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Physical & Analytical Chemistry

Physical & Analytical Chemistry

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Solid State Chemistry Educational Survey
Solid State Chemistry plays a very important role in the development of a drug. This includes polymorphs, cocrystals, salts and amorphous materials as well as the analysis of an API and a drug formulation with regard to their solid-state chemistry properties.

Please help us to gauge the industry's interest in an educational Solid State Chemistry course by participating in the survey:
Solid State Chemistry Educational Survey - 10% Discount
Please click here to fill in the questionnaire and register for your 10% discount off any Aptuit hosted short courses.
Solid State Chemistry Educational Survey - Anonymous
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To register for your 10% discount off any Aptuit hosted short course please fill in your details below:
Your first name:  
Your last name:  
Your company
name:  
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address:    
Your contact
phone number:  
Your country:  
Simply check the most appropriate answer box for each question and click submit when you have finished:
Have you ever attended an SSCI short course?  
If yes, please rate your experience:
(from 1:Poor to 5:Outstanding)
If no, why not?
Would you be interested in a short course on Solid State Chemistry?  
What would be the ideal length of a course of this nature?
Would you be willing to pay for the educational course, if so up to how much?  
Would you be willing to travel to the course?
What level of knowledge should the course cover?
What do you normally look for when attending these types of events?
(check all that apply)




Solid State Chemistry plays a very important role in the development of a drug. This includes polymorphs, cocrystals, salts and amorphous materials as well as the analysis of an API and a drug formulation with regard to their solid-state chemistry properties.

Please provide any specific topics you would like to see covered in a course of this nature:  
Please provide the names of any specific speakers you would like to see present at the course, e.g. leading academics, representatives from government:  
Simply check the most appropriate answer box for each question and click submit when you have finished:
Have you ever attended an SSCI short course?  
If yes, please rate your experience:
(from 1:Poor to 5:Outstanding)
If no, why not?
Would you be interested in a short course on Solid State Chemistry?  
What would be the ideal length of a course of this nature?
Would you be willing to pay for the educational course, if so up to how much?  
Would you be willing to travel to the course?
What level of knowledge should the course cover?
What do you normally look for when attending these types of events?
(check all that apply)




Solid State Chemistry plays a very important role in the development of a drug. This includes polymorphs, cocrystals, salts and amorphous materials as well as the analysis of an API and a drug formulation with regard to their solid-state chemistry properties.

Please provide any specific topics you would like to see covered in a course of this nature:  
Please provide the names of any specific speakers you would like to see present at the course, e.g. leading academics, representatives from government:  
Solid State Chemistry Educational Survey


Thank you


Your comments are appreciated. If you have registered for your 10% discount, please claim this at the time of booking your Aptuit-hosted course.
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Stability Testing and Sample Storage

At Aptuit, the stability testing and sample storage options represent extensive, comprehensive programs that provide fully validated and continuously monitored storage environments for all ICH and WHO (including e.g. ASEAN countries) test conditions. In addition, we can provide analytical capabilities to evaluate the physical, chemical, and microbiological properties of solids, liquids, semisolids, and parenteral formulations.

We can also support study design and management of forced degradation studies to assess the “stability-indicating” power of the analytical methods under development for stability testing, statistical support for stability testing includes support in both sample management (i.e. statistical randomization sampling plans) and statistical evaluation of both long-term (i.e. in line to ICH guidelines) and accelerated (i.e. for both traditional Arrhenius temperature and newer temperature/humidity Accelerated Stability Assessment Program approaches) stability data.

All of our analytical equipment is qualified and calibrated with full documentation covering the IQ/OQ/PQs, as well as routine and non-routine maintenance. Our access to validated data handling networks allows us to compile and deliver data to our clients quickly and efficiently.

We can therfore provide the following integrated services in the stability field:

  • Stability Protocol Design per ICH and for global registration
  • Forced degradation studies protocol design and study management
  • Stability study management with physical, chemical and microbiological testing of samples 
  • Evaluation and reporting of Stability Data
  • IND/NDA/IMPD/MAA/CTA filable data tables and text comments 
  • Statistical evaluation of data
  • Sample storage in fully mapped, qualified, and continuously monitored walk-in and reach-in chambers

 Conditions for walk-in and reach-in chambers:

 

• 5°C/ ambient humidity      • 30°C/75% RH
• 15°C/75% RH                  • 30°C/ambient humidity
• 25°C/40% RH                  • 40°C/ambient humidity
• 25°C/60% RH                  • 40°C/NMT 25%RH
• 25°C/75% RH                  • 40°C/75% RH
• 25°C/90% RH                  • 50°C/ambient humidity
• 30°C/35% RH                  • 60°C/ambient humidity
• 30°C/60% RH#                • -20°C/ambient humidity
• 30°C/65% RH                  • -70°C/ambient humidity
• 30°C/70% RH                  • ICH Photostability Option 2
                                        • Thermal cycle exposure

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