SPDS 09052014 - page 105

8/22/2014
13
CPC Titration
CPC cation forms ion pair with large CS anion
Ion pair has poor solubility and causes turbidity
A t f t bidit i
ti
l t
t
moun o ur
y s propor ona o amoun 
of CS in solution and can be measure with 
optical sensor (phototrode)
Non‐Specific
Will react with any large polyanion
Small additions of hexametaphosphate will increase 
results dramatically
Can not be used as stand‐alone method; must be 
used in conjunction with appropriate identity and 
purity tests.
Outcome of WG Meeting on 3/21/14
Proposed Fitness for Purpose Statements
1. Assay Method: Accurately quantify total CS in raw 
materials & finished products as a neat substance 
and in the presence of other ingredients
2. Identity Method (1): Accurately identify CS in raw 
materials & finished products and distinguish CS 
from economic adulterants
3. Identity Method (2): Accurately identify the 
source of CS in raw materials 
4. Purity Method: Detect known adulterants in CS in 
raw materials & finished products at a specified 
level and confidence
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