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Intended For Use In Pharmaceutical GMP Processes 

• High Purity Sodium Hydroxide 8N 25% solution is intended for use in critical pharmaceutical processes, both upstream and downstream. This product is manufactured utilizing a proprietary, validated GMP system that utilizes multiple manufacturing and purification steps to achieve high purity results without the use of pellets.

General Product Description:

The manufacturing of Bio Pharma Grade Sodium Hydroxide 8N 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 8N 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 8N 25% solution manufactured at BioSpectra and any raw materials used in the manufacture of Sodium Hydroxide 8N 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:

• 6x1L case, 4x1gal (3.78L each) case (15L total), 10L poly pail, 19L poly pail, 200L poly drum, IBC's - custom filled: 940L, 1000L, 1100L.

  Please note: 200L and IBC packages are not permitted to ship by air.