GMP Manufactured Process Chemical
Sodium Hydroxide (25%) Solution
High Purity Sodium Hydroxide 25% solution 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.
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
Product Specifications
|
ANALYSIS |
SPECIFICATIONS |
||
|---|---|---|---|
|
Clear / Colorless Liquid | ||
|
24.5 – 25.5% | ||
|
≤ 5 ppm | ||
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≤ 2.0 EU/mL | ||
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≤ 1 ppm | ||
|
≤ 0.500 ppm |
Printable Version
General Product Description:
The manufacturing of Bio Pharma Grade Sodium Hydroxide 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 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 25% solution manufactured at BioSpectra and any raw materials used in the manufacture of Sodium Hydroxide 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:
940L totes, 200L drums, 19L pails, 10L pails, 3.78L bottles and 6x1L case.
Bulk GMP Fine Chemicals exclusively manufactured in North America
American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.