GMP Manufactured Process Chemical
Sodium Hydroxide (10N) Solution
High Purity Sodium Hydroxide 10N 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: 1.33 g/cm3 @ 20°C
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 |
||
|---|---|---|---|
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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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≤ 2 ppm | ||
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9.9N – 10.1N | ||
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≤ 0.2% |
Printable Version
General Product Description:
The manufacturing of Low Carbonate Bio Pharma Grade Sodium Hydroxide, NAHY-4155 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 10N 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 10N solution, NAHY-4155 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
- Sodium Hydroxide 10N solution manufactured at BioSpectra and any raw materials used in the manufacture of Sodium Hydroxide 10N 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: 105°C to 140°C
Flash Point: Not flammable.
Density: 1.33 g/cm3 @ 20°C
Solubility: Soluble in water.
GMP Compliance:
Bio Pharma Grade Sodium Hydroxide NAHY-4155 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.
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:
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:
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.