Specification Test Results
Meets J.P. Chemical Specifications |
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Meets N.F. Requirements |
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GMP Manufactured Product |
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Meets E.P. Chemical Specifications |
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Store in airtight container. |
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CAUTION: For Manufacturing, processing or repackaging |
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Bulk Pharmaceutical Chemical |
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NF - Clarity and Color of Solution |
Passes Test |
NF - Identification A |
Passes Test |
NF - Identification B |
Passes Test |
NF - Specific Rotation [Å]²º^D (+) |
54.4 - 55.9 Degree |
NF - Microbial Limits - Total Aerobic Microbial Counts, cfu/g |
≤100 |
NF - Microbial Limits - Total Combined Molds and Yeasts Count (per g) |
≤50 |
NF - Microbial Limits - Escherichia Coli and Salmonella |
Passes Test |
NF - Acidity or Alkalinity |
Passes Test |
NF - Loss on Drying at 80°C |
≤0.5 % |
NF - Water (H₂O) |
4.5 - 5.5 % |
NF - Residue on Ignition |
≤0.1 % |
NF - Protein and Light-Absorbing Impurities |
Passes Test |
EP - Identification A |
Passes Test |
EP - Identification B |
Passes Test |
EP - Identification C |
Passes Test |
EP - Identification D |
Passes Test |
EP - Specific Rotation [Å]²º^D (+) |
54.4 - 55.9 Degree |
EP - Sulfated Ash |
≤0.1 % |
EP - Microbial Limits - Total Aerobic Microbial Count, cfu/g |
≤100 |
EP- Microbial Limits - Total Combined Molds and Yeasts Count (per g) |
≤50 |
EP - Microbial Limits - Escherichia coli (absent) |
Passes Test |
EP - Acidity or Alkalinity |
Passes Test |
EP - Water (H₂O) |
4.5 - 5.5 % |
EP - Protein and Light-Absorbing Impurities |
Passes Test |
EP - Appearance of Solution |
Passes Test |
JP - Clarity and Color of Solution |
Passes Test |
JP - Identification A |
Passes Test |
JP - Specific Rotation [Å]²º^D (+) |
54.4 - 55.9 Degree |
JP - Microbial Limits - Total Aerobic Microbial Count, cfu/g |
≤100 |
JP - Microbial Limits - Total Combined Molds and Yeasts Count (per g) |
≤50 |
JP - Microbial Limits - Escherichia Coli and Salmonella |
Passes Test |
JP - Acidity or Alkalinity |
Passes Test |
JP - Water (H₂O) |
4.5 - 5.5 % |
JP - Loss on Drying at 80°C |
≤0.5 % |
JP - Residue on Ignition |
≤0.10 % |
JP - Heavy Metals (as Pb) |
≤5 ppm |
JP - Protein and Light-Absorbing Impurities |
Passes Test |
Endotoxin Concentration (EU/g), For Information Only |
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No Class 1,2,3 or other solvents are used or produced in the |
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manufacturing or purification of the product. |
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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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Internationally Harmonized |
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