrohm 940 Pro Ion Chromatography
- CD, PAD, Cyanide, Sugars
- Malvern Panalytical OmniSEC Reveal / Resolve SEC/GPC
- Dissolution Testing: USP I, II, IV
Particle Size & Shape Analysis
- Malvern Mastersizer 3000
- Morphologi4-ID
- Sympatec HELOS / RODOS BR
- Microtrac S3500 with ASVR & USVR
- Malvern Spraytec
- Optical Microscopy
Nanoparticle Sizing
- Zetasizer Ultra Red
- Nanosight NS300
- Archimedes RMM
Solid State Analysis
- Bruker D8 & Empyrean S3 XRPD
- APSS Light Obscuration for Sub-Visible Particles
- Micromeritics TriStar 3000 & 3020 BET SSA
- Perkin Elmer DSC 4000 / TGA 8000
- SMS Discovery Aqua DVS
- Scanning Electron Microscopy
Elemental and Other Analysis
- Agilent 7900 ICP-MS
- Thermo iCAP 6500 Duo ICP-OES
- Jasco FTIR 4600 CFR
- Netzsch Kinexus Ultra+ Rheometer
- PerkinElmer Lambda 365 UV/Vis
- Metrohm 852 Combined Karl Fischer with Oven
- Metrohm 904 Titrando
Our Analytical Testing Services
Our analytical chemistry laboratories are equipped with the latest technologies; with our scientist-to-scientist approach, you can directly collaborate with our laboratory team, who will develop and validate bespoke methodologies or establish and verify monographs or client methods tailored to your needs.
GXP Fundamentals
Our expert team ensures that each method we develop is meticulously crafted to meet the highest standards, providing you with reliable and reproducible results every time.
With a unique blend of spectroscopic, chromatographic, solid state and elemental analysis our scientists support your batch release with comprehensive, compliant, audit-ready results delivered with speed and precision.
From our in-house stability suite, Cormica offers GMP / GLP stability studies and ICH storage services to support development, commercial stability studies, shelf-life studies and sample batch release for a comprehensive range of dosage forms, APIs and product types.
We provide a diverse range of physicochemical parameter testing in-house, including OECD and CIPAC methods. We have extensive experience of supporting REACH and 5-Batch Analysis studies.
Physical / Materials Characterisation
Our impressive suite of particle and powder characterisation instrumentation combined with the experience of our analytical team, enables you to understand the properties of your material and develop the optimum product.
From Q1 qualitative assessments through to Q3 microstructural equivalence, our experienced team provide an unrivalled breadth of analytical solutions, techniques and applications to support the ANDA submission process for companies developing generic and complex generic products.
With expert scientists, advanced instrumentation and flexible capacity we facilitate your understanding of key physical properties such as polymorphic form, crystallinity and amorphicity, plus phase identification, phase purity and phase quantification.
Our comprehensive solid state characterisation packages encompass thermal analysis (DSC, TGA), BET-SSA, moisture / solvent content, DVS, and microscopy, along with PSD, XRPD and physical stability.
Chemical Characterisation
Identification and control of organic impurities in a drug substance and drug product is critical to the quality and safety of any drug product. Our comprehensive suite of UPLC and LC-MS instrumentation facilitates the quantitation of a wide range of impurity types.
Due to their potential toxicity the absence/presence of organic solvents must be verified. Cormica have many years of experience of establishing USP <467> compliant residual solvents methods for our customers; alternatively, we can transfer in your validated method or verify our in-house Headspace GC-FID methodology for your product.
With a diverse range of preparation equipment available and both ICP-OES and ICP-MS instruments, our experienced staff will develop a method to meet the specific challenges of your matrix, and the required limits set out in ICH Q3D and USP <232> / <233>.
We provide a comprehensive nitrosamine screening service, along with nitrosamines identification and quantitation, tailored to meet your needs and using instrumentation designed to achieve the lowest detection levels.
Manufacturing & Commercialisation
With extensive experience across multiple surface types using analyte-appropriate highly sensitive instrumentation, our team can support the development / validation of your cleaning regimen, and ongoing cleaning verification campaigns.
Our holistic OH package includes support in OH risk assessment, limit setting, sampling / testing protocols, accompanied by the development / validation of highly sensitive analytical methods for multiple active ingredient types.
We use our expertise and experience, plus unrivalled range of analytical equipment, to help you identify and determine the source of foreign bodies. Our fast turnaround investigations can solve the problem, and help you prevent expensive and frustrating recurrences.
Cormica’s experienced team supports your risk assessment of biocompatibility, encompassing drug products, medical devices, advanced wound management and combination products; a key part of this involves assessing levels of both Extractable (worst case) and Leachable compounds.
Learn More about Extractables & Leachables