General Product Description:
- The manufacturing of Potassium Bromide KBRO-2220 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-2220 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-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.
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.
