Product Category

API

ICH-Q7 GMP Manufactured
Active Drug Substance

POTASSIUM BROMIDE,
API, USP Grade (Blend Batch)

Product Code: KBRO-2302

Intended For Use As An Active Pharmaceutical Ingredient


Potassium Bromide – Blend Batch, is the product code for the blend of multiple production batches to provide the end-user with a larger blended, uniform Lot size. Potassium Bromide is used as an active substance in veterinary medicine as an anti-seizure medication.

Product Specifications

ANALYSIS SPECIFICATIONS
Acidity or Alkalinity  
Passes Test
Appearance of Solution  
Clear and Colorless
Assay  
98.0-100.5%
Bromates  
Passes Test
Heavy Metals  
10 ppm max.
Identity  A
B
Passes Test
Passes Test
Iodides  
Passes Test
Limit of Chlorine  
0.6% max.
Limit of Iron  
20 ppm max.
Loss on Drying  
1.0% max.
Magnesium and Alkaline Earth-Metals  
0.02% max.
Sulfates  
0.01% max.
Trace Metals Arsenic (As)
Copper (Cu)
Iron (Fe)
Lead (Pb)
5 ppm max.
5 ppm max.
5 ppm max.
5 ppm max.
Printable Version
List of C of As files
KBRO-0123-00035_KBRO-2302.pdf

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General Product Description:

  • The manufacturing of Potassium Bromide KBRO-2302 is performed at BioSpectra’s Bangor, PA facility and utilizes multiuse equipment. Equipment used in the maunfacturing of Potassium Bromide Bio Active grade is cleaned in accordance with BioSpectra’s Process Cleaning Validation Master Plan.
  • Potassium Bromide is a White Crystalline product.
  • Molecular Formula: KBr
  • Molecular Weight: 119.00 g/mol.
  • CAS Number: 7758-02-3.
  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
  • BioSpectra certifies that all Potassium Bromide KBRO-2302 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
  • Potassium Bromide manufactured at BioSpectra and any raw materials used in the manufacture of Potassium Bromide at BioSpectra are not subject to genetic modification.
  • Synonymns: Bromide Salt of Potassium, Kalii bromidum.

 



GMP Compliance:

Bio Active Grade Potassium Bromide KBRO-2302 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.

Retest Date:

The recommended retest period for Potassium Bromide is two years from the date of manufacture.

Storage and Shipping Conditions:

  • Ship and Store between 15°C and 30°C.
  • Store in a clean and dry area.
  • Store in the original container.

Package Sizes:

10kg, 25kg and 50kg pails.

Additional Packaging Information

https://www.biospectra.us/technical/packaging