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Pharmaceutical Research
Preparation Quality Research
With decades of working experience, our CMC experts are familiar with various ICH and NMPA regulations and guidelines, and have helped clients complete their preformulation and pharmaceutical preparations studies to provide reliable data for the filing materials. We have successfully assisted our clients in completing the filing of Class 1.1, Class 3.1 and Class 6 new drugs at NMPA.
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Preformulation Study
  • Preclinical evaluation of candidate compounds
    ItemsDescription
    Crystal formsCrystal form determination by X- ray diffraction or DSC
    Solubility

    Curve of solubility in acid and base solutions

    Solubility in organic solvent

    Solubility in compound solutions of different salt forms

    Solubility in simulated fasting intestinal fluid

    Solubility in simulated feeding intestinal fluid

    Solubility in simulated artificial gastric fluid

    Stability

    Solution stability

    Solid stability

    Photostability

    pH stability

    Inherent propertiesDissociation constant and oil-water distribution coefficient
  • Formulation selection related
    ItemsDescription
    Particle size distributionWet (more preparation required, preferably 1g) or dry method (data not as accurate as wet method)
    Solubility regarding pH changesSolubility under water and solutions with pH values of 1.2, 4.5 and 6.8
    HygroscopicityWeight increase within 24 hours under different humidity conditions based on Chinese Pharmacopoeia
    FluidityEvaluation by angle of repose or Carr index
    Compatibility of ingredientsInteraction between APIs and selected ingredients
    Residual solventMethod for detecting gas phase
    Microscopic observation, melting point, Pka, moisture, optical isomers, related substances, etc.
Method development
  • Related substances are impurities in drugs except the main components. They may be raw materials, intermediates, reagents, decomposition products, by-products, polymers and isomers brought in during the synthesis of APIs, and degradation products produced during storage, transportation and use. As the content of related substances is generally small, it is very important to choose a detection method featuring good specificity, high sensitivity and great reproducibility. For drugs beyond standards, the methods of related substances shall be developed according to drug properties, product characteristics, FDA, pharmacopoeias of various countries, relevant materials, and optimized to meet the requirements of ICH and pharmacopoeias of various countries for related substances. For drugs within national standards, it is not acceptable to refer to existing national standards mechanically. The principle shall be “follow the category not the standard”, i.e., in the research of drugs within existing national standards, the safety and effectiveness of the developing products should be consistent with those of the products available on the market, and specific standards shall be set for specific categories.
Verification of analytical method
  • Analytical methods shall be verified based on the characteristics of drugs and the requirements of ICH and pharmacopoeias of various countries.
    Method verification for enantiomerMethod verification for related substancesMethod verification for content uniformityMethod verification for content determination Method verification for microorganismMethod verification for dissolution determinationBacterial endotoxin test for drugsDetermination of impurity contentVerification contents include: specificity, linear range, accuracy, precision, detection limit, quantitative limit, durability, system adaptability, etc. The specific verification contents shall be subject to the requirements of pharmacopoeias.
Stability Study
  • Verification of analytical methods provides scientific basis for the determination of production, packaging, storage, transportation conditions and validity period of pharmaceutical products by investigating the laws of the changes of the properties of APIs and preparations with time under the influence of temperature, humidity and light, so as to ensure the safety and effectiveness of clinical medication. Stability study is one of the main contents of drug quality control research. It is closely related to drug quality research and the establishment of quality standards. The research on preparation stability is featured by phases and links all steps in drug R&D.
    Different placement conditions for stability study based on different formsDifferent investigation items based on different formsDifferent packaging materials based on different formsInvestigation of physicochemical properties and stability of drugs based on time changeScheme design of stability study, project management, storage and detection of samples for stability study, data trend analysis, and evaluation of drug shelf life
Detection of microorganism
  • Antibacterial test of drugsSterility test of sterilized preparationMicrobial limit test of non-sterilized preparations
Relevant laboratories
Relevant articles