GMP Manufactured Process Chemical
High Purity Sodium Hydroxide 5N 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: 1.020 g/cm3 at 20°C
Storage Temp: Ambient
EC#: 215-185-5
UN: UN1824
Merck Index: 14,08627
ADR: 8,11
F.W.: 40.00 g/mol
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ANALYSIS |
SPECIFICATIONS |
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Clear / Colorless Liquid | ||
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≤ 5 ppm | ||
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≤ 2.0 EU/mL | ||
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≤1 ppm | ||
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4.95-5.05N | ||
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≤ 0.5 ppm |
Printable Version
The manufacturing of Bio Pharma Grade Sodium Hydroxide NAHY-4124 is performed at BioSpectra’s Bangor, PA, US FDA registered, GMP facility and is conducted in a dedicated processing area using only dedicated equipment.
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.
Appearance: Colorless liquid.
Odor: Odorless.
Odor threshold: Not Available.
pH: ~14
Boiling range: 105°C to 140°C
Flash Point: Not flammable.
Density: 1.020 g/cm3 at 20°C
Solubility: Soluble in water.
Bio Pharma Grade Sodium Hydroxide 5N, NAHY-4124 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 5N Solution is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.
The recommended retest period for Sodium Hydroxide 5N solution is two years from the date of manufacture.
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.
Pictogram 
Signal Word: Danger
Hazard Statements
H290 - May be corrosive to metals
H314 - Causes severe skin burns and eye damage
H402 - Harmful to Aquatic Life
940L totes, 200L drums, 19L pails, 10L pails, 3.78L bottles and 6x1L case.
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.