| TEST |
SPECIFICATION |
| GMP Manufactured Product |
| Meets U.S.P. Requirements |
| Identification A |
Passes Test |
| Identification B |
Passes Test |
| Melting Range |
132 - 135 ?C. |
| Residue on Ignition |
max. 0.1 % |
| Alcohol Insoluble Matter |
max. 0.04 % |
| Chloride (Cl) |
max. 0.007 % |
| Sulfate (SO4) |
max. 0.010 % |
| Heavy Metals (as Pb) |
max. 0.002 % |
| Assay (NH2CONH2) |
99.0 - 100.5 % |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |
| Bulk Pharmaceutical Chemical |
| CAUTION: For manufacturing, processing or repacking. |
| Manufactured exclusively for Avantor Performance Materials, Inc., by BioSpectra, Inc., Stroudsburg, PA |
| For a Certificate of Lot Analysis, visit www.avantormaterials.com |
| Preserve in tight containers. Store at 25?C, excursions permitted between15?C and 30?C. |