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API

ICH Q7 GMP Manufactured Active Ingredient

Potassium Bromide

USP, EP, GMP, API
Product Code: KBRO-2220

Minimum Order Quantity: 100kg
Lead Time (if no stock): 3-months

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QUANTITY
Product Code: KBRO-2220
Potassium Bromide is used as an active substance in veterinary medicine as an anti-seizure medication.

Bio Active Grade Potassium Bromide KBRO-2220 is suitable for use as a non-Sterile Active Pharmaceutical Ingredient manufactured in accordance with the ICH Q7 Good Manufacturing Practice Guide. This grade of Potassium Bromide is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item.

CAS #: 7758-02-3
Formula: KBr
F.W.: 119.00 g/mol
Solubility at 25°C: 678 g/L

Product Specifications

ANALYSIS SPECIFICATIONS
Acidity or Alkalinity  
Passes Test
Appearance of Solution  
Clear and Colorless
Assay  
98.5 - 100.5%
Bromates  
Passes Test
Identification

A

B

Passes Test

Passes Test

Iodides  
Passes Test
Limit of Chlorine  
< = 0.6%
Loss on Drying  
< = 1.0%
Magnesium and Alkaline Earth-Metals  
< = 0.02%
Sulfate  
< = 100 ppm
Trace Metals

Arsenic (As)

Copper (Cu)

Iron (Fe)

Lead (Pb)

< = 5 ppm

< = 5 ppm

< = 5 ppm

< = 5 ppm

 

Printable Version

Key Product Features:

  • The manufacturing of Potassium Bromide, KBRO-2220 is performed at BioSpectra’s Bangor, PA facility.
  • Appears as a white crystalline solid
  • Manufactured in accordance with ICH Q7
  • 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: Bromide Salt of Potassium

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:

10kg, 25kg, and 50kg

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.