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GMP Solution / 

GMP Manufactured Process Chemical   
Sodium Hydroxide 8N (25%) Solution, Low Chloride, GMP Grade

Product Code: NAHY-4151

CAS #: 1310-73-2
Formula: NaOH
Density: 1.280 g/cm3 @ 20oC
Storage Temp: Ambient
EC#: 215-185-5
UN: UN1824
Merck Index: 14,08627
ADR: 8,11 | F.W.: 40.00 g/mol

Minimum Order Quantity: 4000-liters Lead Time (if no stock): 1-2 months

Package Sizes:

6x1L case, 4x1gal (3.78L each) case (15L total), 10L 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.

Specifications
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Product Code: NAHY-4151 | Previously: NH4151
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 (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.
    H318 – Causes serious eye damage.
    H402 – Harmful to aquatic life.

Package Sizes:

  • 6x1L case, 4x1gal (3.78L each) case (15L total), 10L 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.