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Finden Sie Pharmazeutisches Zwischenprodukt, Aminosäure, Pharmazeutisches Rohmaterial auf Industry Directory, zuverlässige Hersteller / Lieferant / Fabrik aus China
Zahlungsart: | T/T, D/P |
---|---|
Minimum der Bestellmenge: | 500 |
Lieferzeit: | 1 Tage |
Modell: pharmaceutical material
Product Name: |
Alpha Lipoic Acid (Thioctic Acid - USP GRADE) |
|
Molecular Formula: |
C8H14O2S2 |
|
Molecular Weight: |
206.33 |
|
ITEMS |
SPECIFICATIONS |
RESULTS |
Appearance |
Slightly yellow crystal powder,almost odorless |
Conforms |
Identification |
The retention time of the peak for alpha lipoic acid in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation as obtained in the Assay |
Conforms |
Melting Point |
60C ~ 62C |
62C |
Heavy Metals |
10ppm Max. |
<10ppm |
Lead |
2ppm Max |
<2ppm |
Arsenic |
2ppm Max |
<2ppm |
Loss on Drying |
0.20% Max |
0.18% |
Residue on Ignition |
0.10% Max |
0.06% |
Specific Rotation |
-1.0 to +1.0 |
Conforms |
Limit of Polymer Content |
2.0% Max |
Conforms |
6,8-Epitrithiooctanoic Acid |
0.10% Max |
0.08% |
Single Impurity |
0.10% Max |
0.06% |
Total Impurities |
0.50% Max |
0.23% |
Residual Solvents (by GC) |
|
|
Cyclohexane |
1000ppm Max |
764ppm |
Ethyl Acetate |
250ppm Max |
83ppm |
|
20ppm Max |
11ppm |
Microbiology |
|
|
Total Aerobic Counts |
1000cfu/g Max |
100cfu/g |
Mold and Yeast |
100cfu/g Max |
<10cfu/g |
E.Coli / Salmonella |
Absence/g |
Not detected |
Staphylococcus aureus |
Absence/g |
Not detected |
Particle Size |
100% through 40 mesh |
Conforms |
Loose Bulk Density |
|
0.293g/ml |
Assay |
99% ~ 101% |
99.56% |
Conclusion |
Conformed USP29 |
Conforms |
Produktgruppe : Pharmazeutisches Zwischenprodukt