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
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.
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.
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.
10kg and 25kg pails and 50kg drums.
Additional Packaging Information