ICH-Q7 GMP Manufactured Product
Sodium Chloride Solution (5M) Solution
Made with WFI & Multicompendial NaCl xtl, Sterile Filtered into Sterile Single Use Pkg.
ANALYSIS |
SPECIFICATIONS |
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Clear Colorless Solution | ||
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4.9-5.1M | ||
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≤ 2.5 EU/mL | ||
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Meets Requirements Meets Requirements |
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≤ 50 CFU/g ≤ 150 CFU/g |
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≤ 2 ppm ≤ 2 ppm ≤ 2 ppm ≤ 2 ppm |
Printable Version
The manufacturing of Bio Excipient Grade Sodium Chloride 5M,
NACL-3150 is performed at BioSpectra’s Bangor, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
Bio Excipient Grade Sodium Chloride 5M NACL-3150 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Sodium Chloride 5M Solution is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
Ship and Store in ambient temperature.
1025L in a BPC bag placed in a tote
American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.