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Pharmaceuticals/Titanium Dioxide Identification test


QUESTION: why identification test for titanium dioxide is required in the Finished product specifications when used as coating component for tablets?
Thank You

ANSWER: Sorry but I have insufficient information to answer your question.
Please advise which specific finished product and which specific pharmacopoeia are you referring to?

---------- FOLLOW-UP ----------

QUESTION: Ok, we are an Egyptian company. We plan to have the EMEA approval. we have received the technical transfer file for Citalopram 20mg tablets. In the specification table of the Finished product the test of Identification of Titanium dioxide is required. my question is why Titanium dioxide specially is required for identification? as I know only Citalopram hydrobromide identification test is should to be required and the excipients are not require to be identified....
Thank you

The answer is any of the following:
a. The product is listed in the European Pharmacopiea, and Ph.Eur. requires the test on the finished product;
b. Whomever you purchased the dossier from, included the test to show equivalence to the originator drug;
c. Because !!! ............ Who knows???  

If you want, you can submit a variance to the authorities to drop the test, but wait until your GMP inspection is over and successfully passed.


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Michael Anisfeld


Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements


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