SPDS 09052014

8/22/2014

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

13