Sodium Hydroxide Solution 1N GMP

GMP Solution

IPEC GMP Manufactured Process Chemical

Sodium Hydroxide 1N Solution

GMP
Product Code: NAHY-4153

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-4153

Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes.

High-purity Sodium Hydroxide 1N Solution is suitable for use in critical pharmaceutical processes both upstream and downstream. This product is manufactured utilizing a proprietary, validated GMP process that utilizes multiple manufacturing and purification steps to achieve high purity results without the use of pellets.

CAS #: 1310-73-2
Formula: NaOH
F.W.: 40.00 g/mol
Density: 1.02
EC#: 215-185-5

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance and Color

Clear, Colorless Solution

Chloride

< = 5 ppm

Endotoxin

< = 2.0 EU/mL

Trace Metals

Iron (Fe)

Lead (Pb)

< = 0.5 ppm

< = 1 ppm

Normality

0.9N – 1.1N

Printable Version

Key Product Features:

The manufacturing of Sodium Hydroxide 1N Solution is performed at BioSpectra’s Bangor, PA facility.
Appears as a clear, colorless solution
Manufactured in accordance with IPEC
Manufactured in an enzyme free, hormone free, and animal free environment
Contains no known major food allergens (as defined by FDA and WHO)
The final product and its raw materials are not derived from nor come into contact with animal parts, animal products, and/or animal byproducts or derivatives.
Is not subject to genetic modification
Synonyms: NaOH Solution 1N; Caustic soda; lye

Shelf-Life Policy:

Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Storage & Shipping:

Refer to SDS.

Package Sizes:

200L drum, 1,000L IBC, 10L carboy, case of 4x4L bottles and case of 6x1L bottles

Note that 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.