Product Category

GMP Solution

GMP Manufactured Process Chemical

Sodium Hydroxide Solution 25%
GMP Grade

Low Chloride, Low Iron, Made with WFI, BET Tested, GMP Manufactured

Product Code: NAHY-4151 | Previously: NH4151

Intended For Use In Pharmaceutical GMP Processes

High Purity Sodium Hydroxide 25% 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



Appearance and Color  
Clear / Colorless Liquid
Assay (NaOH)  
24.5 – 25.5%
Chloride (Cl)  
≤ 5 ppm
≤ 2.0 EU/mL
Heavy Metals (as Pb)  
≤ 1 ppm
Iron (Fe)  
≤ 0.500 ppm
Printable Version
List of C of As files

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General Product Description:

The manufacturing of Bio Pharma Grade Sodium Hydroxide NAHY-4151 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 25% 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 25% solution, NAHY-4151 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
  • Sodium Hydroxide 25% solution manufactured at BioSpectra and any raw materials used in the manufacture of Sodium Hydroxide 25% 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: 112°C to 140°C
Flash Point: Not flammable.
Density: 1.280 g/cm3 at 20°C
Solubility: Soluble in water.

GMP Compliance:

Bio Pharma Grade Sodium Hydroxide 25%, NAHY-4151 is suitable for use as a process chemical. It is manufactured in accordance with the IPEC-PQG Joint Good Manufacturing Practice Guide. This grade of Sodium Hydroxide 25% Solution is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.

Retest Date:

The recommended retest period for Sodium Hydroxide 25% 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  

Signal Word: Danger

Hazard Statements (GHS &CLP)
    H290 - May be corrosive to metals.
    H314 - Causes severe skin burns and eye damage.
    H318 - Causes serious eye damage.
    H402 - Harmful to aquatic life.

Package Sizes:

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

Additional Packaging Information