Dear Sir:
We are third party testing and certification agency and our company name is
INTERTEK Testing Service., LTD. Now we have some puzzlement during providing
testing services for our client (General Electric). We did melting point testing of
polypropylene according to FDA CFR Title21. § 177.1520. In this part of
regulation, there have the descriptions, as “The melting point shall be determined
by ASTM method D2117–82, “Standard Test Method for Melting Point of
Semicrystalline Polymers by the Hot Stage Microscopy Method”. But as we
known, ASTM had withdrawn the method ASTM D2117-82 in 1994. Check the
ASTM web site for verification. This ASTM method is called the HSC (Hot stage
microscopy). So we want to know if there has replacing method or exclusive
method for this test item. Thanks.
Intertek Testing Service,Ltd - Comment
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Public Submission Posted: 08/08/2008 ID: FDA-2008-N-0397-0002
Sep 16,2008 11:59 PM ET