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the ability to meet the fitness for purpose.
Method Optimization
This method should contains some procedures to verify the
potency of the chondroitinase enzyme. Each lot of enzyme
needs to be tested for potency - use of a COA is not adequate.
The method needs to contain a procedure to verify the purity
of the disaccharide standards. These compounds are very
unique - and purity is important. Using a COA is not
acceptable.
Performance Characteristics
Analytical Range:
The method will cover the analytical range that is specified in
the SMPR. (1-100%)
LOQ:
This method appears to be capable of measure the 1% limit of
quantification that is specified in the SMPR.
Accuracy/Recovery
The method accuracy is reported to be very good - but it is
slightly outside of the SMPR requirements of 92-105% for
finished products.
The method meets the SMPR accuracy requirements of 98-
102% in raw materials.
Precision (RSDr)
The method precision is reported to be very good. The
experiments demonstrated RSDr values for raw materials
were within the SMPR requirement of <2%.
For finished products - some the RSDr values were outside of
the SMPR requirement of <3%
Reproducibility (RSDR)
NA - there was no reproducibility data submitted.
System Suitability
Safety Review
Is the method safe to use as
written?
Yes
Are there any safety concerns
with any component, instrument,
reagent or instruction of the
method? If yes, please clearly
state the concerns.
No
Does the method include all
necessary safety precautions
Yes
CHON-004