Specification Test Results
Food GMP Manufactured Product |
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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 F.C.C. Requirements |
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Meets J.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 Food Chemical |
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Bulk Pharmaceutical Chemical |
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FCC - Assay (C₆H₉N₃O₂·HCl) (dried basis) |
98.5 - 101.5 % |
FCC - Identification |
Passes Test |
FCC - Lead (Pb) |
≤ 5 mg/kg |
FCC - Loss on Drying at 105°C |
≤ 0.3 % |
FCC - Residue after Ignition |
≤ 0.10 % |
FCC - Specific Rotation [Å]²º^D (+) |
8.5 - 10.5 Degree |
EP/BP - Assay (C₆H₉N₃O₂·HCl) (dried basis) |
98.5 - 101.0 % |
EP/BP - Identification A |
Passes Test |
EP/BP - Identification B |
Passes Test |
EP/BP - Identification C |
Passes Test |
EP/BP - Identification F |
Passes Test |
EP/BP - Appearance of Solution |
Passes Test |
EP/BP - pH |
3.0 - 5.0 |
EP/BP - Specific Rotation [Å]²º^D (+) |
9.2 - 10.6 Degree |
EP/BP-Ninhydrin-Positive Substances-Each |
≤ 0.2 % |
EP/BP-Ninhydrin-Positive Substances-Total Impurities |
≤ 0.5 % |
EP/BP - Sulfate (SO₄) |
≤ 300 ppm |
EP/BP - Ammonium (NH₄) |
≤ 0.02 % |
EP/BP - Iron (Fe) |
≤ 10 ppm |
EP/BP - Loss on Drying at 150°C |
7.0 - 10.0 % |
EP/BP - Ash (sulfated) |
≤ 0.1 % |
JP - Identification |
Passes Test |
JP - Optical Rotation (+) |
9.2 - 10.6 |
JP - pH |
3.5 - 4.5 |
JP - Clarity and Color of Solution |
Passes Test |
JP - Sulfate (SO₄) |
≤ 0.028 % |
JP - Ammonium (NH₄) |
≤ 0.02 % |
JP - Heavy Metals (as Pb) |
≤ 10 ppm |
JP - Iron (Fe) |
≤ 10 ppm |
JP - Related Substances |
Passes Test |
JP - Water |
7.2 - 10.0 % |
JP - Residue on Ignition |
≤ 0.10 % |
JP - Assay (anhydrous basis) |
99.0 - 101.0 % |
Microbial Testing – Total Aerobic Microbial Count (USP) |
≤ 10 cfu/g |
Microbial Testing – Total Yeast and Mold Count (USP) |
≤ 10 cfu/g |
Endotoxin Concentration (EU/g) |
≤ 10 |
Trace Impurities - Cadmium (Cd) |
≤ 200 ppb |
Trace Impurities - Lead (Pb) |
≤ 500 ppb |
Trace Impurities - Arsenic (As) |
≤ 1500 ppb |
Trace Impurities - Mercury (Hg) |
≤ 300 ppb |
Trace Impurities - Cobalt (Co) |
≤ 500 ppb |
Trace Impurities - Vanadium (V) |
≤ 1000 ppb |
Trace Impurities - Nickel (Ni) |
≤ 2000 ppb |
Trace Impurities - Thallium (Tl) |
≤ 800 ppb |
Trace Impurities - Gold (Au) |
≤ 10000 ppb |
Trace Impurities - Palladium (Pd) |
≤ 1000 ppb |
Trace Impurities - Iridium (Ir) |
≤ 1000 ppb |
Trace Impurities - Osmium (Os) |
≤ 1000 ppb |
Trace Impurities - Rhodium (Rh) |
≤ 1000 ppb |
Trace Impurities - Ruthenium (Ru) |
≤ 1000 ppb |
Trace Impurities - Selenium (Se) |
≤ 8000 ppb |
Trace Impurities - Silver (Ag) |
≤ 1000 ppb |
Trace Impurities - Platinum (Pt) |
≤ 1000 ppb |
Trace Impurities - Lithium (Li) |
≤ 25000 ppb |
Trace Impurities - Antimony (Sb) |
≤ 9000 ppb |
Trace Impurities - Barium (Ba) |
≤ 70000 ppb |
Trace Impurities - Molybdenum (Mo) |
≤ 150000 ppb |
Trace Impurities - Copper (Cu) |
≤ 30000 ppb |
Trace Impurities - Tin (Sn) |
≤ 60000 ppb |
Trace Impurities - Chromium (Cr) |
≤ 110000 ppb |
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 |
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elemental impurities for this product is available on the associated |
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Product Regulatory Data Sheet and elemental impurity profile report. |
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