GMP Solution
GMP Manufactured Process ChemicalSodium Hydroxide Solution 10N (30%), GMP Grade
Low Chloride, Low Iron, Made with WFI, BET Tested, GMP Manufactured
Product Code: NAHY-4150 | Previously: NH4150
Intended For Use In Pharmaceutical GMP Processes
High Purity Sodium Hydroxide 10N 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.
Product Specifications
| ANALYSIS | SPECIFICATIONS | ||
|---|---|---|---|
|
Clear / Colorless Liquid | ||
|
≤ 5 ppm | ||
|
≤ 2.0 EU/mL | ||
|
≤ 1 ppm | ||
|
≤ 2 ppm | ||
| Normality | 9.9N - 10.1N | ||
|
≤ 0.6% |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- C of As
- SDS
- Elemental Impurities
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- GMO Statement
- Melamine
- Residual Solvents
- Gluten Free
- Ingredient Declaration
- REACH
- Prop 65
- Stability Data Statement
- Supply Chain
- Imidazole
- TUPP Report - Stroudsburg
- Formaldehyde
- Slip Agent Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Catalyst
- Test Methods
- IRGAFOS
- Stability Report
- Nitrosamine Risk Assessment
- Elemental Impurity Assessment
- Label Copy
- Certificate of Origin
NAHY-4150
CAS #: 1310-73-2
Formula: NaOH
Density: 1.32-1.34 g/cm3 @ 20°C
Storage Temp: Ambient
EC#: 215-185-5
UN: 1824
Merck Index: 14,08627
ADR: 8,11
F.W.: 40.00 g/mol
General Product Description:
The manufacturing of Bio Pharma Grade Sodium Hydroxide NAHY-4150 is performed at BioSpectra’s Bangor, PA, USA 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 is a Clear / Colorless Liquid
- BioSpectra certifies that all Sodium Hydroxide NAHY-4150 at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
- Sodium Hydroxide manufactured at BioSpectra and any raw materials used in the manufacture of Sodium Hydroxide at BioSpectra are not subject to genetic modification.
- Synonyms: NaOH Solution 10N, Sodium Hydroxide Solution 10N, Sodium Hydroxide 30% Solution, Sodium Hydrate
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 (physical state, color, etc.) Colorless liquid.
Odor Odorless.
Odor threshold Not Available
pH ~14
Melting point/freezing point -12-10°C (10-50°F)
Initial boiling point and boiling range 105-140°C (221-284°F)
Flash point: Not Flammable.
Vapor density 1.33 (air=1)
Density 1.54 g/cm3
Solubility(ies) Soluble in water.
GMP Compliance:
Bio Pharma Grade Sodium Hydroxide NAHY-4150 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:
The expiration date for Sodium Hydroxide 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. 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:
Sodium Hydroxide Solution 10N (30%) is available in 940L totes, 200L drums, 19L pails, 10L pails, 3.78L bottles and 6x1L case.
Additional Packaging Information
https://www.biospectra.us/technical/packaging