ICH-Q7 GMP Manufactured Product
Sodium Hydroxide (0.5N) Solution
High Purity Sodium Hydroxide 0.5N 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
Product Specifications
| ANALYSIS | SPECIFICATIONS | ||
|---|---|---|---|
|
Clear / Colorless Liquid | ||
|
≤ 5 ppm | ||
|
≤ 2.0 EU/mL | ||
|
≤ 1 ppm | ||
|
≤ 0.5 ppm | ||
| Normality | 0.480N – 0.520N | ||
|
StyLux ST 0.2 Ultra Cap HD Filter from Meissner | ||
|
Verified |
Printable Version
General Product Description:
The manufacturing of Bio Excipient Grade Sodium Hydroxide NAHY-3150 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 0.5N 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 0.5N solution,
NAHY-3150 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts. - Sodium Hydroxide 0.5N solution manufactured at BioSpectra and any raw materials used in the manufacture of Sodium Hydroxide 0.5N 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: 100°C to 140°C
Flash Point: Not flammable.
Density: 1.020 g/cm3 at 20°C
Solubility: Soluble in water.
GMP Compliance:
Bio Excipient Grade Sodium Hydroxide Solution 0.5N, NAHY-3150 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 0.5N is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
Retest Date:
The recommended retest period for Sodium Hydroxide 0.5N 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 (GHS & CLP) 
Signal Word (GHS & CLP): Danger
Hazard Statements (GHS & CLP)
H290 - May be corrosive to metals.
H314 - Causes severe skin burns and eye damage.
Package Sizes:
200-Liter SSU-BPC
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.