Specification Test Results

• Meets N.F. Requirements:
• Meets J.P. Chemical Specifications:
• Meets E.P. Chemical Specifications:
• GMP Manufactured Product:
• Meets B.P. Chemical Specifications:
• Preserve in well-closed containers.:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Pharmaceutical Chemical:
• NF - Identification A:
  Passes Test
• NF - Identification B (Acid Value):
  194 - 212
• NF - Identification C:
  Passes Test
• NF - Residue on Ignition:
  ≤ 0.1 %
• NF - Acidity:
  Passes Test
• NF - Color of Solution:
  Passes Test
• NF - Iodine Value:
  ≤ 4.0
• NF - Freezing Point:
  53 - 59 °C
• NF - Assay (C₁₈H₃₆O₂) (stearic acid):
  40.0 - 60.0 %
• NF - Assay (Total of Stearic & Palmitic):
  ≥ 90.0 %
• EP/BP - Identification A:
  Passes Test
• EP/BP - Identification B:
  Passes Test
• EP/BP - Identification C:
  Passes Test
• EP/BP - Appearance:
  Passes Test
• EP/BP - Acidity:
  Passes Test
• EP/BP - Iodine Value:
  ≤ 4.0
• EP/BP - Freezing Point:
  53 - 59 °C
• EP/BP - Stearic Acid:
  40.0 - 60.0 %
• EP/BP - Stearic and Palmitic Acids:
  ≥ 90.0 %
• JP - Stearic and Palmitic Acids:
  ≥ 90.0 %
• JP - Stearic Acid:
  40.0 - 60.0 %
• JP - Acid Value:
  194 - 212
• JP - Iodine Value:
  ≤ 4.0
• JP - Acidity:
  Passes Test
• JP - Heavy Metals (as Pb):
  ≤ 20 ppm
• JP - Congealing Point:
  53 - 59 °C
• JP - Residue on Ignition:
  ≤ 0.10 %
• Thru U.S. No. 30 Sieve:
  99.5 - 100.0 %
• Thru U.S. No. 60 Sieve, For Information Only:
• Thru U.S. No. 100 Sieve:
  95.0 - 100.0 %
• Thru U.S. No. 200 Sieve, For Information Only:
• Appearance (fine, white or yellowish-white powder):
• No Class 1,2,3 or other solvents are used or produced in the:
• manufacturing or purification of the product.:
• 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.: