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The leading resource for scientists who need comprehensive chemical
characterization and development expertise

Search Our Site: Use the up and down arrows to select a result. Press enter to
go to the selected search result. Touch device users can use touch and swipe
gestures.
  


LEADERS IN CHEMICAL ANALYSIS, MATERIALS CHARACTERIZATION, AND SOLID-STATE
DEVELOPMENT

Leverage decades of experience in analytical chemistry,
pharmaceutical solid-form screening and development, cGMP method development,
validation, & lot release, and chemical intellectual property support.

 * Home
 * About Us
   * History, People, Mission
   * 10th Anniversary Letter
   * News and Announcements
   * Scientific Publications and Literature
   * FAQs
   * Upcoming Events & Trade Shows
 * Solid-State Development
   * Polymorphs and Salts - Screening & Selection
   * Cocrystals - Screening, Selection, Formulation Development
   * Non-Crystalline (Amorphous) Materials Characterization, Stability
     Prediction, Development
   * Amorphous Solid Dispersion Development
   * Crystallization Method Development
   * Particle and Habit Engineering
   * Chemical Property Improvement & Problem Solving
 * Materials Characterization
   * Instruments and Techniques Available
     * XRPD Analysis (Transmission, Reflection, VT, VH, Mapping)
     * Thermal Analysis (TGA/DSC)
     * Water Analysis (KF and DVS)
     * Spectroscopy (Raman, FT, IR)
     * NMR (solids, liquids)
     * Microscopy (OM,EM,HS)
     * Chromatography (LC/GC)
     * Elemental Analysis (EDX, PIXE, ICP-MS)
     * Mass Spectrometry (ICP, LC, MS, ToF SIMS)
     * Particle Size Analysis
     * Stability and Dissolution
     * Surface Analysis
     * Other Techniques
   * Pharmaceutical Materials
     * cGMP Materials Testing
     * cGMP Solid Mixture Method Development, Validation, Release Testing
       * Developing GMP Methods for Solids Analysis
       * Reference Standard Qualification
     * Bulk Powder API & Excipient Characterization
     * Compendial Testing (USP/BP/EP/JP, Other)
     * Drug Substance (API) Materials Analysis
     * Physical and Chemical Properties Analysis
     * Chromatographic Purity Analysis (LC/GC)
     * Counterfeit Drug and Patient Complaint Analysis
     * Drug Product Distribution and Composition Analysis
     * CMC Structure Elucidation
     * Particle Size, Count, & Domain Analysis
   * Materials Modeling Services
     * Guidance in Manufacturing and Formulation
     * Prediction of Material Stability, Failure Analysis
     * Habit Modeling and Prediction
     * Indexing, Reitveld Analysis
   * Inorganic Materials Analysis & Phase ID
   * Geo, Petro, and Agro Chemical Analysis
   * Contaminant and Unknown Substance Analysis
   * Biophysical & Biosimilar Characterization
 * Intellectual Property
   * Litigation Support, Reverse Engineering, Consulting, Reproduction of Prior
     Art, IPR
   * Patent Strength Assessment Services
   * Expert Witness Bios
 * Submit Samples
 * Contact Us
   * Request More Info or Get a Quote
   * Address, Map, Directions
   * Departmental Contact Names
 * Employment


SUCCESS IN CHEMICAL DEVELOPMENT STARTS HERE!



CHEMICAL DEVELOPMENT AND ANALYTICAL MATERIALS TESTING IS OFTEN EXPENSIVE,
FRUSTRATING, CONFUSING, OVERLY COMPLEX, AND SLOW - WHICH IS WHY WORKING WITH US
IS NOT.

HAVING A THOROUGH UNDERSTANDING OF THE ASSET'S SOLID-STATE CHARACTERISTICS AND
BEHAVIOR IS CRUCIAL FOR SUCCESS AND CONSISTENCY AT ALL STAGES OF DEVELOPMENT AND
MANUFACTURING - AND ENSURES A STRONG INTELLECTUAL PROPERTY PORTFOLIO.

TRICLINIC LABS PROVIDES INDUSTRY LEADING SOLID-STATE CONTRACT PHYSICAL AND
ANALYTICAL CHEMICAL ANALYSIS, DEVELOPMENT, AND PROBLEM SOLVING - WITH A SENSE OF
URGENCY. DERISK YOUR DEVELOPMENT PATH!


WE HAVE NEARLY FOUR DECADES OF TRUSTED CONTRACT CHEMICAL RESEARCH EXPERIENCE -
DEDICATED TO IMPROVING YOUR UNDERSTANDING OF YOUR MOLECULES AND THEIR POTENTIAL.


Triclinic Labs, Inc. offers contract research services that can be broadly
characterized as "physical and analytical chemistry". More specifically, the
search and development of solid forms and the use of analytical instrumentation
for the characterization of those molecules. These services go hand in hand with
our intellectual property patent prosecution and litigation support services.

Founded in 2009, we are an FDA registered and inspected laboratory (2016) with a
DEA Controlled Substance License (Class I-V). We lead the industry in innovative
approaches to chemical development and analysis. Our goal is to provide the most
comprehensive solid-state analysis, screening and selection, interpretation, and
intellectual property guidance. We strive to help you achieve milestones and
make your programs more successful - we'll collaborate with you to provide a
path forward, not just deliver a stack of test results or a data dump.


> YOU'LL FIND WE'RE UNIQUE AND:
> 
> RESPONSIVE -
> 
> Receive a rapid reply to requests. Experience on time and on budget projects.
> You'll find the sense of urgency and timeliness that you expect, but rarely
> find in a contract research organization. We have numerous services levels and
> can accommodate rush requests.
> 
> AVAILABLE -
> 
> Work directly with our lead scientists. No project managers or communication
> and time zone barriers. Receive project updates when you need them. Every
> employee is empowered and expected to do the right thing for the client.
> 
> FLEXIBLE -
> 
> We offer BOTH cGMP and non-GMP services, extensive and rapid materials
> characterization, we can accommodate unusual requests (e.g. medical devices
> and exotic materials), and don't charge for minor changes or project
> modifications.
> 
> COST EFFECTIVE -
> 
> We offer various levels of service and scope. We'll tailor a program to meet
> your needs, not apply a boiler-plate approach that is used over and over.




EXTENSIVE EXPERIENCE:



You receive actionable results, not a data dump.

Everyone says they are the best. We want to prove it to you. The scientists at
Triclinic Labs have nearly four decades of chemical and pharmaceutical analysis,
development, and intellectual property (IP) support experience. We've
collaborated on several thousand polymorph, salt, cocrystal, crystallization
process improvement, and amorphous material development projects. We have
characterized innumerable organic and inorganic molecules, drug products, and
medical devices. Our scientists have served as experts in more than 200 IP
matters world-wide over the last 25 years. We've worked with every therapeutic
class of active pharmaceutical ingredients and hundreds of formulations and
excipients. Our client repeat rate is 98.3% historically. We believe it's
because we quickly help solve your problems and are fair and consistent in
serving our clients.

We can help you with even the most challenging solid-state chemistry analysis,
development, and control issues. Our scientists have a tool box full of
techniques to render your molecule crystalline and an extensive array of
instruments and approaches to analyze your drug substance, drug product,
contaminants, and counterfeit chemicals.







SERVICES WE OFFER-

For R&D scientists looking for a different kind of contract research group -
trust us as your source for expert solid-state development, testing, consulting,
and intellectual property support: See below for a full list...




SOLID FORM SCREENING, SELECTION AND API PROPERTY IMPROVEMENT

 1. Polymorph and Salt Screening and Selection
 2. Cocrystal Screening, Selection, and Formulation Development
 3. Crystallization Method Development
 4. Problem Solving: Improvement of Physical &
    Chemical Properties


ANALYTICAL CHEMISTRY AND MATERIALS CHARACTERIZATION

 1.  Pharmaceutical and Fine Chemical Materials Analysis
 2.  Inorganic Materials Analysis and Phase Identification
 3.  Contaminant and Foreign Material Identification
 4.  Reference Standard Characterization
 5.  CMC Structure Elucidation and Submission Services
 6.  Bulk Powder Characterization
 7.  Particle Size and Domain Analysis
 8.  Drug Product Mapping and Composition Analysis
 9.  cGMP Analytical Method Development, Validation, Transfer
 10. Large molecule and Biosimilar Characterization


AMORPHOUS MATERIALS & SOLID DISPERSIONS DEVELOPMENT

 1. Non Crystalline Materials Property & Stability Prediction
 2. Formulation Screening, Development, Characterization


INTELLECTUAL PROPERTY SUPPORT

 1. Chemical Patent Prosecution and Litigation Support
 2. Pharmaceutical Expert and Fact Witnessing
 3. Reproduction of Prior Art for ANDA and Other matters
 4. Chemical Patent Strength Assessment
    
    

Some of the Analytical Techniques we offer:
XRPD
DSC, TGA
Optical and Electron Microscopy
Raman, FTIR, and IR Spectroscopy
DVS and KF
Elemental Analysis
NMR (solids/liquids)
HPLC, UPLC
GC with Headspace
LC/MS and LC/MS/MS
Particle Size Analysis
Bulk Powder Analysis
Dissolution and Stability
If you'd like more information on any of the TECHNIQUES you see, just click
here!




HOW TO COLLABORATE WITH US...


It's easy to begin a discussion on your project needs but the devil is in the
details. Generally, we begin with a mutual confidentiality agreement. We're
happy to use your preferred document as a starting point. Once executed, a
project discussion with your subject matter expert and ours is is a good next
step. We will prepare a project scope and cost proposal from that discussion (or
discussions). Usually some refinements are made to the project scope. Once the
project is executed with a confirmed start date and receipt of samples, we'll be
in regular contact as the project progresses. Biweekly project updates for
longer duration projects are provided. You can communicate with the project
leader as needed too. It's efficient - because it should be.

If you'd like to get started please click here.

Solvias, SSCI, AMRI, Curia Global, Catalent Pharma, Solid State Pharma Inc,
Avomeen, J-Star, Dalton Pharma, Ardena, Crystallics, Pharmorphix, ALMAC

--------------------------------------------------------------------------------

News and Announcements:


--------------------------------------------------------------------------------

Request More info or a Free Consultation (click)or Call 765.678.7528

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Triclinic Labs, Inc.
2660 Schuyler Ave. Ste. A.
Lafayette, IN 47905 USA
PH: +1.765.678.7528

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