Specification Test Results
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GMP Manufactured Product |
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Meets BP. Chemical Specifications |
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Meets EP Chemical Specifications |
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Meets JP Chemical Specifications |
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Meets NF 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 - Colour and Clarity of Solution: Absorbance at 720 nm |
≤0.050 |
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NF - Colour 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 α²ºD (+) |
197 - 201° |
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NF - Sulphate (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 |
≤0.2% |
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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 α²ºD (+) |
197 - 201° |
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EP/BP - Sulphate (SO₄) |
≤200 ppm |
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EP/BP - Sulphated Ash |
≤0.1% |
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EP/BP - Water (by Karl Fischer Titration) |
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 Sulphite |
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 α²ºD (+) |
197 - 201° |
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JP - Sulphate (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 α²ºD (+) |
177.5 - 180.5° |
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Endotoxin Concentration, EU/g |
≤0.6 |
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Trace Impurities - Aluminum (Al), For Information Only |
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Trace Impurities - Arsenic (As), For Information Only |
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Trace Impurities - Cadmium (Cd), For Information Only |
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Trace Impurities - Chromium (Cr), For Information Only |
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Trace Impurities - Copper (Cu), For Information Only |
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Trace Impurities - Iridium (Ir), For Information Only |
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Trace Impurities - Iron (Fe), For Information Only |
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Trace Impurities - Lead (Pb), For Information Only |
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Trace Impurities - Manganese (Mn), For Information Only |
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Trace Impurities - Mercury (Hg), For Information Only |
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Trace Impurities - Molybdenum (Mo), For Information Only |
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Trace Impurities - Nickel (Ni), For Information Only |
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Trace Impurities - Osmium (Os), For Information Only |
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Trace Impurities - Palladium (Pd), For Information Only |
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Trace Impurities - Platinum (Pt), For Information Only |
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Trace Impurities - Rhodium (Rh), For Information Only |
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Trace Impurities - Ruthenium (Ru), For Information Only |
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Trace Impurities - Vanadium (V), For Information Only |
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Trace Impurities - Zinc (Zn), For Information Only |
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Residual Methanol |
≤3000 ppm |
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Residual Ethanol |
≤5000 ppm |
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Residual Isopropanol |
≤5000 ppm |
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Cyanide (CN) |
≤100 ppb |
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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 |
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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 |
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Plant Derived. |
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Suitable for Use in the Manufacture of Parenteral Dosage Frms |
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