Product Category

GMP Solution

GMP Manufactured Process Chemical

Sodium Hydroxide Solution 10N (30%), GMP Grade

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

Product Code: NAHY-4150 | Previously: NH4150

Intended For Use In Pharmaceutical GMP Processes

High Purity Sodium Hydroxide 10N 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
≤ 5 ppm
≤ 2.0 EU/mL
Heavy Metals (as Pb)  
≤ 1 ppm
≤ 2 ppm
Normality 9.9N - 10.1N
Sodium Carbonate  
≤ 0.6%
Printable Version

Product Inquiry

Please enter your first name

Please enter title

Please enter product of interest

Enter name of company

Please enter your last name

Please enter your valid email address

Enter position in company

Location of company
Please enter street address

Enter your company state

Invalid Input

Please enter city

Enter zip code

Enter Country

Enter country code

Enter phone number

Enter web address

Please select any option

If resale please fill out the following information
Enter end use customer's full name

Enter end use customer's address

Please select any option

Please select any one option

Please select any option

Invalid Input

Please select any one option

Invalid Input

Invalid Input

Please enter Estimated Release quantity in Liters or Kg

Please enter Regulatory Requirements

Please enter timeframe needed

Please enter Estimated annual demand in liters or kg

Please enter Logistics: Freight

Please enter specificatoin

Validate Recaptcha

General Product Description:

The manufacturing of Bio Pharma Grade Sodium Hydroxide NAHY-4150 is performed at BioSpectra’s Bangor, PA, USA 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 is a Clear / Colorless Liquid
  • BioSpectra certifies that all Sodium Hydroxide NAHY-4150 at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
  • Sodium Hydroxide manufactured at BioSpectra and any raw materials used in the manufacture of Sodium Hydroxide at BioSpectra are not subject to genetic modification.
  • Synonyms: NaOH Solution 10N, Sodium Hydroxide Solution 10N, Sodium Hydroxide 30% Solution, Sodium Hydrate

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 (physical state, color, etc.) Colorless liquid.
Odor Odorless.
Odor threshold Not Available
pH ~14
Melting point/freezing point -12-10°C (10-50°F)
Initial boiling point and boiling range 105-140°C (221-284°F)
Flash point: Not Flammable.
Vapor density 1.33 (air=1)
Density 1.54 g/cm3
Solubility(ies) Soluble in water.

GMP Compliance:

Bio Pharma Grade Sodium Hydroxide NAHY-4150 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 Solution is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.

Retest Date:

BioSpectra can state that Sodium Hydroxide 10N Solution, Bio Pharma Grade manufactured at BioSpectra has undergone a 36-month stability testing program. A 24-month retest date is currently assigned based on the Long-Term Stability Data. A 36-month expiry date may also be assigned for NAHY-4150 upon request.

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. Warming the product will allow for full dissolution of material.

GHS Classification:


Signal Word: Danger

Hazard Statements
    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:

Sodium Hydroxide Solution 10N (30%) is available in 940L totes, 200L drums, 19L pails, 10L pails, 3.78L bottles and 6x1L case.

Additional Packaging Information