GMP Sodium Chloride 5M Solution

EXCIPIENT GRADE | NC3150

C of As and Tech Docs

INTENDED FOR USE AS AN EXCIPIENT

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formula-image

EXCIPIENT GRADE | NC3150

CAS #: 647-14-5

Molecular Formula:

NaCl

Solubility in Water (g/L): 360 g/L (25 ºC)

F.W.: 58.44 g/mol

Sterile Filtered, Multicompendial Salt, WFI, Sterile Single Use Package


BioSpectra’s Sodium Chloride Solution 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.


These are general specifications. BioSpectra will customize our products to meet your quality-based requirements.

 

ANALYSIS

SPECIFICATIONS

Appearance and Color  
Clear Colorless Solution
Assay  
4.9-5.1M
Endotoxin  
≤ 2.5 EU/mL
Identification

Chloride USP

Sodium USP

Meets Requirements

Meets Requirements

Microbial Content

TAMC

TYMC

≤ 50 CFU/g

≤ 150 CFU/g

Trace Metals

Arsenic (As)

Copper (Cu)

Iron (Fe)

Lead (Pb 

≤ 2 ppm

≤ 2 ppm

≤ 2 ppm

≤ 2 ppm

Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Excipient ICH Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes
Each Batch 100% Analyzed  
Yes
Management of Change  
Yes
Validated Analytical Methods  
Yes
Compendial Testing  
Yes
Trace Metals Analyzed  
Yes
Stability Testing Program  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Available
Enzyme Tested  
Available
Suitable for use as Excipient  
Yes
Microbial / Endotoxin Tested  
Yes
Manufactured in FDA Registered Facility  
Yes
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Yes
Accelerated Stability  
Available
Type IV Drug Master File  
Available
Video Conference access to BioSpectra Sites  
Available
Complete access to Product Traceability  
Available
Access to Supply Chain Information  
Yes
ICH Q7 Qualified Utilities  
Yes
ICH Q7 Compliant Manufactured  
Yes
Suitable for use as Active Ingredient  
No
Type II Drug Master File  
No

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Review the below Intended End Use Statements for each Grade and Choose the Product Grade that is most applicable to your use.


a.) Bio Pharma Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: IPEC Compliant GMP Manufactured Chemical, for use in further Manufacturing or as a Reagent for Laboratory and Research. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.


b.) Bio Excipient Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient for use in further Manufacturing. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.


c.) O Bio Active Grade INTENDED USE: Material Represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Active Pharmaceutical Ingredient for use in further Manufacturing or use in Drug Product Manufacturing. The material represented by this Grade is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item. (This statement will change depending on the status of your Drug Application in accordance with 21 CFR §201.122)

General Product Description:

The manufacturing of Bio Excipient Grade Sodium Chloride Solution 5M, NC3150 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, NC3150 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 solution, NC3150 is suitable for use as an excipient. It is manufactured in accordance with the ICH Q7 Good Manufacturing Practice Guide. Bio Excipient Grade Sodium Chloride 5M solution, NC3150 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