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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