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1.

Asam Sitrat

Test JP XV PhEur 6.0 USP 32


Identification + + +
Characters - + -
Appereamce Of Solutions + + +
Water
(Hydrous form) 7.5 – 9.0 % 7.5 – 9.0 % 7.5 – 9.0 %
(Anhydrous form) ≤ 1.0 % ≤ 1.0 % ≤ 1.0 %
Sterility - - +
Bacterial Endotoxins - + +
Residue on ignitions ≤ 0.1 % - ≤ 0.1 %
Sulfated ash - ≤ 0.1 % -
Aluminum - ≤ 0.2 ppm ≤ 0.2 μg/g
Calcium + - -
Oxalic Acid + ≤ 360 ppm ≤ 0.036 %
Sulfate + ≤ 150 ppm ≤ 0.015 %
Heavy metals ≤ 10 ppm ≤ 10 ppm ≤ 0.001 %
Readily Carbonizable + + +
Substance
Assay (Anhydrous Basis)
99.5 – 100.5 %
99.5 – 101.0 %

2. Magnesium Stearat

Test JP XV PhEur 6.5 USP 32


Identification + + +
Characters - + -
Microbial limits + + +
Aerobic microbes ≤ 1000 cfu/g ≤ 10³ cfu/g ≤ 1000 cfu/g
Fungi and yeasts ≤ 500 cfu/g ≤ 10² cfu/g ≤ 500 cfu/g
Acidity or Alkalinity + + +
Acid value of fatty acid - 195 – 210 -
Frezing point - ≥ 53 ⁰ C -
Nickle - ≤ 5 ppm -
Cadmium - ≤ 3 ppm -
Specific surface area - - +
Loss on drying ≤ 6.0% ≤ 6.0% ≤ 6.0%
Chloride ≤ 0.1% ≤ 0.1% ≤ 0.1%
Sulfate ≤ 1.0% ≤ 1.0% ≤ 1.0%
Lead - ≤ 10 ppm ≤ 0.001%
Heavy metals ≤ 20 ppm - -
Relative stearic / palmitic + + +
content
Assay (dried, as mg) 4.0 – 5.0 % 4.0 – 5.0 % 4.0 – 5.0 %

3. Avicel

Test JP XV PhEur 6.0 USP 32


Identification + + +
Characters + + -
pH 5.0 – 7.5 5.0 – 7.5 5.0 – 7.5
Bulk density + - +
Loss on drying ≤ 7.0% ≤ 7.0% ≤ 7.0%
Residue on ignitions ≤ 0.1% - ≤ 0.1%
Conductivity + + +
Sulfated ash - ≤ 0.1% -
Ether-soluble substance ≤ 0.05% ≤ 0.05% ≤ 0.05%
Water-soluble substance + ≤ 0.25% ≤ 0.25%
Heavy metals ≤ 10 ppm ≤ 10 ppm ≤ 0.001 %
Microbial limits + + +
Aerobic microbes ≤ 10³ cfu/g ≤ 10³ cfu/g ≤ 10³ cfu/g
Molds and yeasts ≤ 10² cfu/g ≤ 10² cfu/g ≤ 10² cfu/g
Solubility - + -
Particle distribution - - +