Specification Test Results
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GMP Manufactured Product |
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Meets B.P. Chemical Specifications |
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Meets E.P. Chemical Specifications |
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Meets J.P. Chemical Specifications |
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Meets N.F. Requirements |
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CAUTION: For Manufacturing, processing or repackaging |
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Bulk Pharmaceutical Chemical |
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NF - Assay (HPLC) |
97.0 - 102.0 % |
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NF - Chloride (Cl) |
≤0.0125 % |
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NF - Color and Clarity of Solution: Absorbance @ 720 nm |
≤0.050 |
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NF - Color and Clarity of Solution, Absorption difference |
≤0.100 |
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NF - Identification A |
Passes Test |
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NF - Identification B |
Passes Test |
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NF - Identification C |
Passes Test |
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NF - Microbial Limits: TAMC (cfu/g) |
≤100 cfu/g |
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NF - Microbial Limits: TYMC (cfu/g) |
≤100 cfu/g |
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NF - Microbial Limits: E. coli |
None Detected |
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NF - Microbial Limits: Salmonella |
None Detected |
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NF - Nitrogen content |
≤0.005 % |
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NF - pH of 10% solution |
4.5 - 6.5 |
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NF - Related Substances - total peaks eluting before trehalose |
≤0.5 % |
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NF - Related Substances - total peaks eluting after trehalose |
≤0.5 % |
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NF - Residue on Ignition |
≤0.10 % |
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NF - Soluble starch |
Passes Test |
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NF - Specific Optical Rotation, anhydrous [Å]²º^D (+) |
197 - 201 Degree |
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NF - Sulfate (SO₄) |
≤0.0200 % |
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NF - Water (by Karl Fischer titration) |
9.0 - 11.0 % |
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EP/BP - Appearance of Solution |
Passes Test |
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EP/BP - Assay (LC) |
97.0 - 102.0 % |
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EP/BP - Chloride (Cl) |
≤125 ppm |
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EP/BP - Identification A |
Passes Test |
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EP/BP - Identification B |
Passes Test |
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EP/BP - Identification C |
Passes Test |
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EP/BP - Microbial Limits: TAMC (cfu/g) |
≤100 cfu/g |
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EP/BP - Microbial Limits: TYMC (cfu/g) |
≤100 cfu/g |
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EP/BP - Microbial Limits: E. coli |
None Detected |
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EP/BP - Microbial Limits: Salmonella |
None Detected |
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EP/BP - pH of 10% solution |
4.5 - 6.5 |
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EP/BP - Related Substances - Impurity A |
≤0.5 % |
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EP/BP - Related Substances - Impurity B |
≤0.5 % |
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EP/BP - Related Substances - Unspecified Impurities, each |
≤0.05 % |
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EP/BP - Related Substances - Total Impurities |
≤1.0 % |
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EP/BP - Soluble starch |
Passes Test |
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EP/BP - Specific Optical Rotation, anhydrous [Å]²º^D (+) |
197 - 201 Degree |
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EP/BP - Sulfate (SO₄) |
≤200 ppm |
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EP/BP - Sulfated ash |
≤0.1 % |
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EP/BP - Water (by Karl Fischer |
9.0 - 11.0 % |
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JP - Assay (LC) |
98.0 - 101.0 % |
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JP - Chloride (Cl) |
≤0.018 % |
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JP - Dextrin, soluble starch and sulfite |
Passes Test |
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JP - Heavy Metals (as Pb) |
≤5 ppm |
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JP - Identification 1 |
Passes Test |
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JP - Identification 2 |
Passes Test |
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JP - Identification 3 |
Passes Test |
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JP - Nitrogen |
≤0.005 % |
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JP - pH of 10% solution |
4.5 - 6.5 |
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JP - Related Substances - total peaks eluting before trehalose |
≤0.5 % |
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JP - Related Substances - total peaks eluting after trehalose |
≤0.5 % |
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JP - Residue on Ignition |
≤0.1 % |
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JP - Specific Optical Rotation, anhydrous [Å]²º^D (+) |
197 - 201 Degree |
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JP - Sulfate (SO₄) |
≤0.024 % |
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JP - Water (by Karl Fischer titration) |
9.0 - 11.0 % |
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Appearance (white to off white powder) |
Passes Test |
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Conductivity, uS cm-1 |
≤15 |
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Reducing Sugars |
Passes Test |
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Glucose Area% |
≤0.5 % |
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Microbial Testing - Staphylococcus aureus (USP) |
None Detected |
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Microbial Testing - Pseudomonas aeruginosa (USP) |
None Detected |
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Specific Optical Rotation, dihydrate [Å]²º^D (+) |
177.5 - 180.5 Degree |
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Endotoxin Concentration, EU/g |
≤0.6 |
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Arsenic (As) |
≤0.25 ppm |
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Cadmium (Cd) |
≤0.03 ppm |
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Mercury (Hg) |
≤0.05 ppm |
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Lead (Pb) |
≤0.08 ppm |
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Cobalt (Co) |
≤0.08 ppm |
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Nickel (Ni) |
≤0.33 ppm |
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Vanadium (V) |
≤0.17 ppm |
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Silver (Ag) |
≤0.17 ppm |
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Gold (Au) |
≤1.67 ppm |
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Iridium (Ir) |
≤0.17 ppm |
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Osmium (Os) |
≤0.17 ppm |
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Palladium (Pd) |
≤0.17 ppm |
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Platinum (Pt) |
≤0.17 ppm |
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Rhodium (Rh) |
≤0.17 ppm |
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Ruthenium (Ru) |
≤0.17 ppm |
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Selenium (Se) |
≤1.33 ppm |
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Thallium (Tl) |
≤0.13 ppm |
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Barium (Ba) |
≤11.67 ppm |
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Chromium (Cr) |
≤18.33 ppm |
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Copper (Cu) |
≤5.00 ppm |
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Lithium (Li) |
≤4.17 ppm |
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Molybdenum (Mo) |
≤25.00 ppm |
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Antimony (Sb) |
≤1.50 ppm |
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Tin (Sn) |
≤10.00 ppm |
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Aluminum (Al) |
≤10.00 ppm |
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Residual Methanol |
≤500 ppm |
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Residual Ethanol |
≤833 ppm |
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Residual Isopropanol |
≤833 ppm |
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Residual Solvents: Only the Class 2 solvent Methanol and the Class 3 |
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Solvents Ethanol and Isopropanol are likely to be present. Each is |
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tested and the concentration reported for each batch. |
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Elemental Impurities (USP 232, EP 5.20) - Information on elemental |
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impurities for this product is available on the associated Product |
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Regulatory Data Sheet and elemental impurity profile report. |
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Plant Derived. |
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Suitable for use in the manufacture of parenteral dosage forms. |
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