Clearsynth demonstrates the ability to consistently provide products and services that meet customer and regulatory requirements. With the Certified Reference Material (CRM) or Reference Material Grade (RMG) comes the Certificate of Analysis (CoA). Within the CoA, there are several quality parameters which are critical to understand – Accuracy, Consistency, Homogeneity, Purity and Stability.
During all our synthesis we strictly adhere to the following 5 parameters:
Accuracy and reliability of analytical results is dependent on accuracy and reliability of the method of analysis, accuracy in the preparation of samples and accuracy of the calibrators used and Comparison to a primary source or certified second source – curve/calibration standard.
Consistency between Lots is confirmed by comparing to the prior Lot.
Homogeneity is an important parameter across the batch of ampoules/vial. It Involves replicated measurements on multiple units or subsamples of the material.
The quality and purity of Reference Standards are crucial to determining scientifically valid results for many pharmaceutical analytical methods.
Expiration date established through real-time stability study.
At Clearsynth, we believe, documenting and reviewing the structure, responsibilities and procedures are required to achieve effective quality management in an organization.