GMP Manufactured Process Chemical
ANALYSIS |
SPECIFICATIONS |
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---|---|---|---|
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Clear / Colorless Liquid | ||
Chloride | ≤ 5 ppm | ||
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≤ 2.0 EU/mL | ||
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≤1 ppm | ||
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≤ 0.5 ppm | ||
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0.480N – 0.520N |
Printable Version
The manufacturing of Bio Pharma Grade Sodium Hydroxide NAHY-4152 is performed at BioSpectra’s Bangor, PA, US FDA registered, GMP facility and is conducted in a dedicated processing area using only dedicated equipment.
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.
Appearance: Colorless liquid.
Odor: Odorless.
Odor threshold: Not Available.
pH: ~14
Boiling range: 100°C to 140°C
Flash Point: Not flammable.
Density: 1.020 g/cm3 at 20°C
Solubility: Soluble in water.
Bio Pharma Grade Sodium Hydroxide 0.5N, NAHY-4152 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 0.5N Solution is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.
The recommended retest period for Sodium Hydroxide 0.5N solution is two years from the date of manufacture.
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.
Hazard Pictogram (GHS & CLP)
Signal Word (GHS & CLP): Danger
Hazard Statements (GHS &CLP)
H290 May be corrosive to metals
H314 Causes severe skin burns and eye damage
940L totes, 200L drums, 19L pails, 10L pails, 3.78L bottles and 6x1L case.
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.