API
ICH-Q7 GMP ManufacturedActive 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 | |||
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Passes Test | |||
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Clear and Colorless | |||
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98.0-100.5% | |||
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Passes Test | |||
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10 ppm max. | |||
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Passes Test | |||
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0.6% max. | |||
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20 ppm max. | |||
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1.0% max. | |||
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0.02% max. | |||
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0.01% max. | |||
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5 ppm max. 5 ppm max. 5 ppm max. 5 ppm max. |
| Key Compliance Attributes of BioSpectra Grades | Bio Active Grade ICH Q7 Compliant Manufactured | ||
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| indicates an attribute or level of compliance which is granted or available based on the purchase of the product grade. |
| Bio Active Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient |
| LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin). LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications. |
| List of C of As files |
|---|
|
KBRO-0123-00035_KBRO-2302.pdf |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
- Elemental Impurities
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- GMO Statement
- Melamine
- Residual Solvents
- Gluten Free
- Ingredient Declaration
- Prop 65
- Stability Data Statement
- Supply Chain
- Imidazole
- TUPP Report - Stroudsburg
- Formaldehyde
- Slip Agent Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Catalyst
- Test Methods
- IRGAFOS
- Degradation and Impurity
- Stability Report
- Nitrosamine Risk Assessment
- Elemental Impurity Assessment
- Label Copy
- Certificate of Origin
KBRO-2302
CAS #: 7758-02-3
Formula:
KBr
Solubility in Water (g/L): 119
F.W.: 119.00 g/mol
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