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For the full listing of excipients, look section 6.
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Do you need qtpp for Ace tablet case study?
Since ACE Tablet case study did not provide QTPP’s, I recommend beginning from the same set from the the Immediate Release Tablet case study. Then you can customize from there. You can see the QTPP’s in Lean QbD Risk Assessment template for ACE Tablets below. Then I used Table 1 (above) for CQA’s.
What is the manufacturing process for acetriptan tablets?
Manufacturing process involves a pre-blending step, roller compaction of the acetriptan with microcrystalline cellulose, croscarmellose sodium, magnesium stearate and lactose monohydrate, then milling to produce granules before blending with magnesium stearate, and talc. This is then followed by compression on a rotary tablet press.
How many tablets are in a 30cc HDPE bottle?
10 tablets are packaged into 30cc HDPE bottles containing cotton wadding and a heat-induction seal, closed with polypropylene caps and 6 tablets per blister with push-through foil lidding. Now that we’ve done all of the hard work we can summarize the CPPs and CMAs into the Lean QbD table below.
What are the CPP attributes of Ace tablets?
The ACE tablets case study does not mention much about the CPP’s related to the packaging process. Main attributes associated with this process would be stability.
Last Update: Oct 2021
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