Contract Services | Analytical capabilities- Pharmaffiliates

Analytical Capabilities

Method Development

Our analytical tools can be leveraged to accelerate the developmental stage of the product. Effective method development ensures that laboratory resources are optimized, while methods meet the objectives required at each stage of drug development.

Pharmaffiliates tests the analytical method extensively for
  • Specificity
  • Linearity
  • Accuracy
  • Precision
  • Ranges
  • Detection limit
  • Quantitation limit
  • Robustness
Analytical Capabilities-Method Development

Method Validation

It is a process of demonstrating that analytical procedures are suitable for their intended use and is required by the regulatory agencies at certain stages of the drug approval process.

Pharmaffiliates typically validates test methods for
  • API
  • Drug products
  • Drug product containers

The process involves a validation protocol that is signed by both the client and Pharmaffiliates. We complete the laboratory work in agreement with the protocol made for the test method that is being validated.

Analytical Capabilities-Method Validations

Method Transfer

Analytic method development, validation, and transfer are key elements of any pharmaceutical development program which are interrelated to each other.

At Pharmaffiliates, Method transfer is the formal process of assessing the suitability of methods developed by us, in another laboratory.

Analytical Capabilities-Method Transfer

Stability Studies and Evaluation

Stability study of a pharmaceutical product is a matter of great concern, in order to study its safety and efficacy throughout its shelf life and it has become a prerequisite for the acceptance and approval of any drug product.

Pharmaffiliates caters its clients with
  • R&D preliminary studies
  • Quality control stability studies and release testing
  • Comparator studies
  • Photostability studies

All stability studies are performed in accordance with the ICH Q1A-Q1F guidelines. Stability indicating methods are developed at Pharmaffiliates Analytical Research Department and these methods are used while performing stability studies for several APIs and Drug products.

Our stability equipments like Stability ovens, walk-in Chambers, and analytical instruments are fully qualified in accordance with the standard operating procedures and all the laboratory instruments are computerized with 21CFR part 11 compliance.

Stability Studies And Evaluation

Structure Elucidation and Evaluation

Pharmaffiliates offers a broad spectrum of structural analytical methods. Apart from the identification of the structure of end product, we elucidate structures of intermediates, impurities, degradation material, metabolites, and other secondary products.

Pharmaffiliates, in consultation with its client, establish the most efficient approach for structure elucidation and evaluation by using latest chromatographic and spectroscopic techniques
  • Ultraviolet light (UV)
  • High-performance liquid chromatography (HPLC)
  • Ultra-performance liquid chromatography (UPLC)
  • Fourier transform infrared spectroscopy (FTIR)
  • Inductively coupled plasma (ICP)
  • Inductively coupled plasma mass spectrometry (ICP-MS)
  • Chiral Chromatography
  • 1D and 2D Nuclear Magnetic Resonance (NMR)
Structure Elucidation And Evaluation