Sodium Chloride Solution 5M GMP Excipient

GMP Solution

ICH Q7 GMP Manufactured Product

Sodium Chloride 5M Solution

BET*, GMP, Excipient
Product Code: NACL-3150

Made with WFI & Multicompendial NaCl Crystal, Sterile Filtered into Sterile Single Use Pkg.

*Bioburden and Endotoxin Tested

Minimum Order Quantity: 7175L
Lead Time (if no stock): 3-6 months

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Product Code: NACL-3150

Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products.

BioSpectra’s Sodium Chloride 5M Solution meets 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 single use biocompatible packaging. This product and process is fully validated under FDA guidelines.

CAS #: 7647-14-5
Formula: NaCl
F.W.: 58.44 g/mol
Solubility at 20°C: 317 g/L

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance and Color

Clear Colorless Solution

Molarity

4.9 - 5.1M

Endotoxin

< = 2.5 EU/mL

Identification

Chloride

Sodium

Passes Test

Microbial Content

TAMC

TYMC

< = 50 CFU/g

< = 150 CFU/g

Trace Metals

Arsenic (As)

Copper (Cu)

Iron (Fe)

Lead (Pb

< = 2 ppm

Printable Version

Key Product Features:

The manufacturing of Sodium Chloride 5M Solution is performed at BioSpectra's Bangor, PA facility.
Appears as a clear, colorless solution
Manufactured in accordance with ICH Q7
Manufactured in an enzyme free, hormone free, and animal free environment
Contains no known major food allergens (as defined by FDA and WHO)
The final product and its raw materials are not derived from nor come into contact with animal parts, animal products, and/or animal byproducts or derivatives.
Is not subject to genetic modification

Shelf-Life Policy:

Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Storage & Shipping:

Refer to SDS.

Package Sizes:

1,000L IBC – Sterile, Single-Use Container
200L Drum – Sterile, Single-Use Container

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.