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Stability Testing of Pharmaceutical Products

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Stability Testing of Pharmaceutical Products

The stability of pharmaceutical products refers to the ability of APIs and preparations to maintain their physical, chemical, biological and microbiological properties. The purpose of stability study is to investigate the changes of the properties of APIs or preparations with time under the influence of temperature, humidity, light and other conditions, so as to provide a scientific basis for the determination of drug production, packaging, storage, transportation conditions and validity. T,C&A Lab runs strictly in accordance with GMP and GLP standards to meet the relevant requirements of compliance, quality, efficiency, etc. We can perform stability testing of pharmaceutical products according to industry standards. Welcome to contact our experts for consultation.

Application range of stability testing

  • Research and development stage

A comprehensive stability test should be carried out to obtain the data required for registration. This data is used to demonstrate the impact of environmental factors on product characteristics to determine packaging, storage conditions, re-test cycle and validity period.

  • Launched stage

After the product is marketed, appropriate continuous stability inspections should be conducted to monitor the stability of the listed drugs, so as to find any stability problems related to the production of the marketed packaged drugs, such as the change of impurity content or dissolution characteristic.

Stability tests for dosage forms

  • Tablets
  • Capsules
  • Emulsions
  • Oral solutions and suspensions
  • Powers and granules for oral solution or suspension
  • Nasal sprays: solutions and suspensions
  • Topical, ophthalmic and preparations
  • Suppositories
  • Small volume parenterals (AVPs)
  • Large volume parenterals (LVPs)

Test methods for stability research

  • Accelerated testing

The accelerated test is mainly used to evaluate the impact of short-term deviation from the storage conditions on the label on the quality of the drug substance. The purpose is to explore the stability of the drug by accelerating the chemical and physical changes of the drug, and to provide necessary information for formulation design, packaging, transportation, and storage.

  • Stress testing

The stress testing is the investigation of the stability of the drug under more intense conditions than the accelerated testing. Its purpose is to explore the inherent stability of drugs, to understand the factors affecting its stability and possible degradation pathways and degradation products, and to provide scientific basis for preparation production process, packaging, storage conditions and establishment of analytical methods of degradation products.

The stress tests include high temperature testing, high humidity testing and strong light exposure testing.

  • Long-term testing

The long-term test is carried out under the storage conditions prescribed by the listed drugs. The purpose is to investigate the stability of drugs in the process of transportation, preservation and use, which can directly reflect the characteristics of drug stability, and is the ultimate basis for determining the period of validity and storage conditions.

Our pharmaceuticals stability testing service can help you

  • Determine the shelf life of the product
  • Give suggestions on the storage conditions of medicines
  • Eliminate the impurities that may be generated during the shelf life of product
  • Help product development, evaluate the physical, chemical and therapeutic stability of product
  • Ensure the purity of the ingredients and the quality of final product
  • Selection of packaging materials
  • Help your product pass ICH and WHO approval

Instruments and data

Stability Testing of Pharmaceutical Products 1
Stability Testing of Pharmaceutical Products 2

Note: the service is for research use only and not intended for any clinical use.

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T,C& A LAB is an independent lab providing quality or custom testing, characterization and analysis of a variety of materials. Our engaged experts are ready to help you.

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