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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, 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 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:

Pictograms  

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 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.