Product Category

GMP Solution

ICH-Q7 GMP Manufactured Product

Sodium Hydroxide 1.0N Soln.
GMP, LBLE, Excipient Grade

Low Chloride, Low Iron, BET tested, Made with WFI,
Sterile Filtered into Sterile Single Use Pkg.

Product Code: NAHY-3153 | Previously: NH3153

Intended Use Statement


High Purity Sodium Hydroxide 1.0N solution is intended for use in critical pharmaceutical processes, both upstream and downstream. This product is manufactured utilizing a proprietary, fully dedicated, validated GMP system that utilizes multiple manufacturing and purification steps to achieve high purity results without the use of pellets.

Product Specifications

ANALYSIS SPECIFICATIONS
Appearance and Color  
Clear / Colorless Liquid
Chloride  
≤ 5 ppm
Endotoxins  
≤ 2.0 EU/mL
Heavy Metals (as Pb)  
≤ 1 ppm
Iron (Fe)  
≤ 0.5 ppm
Normality 0.9N – 1.1N
Sterile Filtered  
StyLux ST 0.2 Ultra Cap HD Filter from Meissner
Sterile Filtered in Sterile BPC  
Verified
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH-Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes-image
Each Batch 100% Analyzed  
Yes-image
Management of Change  
Yes-image
Validated Analytical Methods  
Yes-image
Compendial Testing  
Yes-image
Trace Metals Analyzed  
Yes-image
Stability Testing Program  
Yes-image
BioSpectra Supply Chain Audit Trail  
Yes-image
Product Origin Statement  
Yes-image
Customer Quality Audits  
Yes-image
Validated Manufacturing Process  
Yes-image
US Manufactured at BioSpectra  
Yes-image
Customized Additional Specifications  
Yes-image
Multi-Compendial Testing  
Yes-image
Low Bioburden Low Endotoxin (LBLE)  
Yes-image
Enzyme Tested  
Yes-image
Suitable for use as Excipient  
Yes-image
Microbial / Endotoxin Tested  
Yes-image
Manufactured in FDA Registered Facility  
Yes-image
Customized Manufacturing Schedule  
Yes-image
Custom Regulatory Packet  
Yes-image
Accelerated Stability  
Yes-image
Video Conference access to BioSpectra Sites  
Yes-image
Complete access to Product Traceability  
Yes-image
Access to Supply Chain Information  
Yes-image
ICH-Q7 Qualified Utilities  
Yes-image
ICH-Q7 Compliant Manufactured  
Yes-image
Type II Drug Master File  
Yes-image

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient 
LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin).
LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications.

 

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COAs and Tech Docs

Product-image
formula-image

NAHY-3153

CAS #: 1310-73-2

Formula: NaOH

Density: 1.020 g/cm3 at 20°C

Storage Temp: Ambient

EC#: 215-185-5

UN: UN1824

Merck Index: 14,08627

ADR: 8,11

F.W.: 40.00 g/mol

General Product Description:

The manufacturing of Bio Excipient Grade Sodium Hydroxide NAHY-3153 is performed at BioSpectra’s Bangor, PA, US FDA registered, GMP facility and is conducted in a dedicated processing area using only dedicated equipment.

  • Molecular Formula: NaOH
  • Molecular Weight: 40.00 g/mol
  • CAS #: 1310-73-2
  • Sodium Hydroxide 1N solution is a clear, colorless liquid.
  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
  • BioSpectra certifies that all Sodium Hydroxide 1N solution, NAHY-3153 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
  • Sodium Hydroxide 1N solution manufactured at BioSpectra and any raw materials used in the manufacture of Sodium Hydroxide 1N solution at BioSpectra are not subject to genetic modification.

Stability and Reactivity:

Chemical Stability: Stable.

Possibility of Hazardous Reactions: Will not occur.

Incompatible Materials: Acids, organic materials, chlorinated solvents, aluminum, phosphorus, zinc, tin.

Hazardous Decomposition Products: Sodium oxides.


Physical and Chemical Properties:

Appearance: Colorless liquid.
Odor: Odorless.
Odor threshold: Not Available.
pH: ~14
Boiling range: 100°C to 140°C
Flash Point: Not flammable.
Density: 1.020 g/cm3 at 20°C
Solubility: Soluble in water.

GMP Compliance:

Bio Excipient Grade Sodium Hydroxide Solution 1N, NAHY-3153 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Sodium Hydroxide Solution 1N is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Retest Date:

The recommended retest period for Sodium Hydroxide 1N solution is two years from the date of manufacture.

Storage and Shipping Conditions:

Ship and store in ambient temperature, there is no impact to the product within ambient conditions of 10-40°C. Store in a clean and dry area. Store in the original container. Material will freeze at slightly lower temperatures. Keep above 16°C to prevent freezing. Warming the product will allow for full dissolution of material.

GHS Classification:

Hazard Pictogram (GHS & CLP) 

Signal Word (GHS & CLP): Danger

Hazard Statements (GHS & CLP)
    H290 May be corrosive to metals
    H314 Causes severe skin burns and eye damage

Package Sizes:

940L totes, 200L drums, 19L pails, 10L pails, 3.78L bottles and 6x1L case.

Additional Packaging Information

https://www.biospectra.us/technical/packaging