Stability Studies

Stability Studies
Product Description

PolyCrystalLine offers a wide range of Pre-formulation studies which includes Stability studies. Its thermodynamic relationships between polymorphic forms is crucial and must be established carefully, because as drug crystallises from different conditions the kinetically favoured metastable polymorph appears first. It may undergo environmental induced transformation to produce thermodynamically stable form at its own expense, affecting important properties such as the ability to process and/or manufacture the drug substance and the drug product, as well as on drug product stability, dissolution rate, and bioavailability. Contact us for more information.

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PolyCrystalLine S.p.A

  • IT
  • 2015
    On CPHI since
  • 2
    Certificates
  • 25 - 49
    Employees
Company types
CMO/CDMO
Contract Service
Primary activities
API Producer
Contract Research Organisation
Custom Manufacturing/Custom Synthesis
View company profile
Categories
more categories Show less
Specifications
  • Selling Points
    Experienced Technicians; Quality Service
  • Supplied from
    Italy
More specifications Fewer specifications
Sales Markets
Show more Show less

PolyCrystalLine S.p.A

  • IT
  • 2015
    On CPHI since
  • 2
    Certificates
  • 25 - 49
    Employees
Company types
CMO/CDMO
Contract Service
Primary activities
API Producer
Contract Research Organisation
Custom Manufacturing/Custom Synthesis
View company profile

More Products from PolyCrystalLine S.p.A (17)

  • Method Development & Validation

    Product Method Development & Validation

    PolyCrystalLine offers a wide range of analytical services which includes method development & validation. It can be entrusted with the most sensitive projects for method development and validation of api’s intermediates, raw materials and finished products. Contact us for more information.
  • Physical Characterization

    Product Physical Characterization

    PolyCrystalLine offers a wide range of analytical services which includes physical characterization. Its an physicochemical properties of a compound is essential so that the formulation process can be rational and streamlined. Contact us for more information.
  • Polymorph Screening

    Product Polymorph Screening

    PolyCrystalLine offers a wide range of solid form screening which includes polymorph screening. In an early stage of drug development helps to avoid manufacturing problems, to fine-tune the performance of drugs and provides space for innovations. Contact us for more information.
  • Route scouting

    Product Route scouting

    API route scouting, up to kilo-Lab
  • Salts Screening

    Product Salts Screening

    PolyCrystalLine offers a wide range of solid form screening which includes salts screening. It is one of the primary solid-state approaches used to modify the physical properties of apis, a major limitation within this approach is that the api must possess a suitable (basic or acidic) ionisable site. Conta...
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    Product Solvates/Hydrates Identification

    PolyCrystalLine offers a wide range of solid form screening which includes solvates/hydrates identification. It is an amorphous and crystalline forms, a solid drug may be anhydrous or a solvate/hydrate. When a solid form contains a solvent, it is known as a solvate. Contact us for more information.
  • Structural Characterization

    Product Structural Characterization

    PolyCrystalLine offers a wide range of analytical services which includes structural characterization. Its an characteristics of the unit cell can be used to predict the morphology and physical properties of a drug, provides phase identification of a crystalline material and information on unit cell dimens...
  • Thermal Analysis

    Product Thermal Analysis

    PolyCrystalLine offers a wide range of analytical services which includes thermal analysis. Its an indicator of conformational stability, reaction-rates and composition of the sample. They are also useful for determining sample purity and water, carbonate and organic contents and for studying decomposition...
  • cGMP Manufacturing

    Product cGMP Manufacturing

    Our new small molecule API custom manufacturing capabilities integrated with our R&D facility will allow PolyCrystalLine CDMO to bring your project from early phase development to scale-up and commercial manufacture ensuring the right solid forms. We have been doing this for many years. PolyCrystalLine CDM...
  • Process Development

    Product Process Development

    We can optimise synthesis and crystallization processes, ranging from synthetic route scouting to process scale-up allowing for batches of grams to kilograms of small-scale production, while ensuring flexible and robust procedure that can easily be transferred to pilot-scale, and finally to high volume ind...
  • Api-Excipient Compatibility Studies

    Product Api-Excipient Compatibility Studies

    PolyCrystalLine offers a wide range of Pre-formulation studies which includes API-excipient compatibility studies. It contains excipients which can affect the chemical, physical and therapeutical properties, product stability and may even cause a change in the API polymorphic form. Its interactions is a cr...
  • Cgmp Quality Control

    Product Cgmp Quality Control

    PolyCrystalLine offers a wide range of analytical services which includes cgmp quality control. Its provide a full complement of state-of-the-art gmp analytical testing resources and expertise to support cgmp quality control testing for raw materials, active pharmaceutical ingredients (api) and intermediat...
show all 17 other products

PolyCrystalLine S.p.A resources (1)