Raw Materials Testing (Excipients & APIs)

Our Raw Materials testing for pharmaceutical products involves the analysis and evaluation of the ingredients or components used in pharmaceutical production. It is a critical quality control measure aimed at ensuring that the raw materials meet the required specifications and standards. Working closely with our microbiological lab department, we offer the following services, among others:

  • Analysis of degradation products
  • Determination of residual solvents
  • Assay testing
  • Identification of components
  • Measurement of water content
  • Physical testing, such as Sulphated Ash, Residue on Ignition, Loss on Drying, Viscosity, Conductivity, Density, and pH
  • Assessment of microbial contamination through bioburden analysis

GMP Batch Release Testing

Our GMP Batch Release Testing entails the analysis and evaluation of final pharmaceutical products once their manufacturing process is complete. This step is crucial in quality control to ensure that the pharmaceuticals meet the required specifications, safety standards, and efficacy.

Batch Release testing serves to verify the quality, identity, strength, purity, and performance of pharmaceutical products before they are released for distribution and use.

Here, at Tentamus Pharma UK, both chemistry and microbiological labs collaborate to provide a wide range of pharmaceutical tests tailored to clients' requirements and specifications. Here are some of the GMP testing services we offer:

  • Dissolution testing
  • Tablet/capsule testing, including disintegration, hardness, and friability
  • Residual solvents analysis
  • Analysis of related substances and impurities
  • Assay testing
  • Identification of components
  • Physical testing, such as Loss on Drying, Viscosity, Density, Osmolality, and pH
  • Particulate analysis
  • Inhaler testing, including ACI and UDD methods
  • Microbial Limits Test
  • Sterility Testing
Finished Product Testing V1 ma

Stability Studies

Stability study services are a set of tests and evaluations conducted to assess the stability and shelf-life of pharma products over time. These studies are essential in determining how a product's quality and characteristics change under various environmental conditions, including temperature, humidity, light exposure, and storage duration.

  • Storage conditions
    25°C / 60%RH, 40°C / 75%RH, 30°C / 65%RH, 30°C / 75%RH, Refrigerated 2-8°C
  • All-inclusive service for your product to ICH guidelines
  • Writing protocol
  • Storing samples in designated storage conditions
  • Pulling samples at specified timepoint
  • Testing of samples on site
  • Generation of full stability report at each time point

Method Development & Validation

Our Method Development and Validation specialists are experienced in creating and establishing analytical methods used to test the quality, identity, potency, purity, and safety of pharmaceuticals. These methods are crucial for ensuring accurate and reliable analysis of the active pharmaceutical ingredients (APIs), excipients, impurities, and other components present in the products.

We specialise in:

  • Identification Testing
  • Related Substances & Impurities Analysis
  • Potency/Assay Assessment
  • Cleaning Validation
  • Dissolution Testing
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