Specification Test Results
Meets N.F. Requirements |
|
GMP Manufactured Product |
|
Meets B.P. Chemical Specifications |
|
Meets J.P. Chemical Specifications |
|
Meets E.P. Chemical Specifications |
|
CAUTION: For Manufacturing, processing or repackaging |
|
Bulk Pharmaceutical Chemical |
|
NF - Assay (HPLC) |
97.0 - 102.0 % |
NF - Chloride (Cl) |
≤0.0125 % |
NF - Color and Clarity of Solution: Absorbance @ 720 nm |
≤0.050 |
NF - Color and Clarity of Solution, Absorption difference |
≤0.100 |
NF - Identification A |
Passes Test |
NF - Identification B |
Passes Test |
NF - Identification C |
Passes Test |
NF - Microbial Limits: TAMC (cfu/g) |
≤100 cfu/g |
NF - Microbial Limits: TYMC (cfu/g) |
≤100 cfu/g |
NF - Microbial Limits: E. coli |
None Detected |
NF - Microbial Limits: Salmonella |
None Detected |
NF - Nitrogen content |
≤0.005 % |
NF - pH of 10% solution |
4.5 - 6.5 |
NF - Related Substances - total peaks eluting before trehalose |
≤0.5 % |
NF - Related Substances - total peaks eluting after trehalose |
≤0.5 % |
NF - Residue on Ignition |
≤0.10 % |
NF - Soluble starch |
Passes Test |
NF - Specific Optical Rotation, anhydrous [Å]²º^D (+) |
197 - 201 Degree |
NF - Sulfate (SO₄) |
≤0.0200 % |
NF - Water (by Karl Fischer titration) |
9.0 - 11.0 % |
EP/BP - Appearance of Solution |
Passes Test |
EP/BP - Assay (LC) |
97.0 - 102.0 % |
EP/BP - Chloride (Cl) |
≤125 ppm |
EP/BP - Identification A |
Passes Test |
EP/BP - Identification B |
Passes Test |
EP/BP - Identification C |
Passes Test |
EP/BP - Microbial Limits: TAMC (cfu/g) |
≤100 cfu/g |
EP/BP - Microbial Limits: TYMC (cfu/g) |
≤100 cfu/g |
EP/BP - Microbial Limits: E. coli |
None Detected |
EP/BP - Microbial Limits: Salmonella |
None Detected |
EP/BP - pH of 10% solution |
4.5 - 6.5 |
EP/BP - Related Substances - Impurity A |
≤0.5 % |
EP/BP - Related Substances - Impurity B |
≤0.5 % |
EP/BP - Related Substances - Unspecified Impurities, each |
≤0.2 % |
EP/BP - Related Substances - Total Impurities |
≤1.0 % |
EP/BP - Soluble starch |
Passes Test |
EP/BP - Specific Optical Rotation, anhydrous [Å]²º^D (+) |
197 - 201 Degree |
EP/BP - Sulfate (SO₄) |
≤200 ppm |
EP/BP - Sulfated ash |
≤0.1 % |
EP/BP - Water (by Karl Fischer |
9.0 - 11.0 % |
JP - Assay (LC) |
98.0 - 101.0 % |
JP - Chloride (Cl) |
≤0.018 % |
JP - Dextrin, soluble starch and sulfite |
Passes Test |
JP - Heavy Metals (as Pb) |
≤5 ppm |
JP - Identification 1 |
Passes Test |
JP - Identification 2 |
Passes Test |
JP - Identification 3 |
Passes Test |
JP - Nitrogen |
≤0.005 % |
JP - pH of 10% solution |
4.5 - 6.5 |
JP - Related Substances - total peaks eluting before trehalose |
≤0.5 % |
JP - Related Substances - total peaks eluting after trehalose |
≤0.5 % |
JP - Residue on Ignition |
≤0.1 % |
JP - Specific Optical Rotation, anhydrous [Å]²º^D (+) |
197 - 201 Degree |
JP - Sulfate (SO₄) |
≤0.024 % |
JP - Water (by Karl Fischer titration) |
9.0 - 11.0 % |
Appearance (white to off white powder) |
Passes Test |
Conductivity, uS cm-1 |
≤15 |
Reducing Sugars |
Passes Test |
Glucose Area% |
≤0.5 % |
Microbial Testing - Staphylococcus aureus (USP) |
None Detected |
Microbial Testing - Pseudomonas aeruginosa (USP) |
None Detected |
Specific Optical Rotation, dihydrate [Å]²º^D (+) |
177.5 - 180.5 Degree |
Endotoxin Concentration, EU/g |
≤0.6 |
Trace Impurities - Aluminum (Al), For Information Only |
|
Trace Impurities - Arsenic (As), For Information Only |
|
Trace Impurities - Cadmium (Cd), For Information Only |
|
Trace Impurities - Chromium (Cr), For Information Only |
|
Trace Impurities - Copper (Cu), For Information Only |
|
Trace Impurities - Iridium (Ir), For Information Only |
|
Trace Impurities - Iron (Fe), For Information Only |
|
Trace Impurities - Lead (Pb), For Information Only |
|
Trace Impurities - Manganese (Mn), For Information Only |
|
Trace Impurities - Mercury (Hg), For Information Only |
|
Trace Impurities - Molybdenum (Mo), For Information Only |
|
Trace Impurities - Nickel (Ni), For Information Only |
|
Trace Impurities - Osmium (Os), For Information Only |
|
Trace Impurities - Palladium (Pd), For Information Only |
|
Trace Impurities - Platinum (Pt), For Information Only |
|
Trace Impurities - Rhodium (Rh), For Information Only |
|
Trace Impurities - Ruthenium (Ru), For Information Only |
|
Trace Impurities - Vanadium (V), For Information Only |
|
Trace Impurities - Zinc (Zn), For Information Only |
|
Residual Methanol |
≤3000 ppm |
Residual Ethanol |
≤5000 ppm |
Residual Isopropanol |
≤5000 ppm |
Cyanide (CN) |
≤100 ppb |
Residual Solvents: Only the Class 2 solvent Methanol and the Class 3 |
|
Solvents Ethanol and Isopropanol are likely to be present. Each is |
|
tested and the concentration reported for each batch. |
|
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. |
|
Plant Derived. |
|
Suitable for use in the manufacture of parenteral dosage forms. |
|