TEST | SPECIFICATION |
GMP Manufactured Product |
Meets B.P. Chemical Specifications |
Meets E.P. Chemical Specifications |
Preserve in well-closed containers. |
CAUTION: For Manufacturing, processing or repackaging |
Bulk Pharmaceutical Chemical |
NF - Appearance of Solution | Passes Test |
NF - Acidity | Passes Test |
NF - Identification A (IR) | Passes Test |
NF - Identification B (TLC) | Passes Test |
NF - Optical Rotation [Å]²º^D (+) | 78.0 - 81.5 Degree |
NF - Barium (Ba) | Passes Test |
NF - Lead (Pb) | <= 0.5 ppm |
NF - Water (H₂O) | <= 1.0 % |
NF - Residue on Ignition | <= 0.1 % |
EP/BP - Assay (C₆H₁₂O₆)(anhydrous basis) | 97.0 - 102.0 % |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Acidity or Alkalinity | Passes Test |
EP/BP - Identification A (IR) | Passes Test |
EP/BP - Proteins | <= 0.1 % |
EP/BP - Related Substances: Sum of Impurities A and B | <= 1.0 % |
EP/BP - Related Substances:Unspecified impurities, each | <= 0.3 % |
EP/BP - Related Substances:Total impurities | <= 2.0 % |
EP/BP - Specific Optical Rotation [Å]²º^D (+) | 78.0 - 81.5 Degree |
EP/BP - Barium (Ba) | Passes Test |
EP/BP - Lead (Pb) | <= 0.5 ppm |
EP/BP - Water (H₂O) | <= 1.0 % |
EP/BP - Sulfated Ash | <= 0.1 % |
EP/BP - TAMC (cfu/g) | <= 100 cfu/g |
Appearance | Passes Test |
Endotoxin Concentration (EU/g) | <= 2.5 |
Glucose | <= 0.1 % |
Purity (HPLC) | >= 99 % |
Residue on Ignition | <= 0.05 % |
Microbial Testing - Salmonella (USP) | None Detected |
Microbial Testing - E. coli (USP) | None Detected |
Microbial Testing - Staphylococcus aureus (USP) | None Detected |
Microbial Testing - Pseudomonas aeruginosa (USP) | None Detected |
Microbial Testing - Total Yeast and Mold (USP) | <= 100 cfu/g |
Microbial Testing - Total Aerobic Microbial Count (USP) | <= 100 cfu/g |
Solution Clarity (300 mg/mL) | Passes Test |
Solution Color, APHA - For Information Only |
Trace Impurities - Aluminum (Al), For Information Only |
Trace Impurities - Arsenic (As), For Information Only |
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