| TEST |
SPECIFICATION |
| GMP Manufactured Product Meets B.P. Chemical Specifications; Meets E.P. Chemical Specifications; Meets J.P. Chemical Specifications; Meets U.S.P Requirements |
| CAUTION: For Manufacturing, processing or repackaging< Bulk Pharmaceutical Chemical |
| USP - Assay (dried basis) |
97.0 - 102.0% |
| USP - Identification |
Passes Test |
| USP - Related Substances: Sorbitol |
<= 2.0% |
| USP - Related Substances: Sum of isomalt& maltitol |
<= 2.0% |
| USP - Related Substances: Unspecified impurities |
<= 0.10% |
| USP - Related Substances: Total impurities |
<= 2.0% |
| USP - Loss on Drying at 105°C |
<= 0.5% |
| USP - Melting Point |
165 - 170°C |
| USP - Reducing Sugars |
<= 0.1% |
| USP - Nickel (Ni) |
<= 1 ppm |
| USP - Appearance of Solution |
Passes Test |
| USP - Conductivity (uS cm-1) |
<= 20 µS/cm |
| USP - Total Aerobic Microbial Count |
<= 100 cfu/g |
| USP - Total Yeast and Mold Count |
<= 100 cfu/g |
| USP - Escherichia coli |
Passes Test |
| USP - Bacterial Endotoxins, IU/g |
<= 2.5 |
| EP/BP - Assay (as HOCH2(CHOH)4CH2OH) (dried basis) |
97.0 - 102.0% |
| EP/BP - Identification C |
Passes Test |
| EP/BP - Melting Point |
165 - 170°C |
| EP/BP - Appearance of Solution |
Passes Test |
| EP/BP - Conductivity, uS cm-1 |
<= 20 |
| EP/BP - Reducing Sugars |
<= 0.1% |
| EP/BP - Related Substances: Impurity A |
<= 2.0% |
| EP/BP - Related Substances: Sum of Impurities B & C |
<= 2.0% |
| EP/BP - Related Substances: Unspecifiied Impurities, each |
<= 0.10% |
| EP/BP - Related Substances: Total Impurities |
<= 2.0% |
| EP/BP - Nickel (Ni) |
<= 1 ppm |
| EP/BP - Loss on Drying |
<= 0.5% |
| EP/BP - Escherichia coli |
None Detected |
| EP/BP - Salmonella |
None Detected |
| EP/BP - Total Yeast and Mold Count |
<= 100 cfu/g |
| EP/BP - Total Aerobic Microbial Count |
<= 100 cfu/g |
| EP/BP Endotoxin Concentration, <2.5 IU/g |
Passes Test |
| JP - Assay (dried basis) |
97.0 - 102.0% |
| JP - Identification |
Passes Test |
| JP - Related Substances: Sorbitol |
<= 2.0% |
| JP - Related Substances: Sum of isomalt & maltitol |
<= 2.0% |
| JP - Related Substances: Unspecified impurities |
<= 0.10% |
| JP - Related Substances: Total impurities |
<= 2.0% |
| JP - Heavy Metals (as Pb) |
<= 5 ppm |
| JP - Loss on Drying at 105°C |
<= 0.5% |
| JP - Melting Point |
165 - 170°C |
| JP - Glucose |
<= 0.1% |
| JP - Nickel (Ni) |
<= 1 ppm |
| JP - Clarity and Color of Solution |
Passes Test |
| JP - Conductivity (uS cm-1) |
<= 20 µS/cm |
| Suitable for use in the manufacture of parenteral dosage forms. |
| Maximum Endotoxin Concentration: 2.5 IU/g |
| |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |
| 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. |