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Drug Substance Analytical Services

Physical and chemical analyses of a wide range of pharmaceutical raw materials and drug substances.

DRUG SUBSTANCE ANALYTICAL SERVICES, MADE TO MEASURE UP

Ofichem specialises in conducting both physical and chemical analyses of a wide range of pharmaceutical raw materials and compounded preparations.

Our services include the analysis of APIs, excipients and finished drug products formulations, such as creams, tablets, capsules, gels and herbal formulations.

We also support pharmacies and hospitals by performing routine analytical testing on compounded medications.

Analytical methods that keep your progress steady

In addition to testing, we develop and validate analytical methods for both new and existing products, ensuring they meet the highest standards. Quality control is a core aspect of our operations.

Our state-of-the-art laboratories are staffed by highly trained professionals with deep expertise in current analytical practices. When needed, all analyses can be performed in compliance with the necessary GMP, ICH and ISO standards.

Testing is conducted according to pharmacopoeial methods (EP, USP, BP, etc.) or specific client requirements. Our analytical methods are developed, optimised, verified (compendial) and/or validated (in-house) in line with applicable ICH guidelines.

Multifunctional, experienced teams

Our analytical development team is not only experienced in working with small molecules, but also has special capabilities for proteins, peptides, antibodies, bioconjugates, oligonucleotides and PROTACs, using specialised techniques such as HIC, SEC and high resolution MS.

Our Capabilities at a Glance

  • Method development and validation for drug substances
  • Forced degradation studies
  • Identity testing, assay and related substances (HPLC/GC)
  • Residual solvents (HPLC/GC) and water content (Karl Fischer titration)
  • Impurity profiling and characterization
  • Nitrosamine testing
  • Particle size distribution (laser diffraction, sieve analysis)
  • Bioanalytical method development and testing
  • Metabolite ID
  • Stability studies design
  • Solubility studies
Man conducting quality assurance and GMP compliance at Ofichem CDMO

Analytical services request

Request a quote or notify us of a sample shipment

Use this form to request a quote for our specialised DS and DP analytical services or to notify our laboratory of an incoming sample shipment.

Providing these details upfront allows our team to review your specifications efficiently and ensure a seamless intake process for your samples.

Fields marked with * are required

Opiate
Stability sample
Analyses to be performed
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Work shoulder-to-shoulder with a family-owned CDMO and pharmaceutical supplier that answers quickly, solves early, and keeps your progress steady. Decisions feel clearer with us beside you.