Potassium Bromide, USP API

API

ICH Q7 GMP Manufactured Active Drug Ingredient

Potassium Bromide

USP, GMP, API (Large Batch - Up to 1000kg)
Product Code: KBRO-2302

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

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

Product Code: KBRO-2302

Potassium Bromide is used as an active substance in veterinary medicine as an anti-seizure medication.

This Potassium Bromide product code is the blend of multiple production batches to provide the end-user with a larger blended, uniform lot size. 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.

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

98.0 - 100.5%

Bromates

Passes Test

Identity

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

Printable Version

Key Product Features:

The manufacturing of Potassium Bromide KBRO-2302 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.