General Product Description:
The manufacturing of Bio Excipient Grade Sodium Hydroxide NH3153 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 1N 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 1N solution, NH3153 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
- Sodium Hydroxide 1N solution manufactured at BioSpectra and any raw materials used in the manufacture of Sodium Hydroxide 1N 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 threshold: Not Available.
Boiling range: 100°C to 140°C
Flash Point: Not flammable.
Density: 1.020 g/cm 3 at 20°C
Solubility: Soluble in water.
Bio Excipient Grade Sodium Hydroxide Solution 1N, NH3153 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Sodium Hydroxide Solution 1N is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
The recommended retest period for Sodium Hydroxide 1N 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. Warming the product will allow for full dissolution of material.
Skin Irritation: Category 1
Serious Eye Damage: Category 1
Acute Aquatic Toxicity: Category 3
H290 May be corrosive to metals
H314 Causes severe skin burns and eye damage
H402 Harmful to aquatic life
P280 Wear protective gloves/protective clothing/eye
May be harmful if inhaled. Material is extremely destructive
to the tissue of the mucous membranes and upper
respiratory tract. Causes skin burns.
NFPA Rating and HMIS Classification:
Health: 3. Fire: 0. Reactivity: 1.
940L totes, 200L drums, 19L pails, 10L pails, 4x4L case and 6x1L case.