Sodium Hydroxide Solution 10N (30%)

BIO PHARMA GRADE | NH4150

C of As and Tech Docs

INTENDED FOR USE IN PHARMACEUTICAL GMP PROCESSES

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BIO PHARMA GRADE / NH4150

CAS #: 1310-73-2

Molecular 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

Boiling Point: ≥ 105oC

F.W.: 40.00 g/mol

GMP SODIUM HYDROXIDE Solution 10N 30% (NaOH)  Low Chloride, Low Iron, Low Endotoxin Made with USP Water for Injection (WFI)


High Purity Sodium Hydroxide (NaOH) 10N 30% 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.


These are general specifications. BioSpectra will customize our products to meet your quality based requirements.

 
ANALYSIS SPECIFICATIONS
Appearance and Color  
Clear / Colorless Liquid
Chloride  
≤ 5 ppm
Endotoxins  
≤ 2.0 EU/mL
Heavy Metals (as Pb)  
≤ 1 ppm
Iron  
≤ 2 ppm
Normality 9.9N - 10.1N
Sodium Carbonate  
≤ 0.6%
Printable Version

Key Compliance Attributes of

BioSpectra Grades

Bio Pharma Grade IPEC

GMP

Compliant

Manufactured

Suitable for Research and Diagnostic  
Yes
Each Batch 100% Analyzed  
Yes
Management of Change  
Yes
Validated Analytical Methods  
Yes
Compendial Testing  
Yes
Trace Metals Analyzed  
Yes
Two Year Stability  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Yes
Enzyme Tested  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Suitable for use as Excipient  
Available
Microbial / Endotoxin Tested  
Available
Manufactured in FDA Registered Facility  
Available
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
Accelerated Stability  
Available

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Review the below Intended End Use Statements for each Grade and Choose the Product Grade that is most applicable to your use.


a.) Bio Pharma Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: IPEC Compliant GMP Manufactured Chemical, for use in further Manufacturing or as a Reagent for Laboratory and Research. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.


b.) Bio Excipient Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient for use in further Manufacturing. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.


c.) O Bio Active Grade INTENDED USE: Material Represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Active Pharmaceutical Ingredient for use in further Manufacturing or use in Drug Product Manufacturing. The material represented by this Grade is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item. (This statement will change depending on the status of your Drug Application in accordance with 21 CFR §201.122)

Sodium Hydroxide (NaOH) 10N 30% Solution Description:

The manufacturing of Bio Pharma Grade Sodium Hydroxide NH4150 is performed at BioSpectra’s Bangor, PA, USA FDA registered, GMP facility and is conducted in a dedicated processing area using only dedicated equipment.

  • Sodium Hydroxide is a Clear / Colorless Liquid.
  • BioSpectra certifies that all Sodium Hydroxide NH4150 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.

NaOH 10N GMP Compliance:

Bio Pharma Grade Sodium Hydroxide 10N NH4150 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: IPEC Compliant cGMP Manufactured Chemical, for use in further Manufacturing or as a Reagent for Laboratory and Research. This Grade of Sodium Hydroxide Solution is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.

NaOH 10N Expiration/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:

Skin corrosion Category 1, Serious eye damage Category 1, Acute aquatic toxicity Category 3 
H290 May be corrosive to metals 
H314 Causes severe skin burns and eye damage
H402 Harmful to aquatic life
P280 Wear protective gloves/protective clothing/eye protection/face protection. 
Inhalation May be harmful if inhaled. Material is extremely destructive to the tissue of the mucous membranes and upper respiratory tract. Causes skin burns. 
NFPA Rating and HMIS Classification:
Health: 3. Fire: 0. Reactivity: 1.

Package Sizes:

Sodium Hydroxide Solution 10N (30%) is available in 940L totes, 200L drums, 19L pails, 10L pails,4x4L case and 6x1L case.