Sodium Hydroxide Solution 0.1N

BIO PHARMA GRADE / NH4154 NaOH • F.W. 40.00 g/mol. • CAS# 1310-73-2

C of As and Tech Docs

INTENDED FOR USE IN PHARMACEUTICAL GMP PROCESSES

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BIO PHARMA GRADE / NH4154

CAS #: 1310-73-2

Molecular Formula:

NaOH

Density: 1.010 g/cm3 @ 20°C

Storage Temp: Ambient

EC#: 215-185-5

UN: UN1824

Merck Index: 14,08627

ADR: 8,11

Boiling Point: ≥ 100°C

F.W.: 40.00 g/mol

Low Chloride, Low Iron, Low Endotoxin Made with USP Water for Injection (WFI)


High Purity Sodium Hydroxide 0.1N 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.


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

ANALYSIS

SPECIFICATIONS
Appearance and Color  
Clear / Colorless Liquid
Chloride (Cl)  
≤ 5 ppm
Endotoxins  
≤ 2.0 EU/mL
Heavy Metals (as Pb)  
≤ 1 ppm
Iron (Fe)  
≤ 0.5 ppm
Normality  
0.0997N – 0.1003N
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
Stability Testing Program  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Available
Enzyme Tested  
Available
Suitable for use as Excipient  
Available
Microbial / Endotoxin Tested  
Available
Manufactured in FDA Registered Facility  
Yes
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
Accelerated Stability  
Available
Type IV Drug Master File  
No
Video Conference access to BioSpectra Sites  
No
Complete access to Product Traceability  
No
Access to Supply Chain Information  
No
ICH Q7 Qualified Utilities  
No
ICH Q7 Compliant Manufactured  
No
Suitable for use as Active Ingredient  
No
Type II Drug Master File  
No
List of C of As files
NH4154-001-0520.pdf

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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)

General Product Description:

The manufacturing of Bio Pharma Grade Sodium Hydroxide NH4154 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 0.1N 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 0.1N solution, NH4154 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
  • Sodium Hydroxide 0.1N solution manufactured at BioSpectra and any raw materials used in the manufacture of Sodium Hydroxide 0.1N 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: 1.010 g/cm3 at 20°C
Solubility: Soluble in water.

GMP Compliance:

Bio Pharma Grade Sodium Hydroxide 0.1N solution, NH4154 is suitable for use as a GMP process chemical. It is manufactured in accordance with the IPEC Joint Good Manufacturing Practice Guide. This material is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.

Expiration/Retest Date:

The recommended retest period for Sodium Hydroxide 0.1N 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:

Skin Irritation: 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
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:

940L totes, 200L drums, 19L pails, 10L pails, 4x4L case and 6x1L case.