|
Specifications & Certificate of Analysis
BIOTIN 100% USP
Lot No. BITP020004
Mfg. Date: July, 2002
Exp. Date: July, 2004
| ITEMS |
SPECIFICATIONS |
RESULTS |
| Description |
Practically white crystalline powder |
Conforms |
| Solubility |
Very slightly soluble in water and alcohol;
insoluble in other common organic solvents |
Conforms |
| Identification |
IR Spectrum |
Positive |
| Specific Rotation |
+89° to +93° |
+89.82° |
| Organic Volatile Impurities: |
| Chloroform |
60 ppm Max. |
Not Detected |
| 1,4 Dioxane |
380 ppm Max. |
Not Detected |
| Methylene Dichloride |
600 ppm Max. |
6 ppm |
| Trichloroethylene |
80 ppm Max. |
Not Detected |
| Assay |
97.50 – 100.50 % |
99.29 % |
| Melting Point |
229.0° - 232.0° C |
230.5° C |
| pH |
3.50 – 4.5 |
4.12 |
| Chloride Content |
0.047 % Max. |
< 0.047 % |
| Sulfate Content |
0.032 % Max. |
< 0.032 % |
| Residual Solvents: |
| Methanol |
3,000 ppm Max. |
232 ppm |
| Acetone |
5,000 ppm Max. |
43 ppm |
| Toluene |
890 ppm Max. |
4 ppm |
| Arsenic |
0.0003 % Max. |
< 0.0003 % |
| Copper |
0.0025 % Max. |
< 0.0025 % |
| Mercury |
0.0001 % Max. |
< 0.0001 % |
| Zinc |
0.0025 % Max. |
< 0.0025 % |
| Related Substances: |
| Any Impurity |
0.50 % Max. |
No Impurity |
| One Impurity |
0.25 – 0.50 % |
Conforms |
| Microbiology: |
| Total Plate Count |
100 CFU/g Max. |
< 10 CFU/g |
| Yeast & Mold |
100 CFU/g Max. |
< 10 CFU/g |
| E. Coli |
Absent in 1 g |
Absent |
| Salmonella |
Absent in 1 g |
Absent |
| P. Aeruginosa |
Absent in 1 g |
Absent |
| Staph. Aureus |
Absent in 1 g |
Absent |
|
