Specification Test Results

• Assay (NF- Anhydrous basis, EP- Anhydrous substance):
  97.0- 102.0%
• Appearance of solution (2.2.1 & 2.2.2):
  PASS
• Bacterial Endotoxins:
  ≤ 2.5 EU/g
• Chloride<221> :
  ≤ 0.0125%
• Chlorides (2.4.4):
  ≤ 125 ppm
• Color and Clarity of Solution:
  PASS
• Escherichia coli <62>:
  ABSENT
• Heavy Metals <231>:
  ≤ 5 ppm
• Identification A (USP, EP):
  PASS
• Identification B (USP, EP):
  PASS
• Identification C (USP, EP):
  PASS
• Microbial Contamination (2.6.12): TAMC:
  ≤ 1000 CFU/g
• Microbial Contamination (2.6.12): TYMC:
  ≤ 100 CFU/g
• Microbial Contamination (2.6.13): Escherichia coli:
  ABSENT
• Microbial Contamination (2.6.13): Salmonella:
  ABSENT
• Nitrogen Determination <461>:
  ≤ 0.005%
• pH <791>, (2.2.3):
  4.5 - 6.5
• Related Substances (NF):
  ≤ 0.5%
• Related Substances (NF- Disregard Limit):
  ≤ 0.1%
• Related Substances (EP- Impurities A,B):
  ≤ 0.5%
• Related Substances (EP- Total):
  ≤ 1.0%
• Related Substances (EP- Unspecified Impurities):
  ≤ 0.2%
• Residue after Ignition <281>:
  ≤ 0.1%
• Salmonella <62>:
  ABSENT
• Soluble Starch Test (NF, EP):
  PASS
• Specific Rotation <781S>, (2.2.7):
  +197 - +201 Degrees
• Sulfated Ash (2.4.14):
  ≤ 0.1%
• Sulfate <221>:
  ≤ 0.0200%
• Sulfates (2.4.13):
  ≤ 200 ppm
• Total Aerobic Microbial Count <61>:
  ≤ 100 CFU/g
• Total Combined Molds and Yeasts Count <61>:
  ≤ 100 CFU/g
• Water Determination <921>, (2.5.12):
  9.0 – 11.0%