Stearic Acid, Powder, NF - GenAR®, Macron™
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Stearic Acid, Powder, NF - GenAR®, Macron™
Formula: C18H36O2
Formula Weight: 284.48
Vegetable Grade, 50
TEST |
SPECIFICATION |
GMP Manufactured Product |
Meets B.P. Chemical Specifications |
Meets E.P. Chemical Specifications |
Meets J.P. Chemical Specifications |
Meets N.F. Requirements |
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 - Nickel (Ni) |
<= 1 ppm |
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. |
CAS Number |
57-11-4 |
HTS Number |
3823110000 |
Density |
1L = 0.94kg |
Flash Point |
196.00°C |
Management of Change |
R |