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GemPure™ Plus Water for Injection (WFI) Quality Water (USP/EP/JP Grade)

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GemPure™ Plus Water for Injection (WFI) Quality Water (USP/EP/JP Grade)

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GemPure™ Plus Water for Injection (WFI) Quality Water (USP/EP/JP Grade) GemPure™ Plus Water for Injection (WFI) Quality Water (USP/EP/JP Grade) optimizes your upstream and downstream bioprocess workflows and productivity from development to commercial production and meets specifications of monographs for the United States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP).

  • Multicompendial, meeting testing specifications for USP, EP, and JP monographs.
  • Manufactured in an ISO13485:2016 and 21CFR820 compliant facility.
  • Available in 4L, 20L, 200L, as well as custom sizes to suit your needs. For further manufacturing or research use only. Not for direct Therapeutic use.
Test NameTest ReferenceSpecification
Appearance VisualClear and Colorless Liquid
 TOC (Before Packaging)USP<643>< 500 ppb
 TOC (Packaged)USP<643>< 8000 ppb
Conductivity (Before Packaging)USP<644>< 1.3 µS/cm
Conductivity (After Packaging)USP<644>≤ 5 µS/cm
pHUSP<791>4.0 - 7.0
Endotoxin USP<85>< 0.25
SterilityUSP<71>No Growth
Particulate MatterUSP<788>, EP (2.9.19)< 3 particles per mL that are ≥ 25 µm in size
Particulate MatterUSP<788>, EP (2.9.19)< 25 particles per mL that are ≥ 10 µm in size
Oxidizable SubstancesUSP/EPThe pink color does not completely disappear.
AmmoniumEP≤0.2 ppm
Residue on EvaporationEP≤3 mg (0.003%)
Acidity or AlkalinityEPNo change in appearance
ChloridesEPNo change in appearance.
NitratesEP≤0.2 ppm
SulfatesEPNo change in appearance.
Calcium and MagnesiumEPBlue Color Produced
Heavy MetalsEP (2.4.27)≤0.1 ppm
PurityJPPass
Extractable VolumeJP<6.05>Volume is Not Less than the Nominal Volume
Foreign Insoluble MatterJP<6.06>See above Particulate Matter
Expiration 24 months

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Product Detail
Thomas No.
CHM03W484
Mfr. No.
901-002-4X4
Description
GemPure™ Plus Water for Injection (WFI) Quality Water (USP/EP/JP Grade), 4L
list price/quantitytotal
$0.00
Thomas No.
CHM03W485
Mfr. No.
901-002-021
Description
GemPure™ Plus Water for Injection (WFI) Quality Water (USP/EP/JP Grade), 20L
list price/quantitytotal
$0.00
Thomas No.
CHM03W486
Mfr. No.
901-002-203
Description
GemPure™ Plus Water for Injection (WFI) Quality Water (USP/EP/JP Grade), 200L
list price/quantitytotal
$0.00
$0.00 (0 Items)
Product is restricted and can only be purchased by customers with a web profile linked to a Thomas Business Account - Click here to login or create your web profile. If you do not have a Thomas Business Account, please Contact Us and someone will respond with details on how to apply for a business account with us.

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