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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Testosterone No Good After 28 Days???
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<blockquote data-quote="Cataceous" data-source="post: 204182" data-attributes="member: 38109"><p>Because nobody wants to follow the link I'll duplicate the information here. The figure of 28 days comes from the United States Pharmacopeia (USP) standard:</p><p></p><p style="margin-left: 20px"><em>Multiple-Dose Container: (see 659) A multiple-unit container for articles or preparations intended for parenteral administration only and usually containing antimicrobial preservatives. <strong>The beyond-use date (BUD) for an opened or entered (e.g., needle-punctured) multiple-dose container with antimicrobial preservatives is 28 days</strong> (see Antimicrobial Effectiveness Testing 51), unless otherwise specified by the manufacturer.</em></p><p><a href="https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/gc-797-rb-notice-20200424.pdf" target="_blank">https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/gc-797-rb-notice-20200424.pdf</a></p><p></p><p>The USP standard is federal law. Therefore healthcare professionals might reasonably be unwilling to contradict the directive. There are no qualifiers like "should" in the standard. "<strong>The beyond-use date ... <u>is</u> 28 days...</strong>"</p><p></p><p style="margin-left: 20px"><em>Prescription and over-the-counter medicines available in the United States must, by <a href="https://en.wikipedia.org/wiki/United_States_Code" target="_blank">federal law</a>, meet USP-NF public standards, where such standards exist.</em></p><p>[URL unfurl="true"]https://en.wikipedia.org/wiki/United_States_Pharmacopeia[/URL]</p><p></p><p><a href="https://menmd.com/category/menmd-articles/multi-dose-vials-and-the-28-day-sterility-rule/" target="_blank">This article</a> is quite cautionary and explains the challenge tests required of manufacturers.</p><p style="margin-left: 20px"><em>Without getting into the incredibly detailed science describing these tests, it has been accepted that multi-use vials can only be used safely for 28 days after the first puncture.</em></p><p></p><p>More details on Antimicrobial Effectiveness Testing here:</p><p>[URL unfurl="true"]https://latam-edu.usp.org/wp-content/uploads/2021/01/USP-NF-51.pdf[/URL]</p></blockquote><p></p>
[QUOTE="Cataceous, post: 204182, member: 38109"] Because nobody wants to follow the link I'll duplicate the information here. The figure of 28 days comes from the United States Pharmacopeia (USP) standard: [INDENT][I]Multiple-Dose Container: (see 659) A multiple-unit container for articles or preparations intended for parenteral administration only and usually containing antimicrobial preservatives. [B]The beyond-use date (BUD) for an opened or entered (e.g., needle-punctured) multiple-dose container with antimicrobial preservatives is 28 days[/B] (see Antimicrobial Effectiveness Testing 51), unless otherwise specified by the manufacturer.[/I][/INDENT] [URL]https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/gc-797-rb-notice-20200424.pdf[/URL] The USP standard is federal law. Therefore healthcare professionals might reasonably be unwilling to contradict the directive. There are no qualifiers like "should" in the standard. "[B]The beyond-use date ... [U]is[/U] 28 days...[/B]" [INDENT][I]Prescription and over-the-counter medicines available in the United States must, by [URL='https://en.wikipedia.org/wiki/United_States_Code']federal law[/URL], meet USP-NF public standards, where such standards exist.[/I][/INDENT] [URL unfurl="true"]https://en.wikipedia.org/wiki/United_States_Pharmacopeia[/URL] [URL='https://menmd.com/category/menmd-articles/multi-dose-vials-and-the-28-day-sterility-rule/']This article[/URL] is quite cautionary and explains the challenge tests required of manufacturers. [INDENT][I]Without getting into the incredibly detailed science describing these tests, it has been accepted that multi-use vials can only be used safely for 28 days after the first puncture.[/I][/INDENT] More details on Antimicrobial Effectiveness Testing here: [URL unfurl="true"]https://latam-edu.usp.org/wp-content/uploads/2021/01/USP-NF-51.pdf[/URL] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
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Testosterone No Good After 28 Days???
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