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Pharmaceutical stability testing

Missouri Analytical Laboratories, Inc. (MAL) has expertise in conducting stability studies for finished dosage forms. We test products by client supplied manufacturer methods or compendial methods. Our experienced, highly qualified analytical team ensures compliance operating under cGMP principles and FDA/DEA guidelines.

 
We test the following dosage forms:

liquids, suspensions, tablets, and capsules. We have the capability of storing and analyzing products for accelerated and long-term stability storage conditions. The typical tests that are performed for stability testing are the following: Assay, Dissolution, and Related Compounds. Other tests that are performed for various dosage forms are appearance, preservative content, alcohol content, disintegration, content uniformity, pH, water content via moisture balance and Karl Fischer.

 
Pharmaceutical Release Testing

We perform finished goods testing as needed for our customers. The finished goods testing is expedited to meet stringent time requirements.

 
Pharmaceutical stability testing

Pharmaceutical stability testing

 
Wet Chemistry testing

We perform various wet chemistry tests including titrations, LOD, disintegration and pH.

 
MTT

All customer methods undergo a full Method Technology Transfer (MTT) or Method Verification prior to analyzing samples. The MTT or Method Verification can follow either a customer provided Method Technology Transfer (MTT) protocol or by using our internal procedures. Method Technology Transfer and Method Verification summary reports are written and provided to the customer following the MTT or Method Verification

 
Method Verifications

Method Verifications for all compendial USP test methods are performed prior to analyzing samples for the first time.