ICH-Q7 GMP Manufactured Product
Sodium Chloride Solution (5M) Solution
Made with WFI & Multicompendial NaCl xtl, Sterile Filtered into Sterile Single Use Pkg.
BioSpectra’s 5M GMP NaCl is manufactured under ISO Class 6 environmental controls to meet stringent quality attributes for in-process and downstream use in BioPharma applications. The product is made with multicompendial salt and water for injection. It is sterile filtered into custom, sterile, single use biocompatible packaging. This product and process is fully validated under FDA guidelines.
CAS #: 7647-14-5
Formula: NaCl
Sol. In H2O (g/L): 360 g/L (25 ºC)
F.W.: 58.44 g/mol
Product Specifications
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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
General Product Description:
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.
- Molecular Formula: NaCl
- Molecular Weight: 58.44 g/mol.
- CAS#: 7647-14-5
- Sodium Chloride 5M is a clear colorless solution.
- There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
- BioSpectra certifies that all Sodium Chloride 5M, NACL-3150 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
- Sodium Chloride 5M solution manufactured at BioSpectra and any raw materials used in the manufacture of Sodium Chloride 5M at BioSpectra are not subject to genetic modification.
- Manufactured with WFI water.
GMP Compliance:
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.
Storage and Shipping Conditions:
Ship and Store in ambient temperature.
Package Sizes:
1025L in a BPC bag placed in a tote
Bulk GMP Fine Chemicals exclusively manufactured in North America
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.