Sodium Hydroxide Solution 8N 25% GMP

GMP Solution

GMP Manufactured Process Chemical

Sodium Hydroxide 8N (25%) Solution

GMP Grade
Product Code: NAHY-4151

Minimum Order Quantity: 1000-liters Lead Time (if no stock): 1-2 months

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

Product Code: NAHY-4151 | Previously: NH4151

Intended For Use In Pharmaceutical GMP Processes

High Purity Sodium Hydroxide 8N 25% solution is intended for use in critical pharmaceutical processes, both upstream and downstream. This product is manufactured utilizing a proprietary, 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 @ 20^oC
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

Appearance and Color

Clear / Colorless Liquid

Assay (NaOH)

24.5 – 25.5%

Chloride (Cl)

≤ 5 ppm

Endotoxins

≤ 2.0 EU/mL

Heavy Metals (as Pb)

≤ 1 ppm

Iron (Fe)

≤ 0.500 ppm

Printable Version

General Product Description:

The manufacturing of Bio Pharma Grade Sodium Hydroxide 8N 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 8N 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 8N 25% solution manufactured at BioSpectra and any raw materials used in the manufacture of Sodium Hydroxide 8N 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:

6x1L case, 4x1gal (3.78L each) case (15L total), 10L poly pail, 19L poly pail, 200L poly drum, IBC's - custom filled: 940L, 1000L, 1100L.

Please note: 200L and IBC packages are not permitted to ship by air.

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.