| TEST |
SPECIFICATION |
| GMP Manufactured Product |
| Meets B.P. Chemical Specifications |
| Meets E.P. Chemical Specifications |
| Meets JPC (1997) Chemical Specifications |
| Meets U.S.P Requirements |
| CAUTION: For Manufacturing, processing or repackaging |
| Bulk Pharmaceutical Chemical |
| USP- Assay (C4H11NO3) |
99.0 - 101.0% |
| USP- Identification A |
Passes Test |
| USP- Identification B |
Passes Test |
| USP- Identification C |
Passes Test |
| USP- pH (1 in 20) |
10.0 - 11.5 |
| USP- Loss on Drying |
<= 1.0% |
| USP- Residue on Ignition |
<= 0.1% |
| USP- Melting Range(Lower) |
168 - 172°C |
| USP- Melting Range(Upper) |
168 - 172°C |
| EP/BP- Assay (C4H11NO3) (dried basis) |
99.0 - 100.5% |
| EP/BP- Identification B |
Passes Test |
| EP/BP- Identification C |
Passes Test |
| EP/BP- Appearance of Solution |
Passes Test |
| EP/BP- pH |
10.0 - 11.5 |
| EP/BP- Related Substances |
<= 1.0% |
| EP/BP- Chloride (Cl) |
| EP/BP- Iron (Fe) |
<= 10 ppm |
| EP/BP- Loss on Drying at 105°C |
<= 0.5% |
| EP/BP- Ash (sulfated) |
<= 0.1% |
| JPC 1997- Assay (C4H11NO3) (dried basis) |
>= 99.0% |
| JPC 1997- Identification A |
Passes Test |
| JPC 1997- Identification B |
Passes Test |
| JPC 1997- pH |
10.3 - 10.7 |
| JPC 1997- Melting Point |
168 - 172°C |
| JP - Clarity and Color of Solution |
Passes Test |
| JPC 1997- Heavy Metals (as Pb) |
<= 8 ppm |
| JPC 1997- Arsenic (As) |
<= 1.6 ppm |
| JPC 1997- Loss on Drying |
<= 0.5% |
| JPC 1997- Residue on Ignition |
<= 0.10% |
| Assay (C4H11NO3) (dried basis) |
>= 99.9% |
| Absorbance of a 1M Solution - 260 nm |
<= 0.06 |
| Absorbance of a 1M Solution - 280 nm |
<= 0.06 |
| Absorbance of a 1M Solution - 400 nm |
<= 0.01 |
| Endotoxin Concentration (EU/g) |
<= 2.5 |
| Iron (Fe) |
<= 1 ppm |
| Lead (Pb) |
<= 1 ppm |
| Ultrapure Bioreagent Specifications No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |
| Manufactured exclusively for Avantor Performance Materials, LLC., by BioSpectra, Inc., Stroudsburg, PA |
| Elemental Impurities (USP 232, EP 5.20) - Information on elemental impurities for this product is available on the associated Product Regulatory Data Sheet and elemental impurity profile report. |