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ABOUT US

Seven Star Pharmaceutical Services is a technology-driven Contract Research Organization (CRO) that focuses on solving the drug development problems through solid state chemistry/materials science and engineering principles.  We work with our clients to ensure comprehensive solutions for their needs in solid-state chemistry research, crystallization process development, and preformulation studies.  Based on the molecular level understanding of materials, we guide clients in the discovery and selection of the optimal solid form for drug development using all aspects of pre-formulation studies, including API process development, regulatory support and intellectual property protection.  We are flexible and deliver timely, practical, and cost-effective solutions.  Our programs include salt screening, co-crystal screening, crystallization screening, polymorph screening, amorphization, scale-up crystallization, physico-chemical properties testing, particle engineering and structure elucidation of solid forms by single crystal X-ray diffraction.

CMC/Solid State Chemistry Development Support

At Seven Star, we offer CMC/solid state chemistry development support services on FTE based as well as project based.  In addition, for research based organizations we are also offering these services on annual contract basis.  Please reach out to us for more information. 

Our solid state development programs include but not limited to:

  1. Solid Form screening and selection

    1. Polymorphs, salts, co-crystals

    2. Crystal screening to crystallize amorphous and difficult to crystallize molecules

    3. Evaluating stability of polymorphic transformations

    4. Selection of a solid form suitable for the development program

    5. Scale-up of desired solid form (mg to g quantities to enable preliminary studies in the development program)

  2. Crystallization

    1. Crystallization optimization to improve yield, chemical purity, polymorphic purity, size and shape of the particles

    2. Chiral resolution by preferential crystallization

  3. Method development and miscellaneous services

    1. Determining amorphous content in drug substance

    2. Polymorphic purity determination

    3. Validating presence of the desired solid form in drug product

    4. Amorphous solid dispersions

    5. Cryomilling to generate amorphous solids

    6. Log P determination of a drug substance

    7. pH dependent solubility determinations

    8. Kinetic/thermodynamic solubility determination of solid form

    9. Regulatory support

    10. IP Litigation Support

  4. Structure determination from single crystal X-ray diffraction

    1. Absolute stereochemistry determination

    2. Chemical composition and structure of a compound, atomic connectivity, accurate bond lengths and angles, density, packing, hydrogen bonding networks, presence of channels, and solvent location.

  5. Routine analytical testing by

    1. X-ray Powder Diffraction (XRPD)

    2. Structure elucidation by Single Crystal X-ray Diffraction methods (SCXRD)

    3. Differential Scanning Calorimetry (DSC)

    4. Modulated Differential Scanning Calorimetry (mDSC)

    5. Thermogravimetric analyses (TGA)

    6. Dynamic Vapor Sorption (DVS)

    7. Polarized Light Microscopy (PLM)

    8. Hot Stage Polarized Light Microscopy (HS-PLM)

    9. Karl Fischer Titration (KFT)

    10. Elemental Analyses (CHNS analyses)

    11. Fourier-transform infrared (FTIR) spectroscopy

    12. Raman Spectroscopy

    13. High-performance liquid chromatography (HPLC) 

    14. Liquid chromatography–mass spectrometry (LC–MS)

Single Crystal XRD

STRUCTURE DETERMINATION FROM SINGLE CRYSTAL XRD

Scientists routinely use techniques such as NMR (including COSY, NOESY, HETCOR ….), IR, Raman and UV spectroscopy, mass spectrometry, and elemental analysis for the identification and characterization of compounds. After a tedious analysis and interpretation of the experimental data, obtained from these techniques, may yield important information concerning the composition and structure of a compound. However, such information is often incomplete, fragmentary and ambiguous.


In contrast, single crystal XRD one of the most powerful techniques to determine with certainty three-dimensional arrangement of atoms/ions in crystalline materials.  It provides lots of information such as the composition and structure of a compound, atomic connectivity, confirmation (including the absolute stereochemistry), accurate bond lengths and angles, density, packing, hydrogen bonding networks, presence of channels, and solvent location.

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Figure 1.  X-ray diffractometer with Cu source and an extremely sensitive Photon II CPAD detector.


At Seven Star, we have Bruker D8 Quest single crystal X-ray diffractometer instrument with Cu source and an extremely sensitive Photon II CPAD detector (Figure 1).  It is also equipped with an Oxford Cryosystems Cryostream device for low temperature data collection capability down to about 90 K.

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For all the solid form screening projects, we always strive to provide single crystal structure for every crystalline form we discover most importantly without an extra charge. 

ANALYTICAL TESTING SERVICES

Seven Star Pharmaceutical Services also offer routine testing on pharmaceutical solids at highly affordable pricing without compromising on its quality.  It is our commitment and vision to make the drug development costs affordable.

MEET THE TEAM

Seven Star Pharmaceutical Services team has more than 10 years of experience in solid form screening & selection, supporting pre-formulation and formulation development programs.  Providing molecular level of understanding of the materials is the specialty of this team.

Contact Us
CONTACT US
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