General Product Description:
- The manufacturing of Bio Excipient Grade UREA-3250 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
- Urea is a White Crystalline powder.
- Molecular Formula: CH4N2O
- Molecular Weight: 60.06 g/mol.
- CAS #: 57-13-6
- There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
- BioSpectra certifies that all Urea UREA-3250 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
- Urea manufactured at BioSpectra and any raw materials used in the manufacture of Urea at BioSpectra are not subject to genetic modification.
- Synonyms: Urea, Carbamide, Carbonyldiamide
Product Statements:
RESIDUAL SOLVENTS: Based on the manufacturing process and the controlled handling, storage and analysis of this product, this product complies with the requirement and specifications listed in the current USP method <467> Tables 1, 2, 3, or 4.
GMP Compliance:
Bio Excipient Grade Urea, UREA-3250 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Urea is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
Retest Date:
The recommended retest period for Urea is two years from the date of manufacture.
Storage and Shipping Conditions:
- Ship and Store between 15 ̊ and 30 ̊C.
- Store in clean and dry area.
- Store in the original container.
Package Sizes:
10kg and 25kg pails and 50kg drums.
