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Pharmaceutical Chemistry Testing

Pharmaceutical Chemistry Testing Services

Whether you need to ensure quality, source new raw materials or ensure the purity and stability of your existing ones, determine residual solvents in your products or confirm the stability of them, we are here to help.

We can also work with you to develop new test methods.

At Lucideon, we provide more than just numbers - we offer solutions to help you develop new products, optimise existing ones, and solve failures quickly

Pharmaceutical Chemistry

 

We are fully GMP-certified for quality control testing of human and veterinary medicinal products. All Lucideon's services are undertaken in compliance with EU guidance on GMP as it applies to contract QC testing laboratories.

In the UK, Lucideon is a UKAS-accredited testing laboratory (No. 0013) and our pharmaceutical/GMP laboratories hold an MHRA certificate of GMP compliance (No. UK GMP 43644 Insp GMP/IMP 43644/34927202-0002, dated 29/02/2024) for contract QC testing of human and veterinary medicines. The Lucideon pharmaceutical/GMP laboratories also hold a current FDA certificate of registration and were successfully inspected by FDA in September 2019.

In the US, Lucideon is Nadcap-accredited and has 10 CFR 50 Appendix B Quality Assurance accreditation.

» Our FDA registration certificate can be viewed here

We are also licensed to handle restricted products. Further details can be provided if required.

Extractables and leachables

Extractables and leachables testing is used to identify such compounds and elements by following ISO 10993 and employing a range of analytical techniques. Our expert analysts can work with you to perform extractables and leaching testing, and subsequently help to minimise associated risks with your products.

QC (batch release) and raw materials testing

Using a wide range of chemical analysis techniques, we provide QC testing of raw materials, APIs, finished products, packaging materials, and medical devices, as outlined in marketing authorisations and pharmacopoeias.

Raw materials testing

Our experts can identify, assay, and determine the quality, purity, and stability of your raw materials to be used in manufacture. Analysis can be carried out in accordance with pharmacopoeial monographs (Ph. Eur., BP, USP and JP) and/or to your specifications.

Residual solvent testing (organic volatile impurities – OVI)

We analyse residual solvents in drug substances, excipients, and products as detailed in the USP-NF Chapter <467>. We can develop and validate methods tailored to your specification if required. Residual solvent testing on pharmaceutical products is required to ensure minimal risk levels, such that they do not impact on patient safety.

 

Method development and validation

Our experienced scientists can develop new methods for your products. These can be developed and validated to ICH guidelines which include the following parameters:

  • Linearity
  • Limit of detection (LOD)
  • Limit of quantification (LOQ)
  • Specificity (including stability of solutions)
  • Precision (method, intermediate and system)
  • Accuracy (recoveries)
  • Robustness
  • Forced degradation

Stability storage and testing

Our storage stability walk-in chambers, controlled to ICH guidelines, are monitored 24/7/365 and have built-in safeguards to give you peace of mind. Additional stand-alone cabinets enable us to offer alternative parameters including refrigerated, frozen, and client-defined storage conditions.

The standard ICH conditions are:

  • 25°C/60%RH - real time storage condition
  • 30°C/65%RH - intermediate storage condition
  • 40°C/75%RH - accelerated storage condition

Our experienced staff can aid with study design, planning, and management of stability storage testing.

Water analysis

Whether it's analysing water quality to pharmacopoeial monographs (Ph. Eur., USP, BP, JP), HTM directives, microbiology of drinking water, or Total Organic Carbon (TOC) - at Lucideon, we can help.

Cleaning and sterilisation validation of reusable medical devices

Medical devices need to be cleaned thoroughly and effectively to ensure safety in use. Reusable devices (such as surgical tools, etc.) require reprocessing (cleaning and disinfection/sterilisation) between each use. To ensure the effectiveness of such reprocessing methods, manufacturers are required to validate their cleaning and disinfection/sterilisation processes as part of the device Instructions for Use (IFU).

 

See our pharmaceutical services video:

White Papers

Protecting Products and Patients in Today's Prescription Drug Abuse Epidemic

In this white paper, we discuss the journey behind Lucideon's proprietary iCRT-deter technology

Single Use Systems
Single Use Systems in the Pharmaceutical Industry - Advantages and Considerations

In this white paper we discuss some of the testing and validation considerations that pharmaceutical manufacturers should look at when implementing single use systems

Quality by Design for the Pharmaceutical Industry

The concept of Quality by Design (QbD) is not a new idea but it is only in recent years that it has been considered for all aspects of the development process for pharmaceutical products

Pharmaceuticals
Abuse Deterrence for the Pharmaceutical Market

This white paper explores the market drivers for abuse deterrence and identifies possible solutions

Tablets
Surface Analysis Exposes Counterfeit Medicines

Surface Analysis is assisting the pharmaceutical industry in a number of ways, including counterfeit detection

Balance
Drying Processes - the Balance Between Efficiency and Product Quality

Drying is an important process in almost all industry sectors, including ceramics, pharmaceutical, food, chemical, construction and semiconductors

Case Studies

Lucideon Supports Wockhardt to Get the COVID-19 Vaccine to Market

Testing carried out at Lucideon's GMP testing laboratories and analytical chemistry facilities

Mouthwash
Visualisation of Oral Microbes in Mouth Care Rinses

Lucideon visually demonstrated the effects of mouthwash treatment

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Environmental monitoring qualification of new facilities

Crystallite Contamination
Crystallite Contamination in a Drug Formulation

Analysis by time-of-flight secondary ion mass spectrometry

Tablets
Surface Yellowing of a Drug Tablet upon Light Exposure

ToF-SIMS investigation into tablet discolouration

Cleaning Product
Lucideon Validates the Efficacy of Sterilising Products

Validation of the effectiveness of detergents, cleaning wipes and spray and wipe products in removing surface bacteria