Safer injection guide: Difference between revisions
>David Hedlund →Sterile water for injection: copied a table `Pharmacopoeia specifications for water for injection` from https://en.wikipedia.org/wiki/Ultrapure_water#Applications_in_pharmaceutical_industry |
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! Properties !! | ! Properties !! European Pharmacopoeia (Ph.Eur.)<ref>{{cite book|title=European Pharmacopoeia|date=2013|publisher=Council of Europe|location=Strasbourg, France|isbn=978-92-871-7531-1|pages=3555–3558|edition=8|language=English|chapter=Water for injections}}</ref> !! United States Pharmacopeia (USP)<ref>{{cite book|title=United States Pharmacopeia and the National Formulary (USP-NF)|date=October 2014|publisher=U.S. Pharmacopeial Convention|location=Rockville, MD, USA|page=5805|edition=USP38–NF33|chapter=USP Monographs: Water for Injection}}</ref> | ||
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| Conductivity<ref group=upper-alpha>If in-line conductivity exceeds values additional testing is required before a conclusion can be made. Refer to the respective pharmacopoeia for details.</ref> || <1.3 μS/cm at 25 °C||<1.3 μS/cm at 25 °C | | Conductivity<ref group=upper-alpha>If in-line conductivity exceeds values additional testing is required before a conclusion can be made. Refer to the respective pharmacopoeia for details.</ref> || <1.3 μS/cm at 25 °C||<1.3 μS/cm at 25 °C | ||
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| | | Total organic carbon (TOC) || <0.5 mg/L || <0.50 mg/L | ||
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| Bacteria (guideline) || <10 | | Bacteria (guideline) || <10 {{abbr|CFU|colony forming units}}/100 mL || <10 {{abbr|CFU|colony forming units}}/100 mL | ||
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| Endotoxin || <0.25 IU/mL || <0.25 EU/mL <ref group=upper-alpha>One USP Endotoxin Unit (EU) is equal to one International Unit (IU) of endotoxin</ref> | | Endotoxin || <0.25 IU/mL || <0.25 EU/mL <ref group=upper-alpha>One USP Endotoxin Unit (EU) is equal to one International Unit (IU) of endotoxin</ref> |