
Working hours:
Monday to Friday - 9.30 to 6.00 Saturday - 9.30 to 4.00
ITEMS |
SPECIFICATIONS (TEST METHOD) |
RESULT |
Appearance |
White powder |
Pass |
Taste |
Characteristic |
Pass |
Odor |
Characteristic |
Pass |
Assay (On dry basis) |
98.0 %~ 102.0%(HPLC) |
99.6% |
Specific Rotation |
+39.0~+43.0(USP781) |
+41.3 |
Chloride |
NMT 0.1% |
0.02 |
PH |
5.0 ~ 7.0(USP791) |
0.58 |
Loss on Drying |
0.5%(USP731) |
0.12 |
Residue on Ignition |
NMT 0.1%(USP281) |
<0.1% |
Heavy Metals |
NMT 10PPM(USP231) |
Negative |
Arsenic(AS2O3) |
NMT 1PPM(MethodUSP211) |
Negative |
Melt point |
196 .0~ 205.0(USP2022) |
Pass |
Total Bacteria Count |
1000CFU/g(USP2021) |
<100 |
Yeast & Mold |
100CFU/g(USP2021) |
<10 |
Salmonella |
Negative |
Pass |
E.Coli |
Negative |
Pass |
Staphylococcus Aureus |
Negative |
Pass |
Particle size |
98% through80mesh |
pass |
Storage: Preserve in tight, light-resistant container |
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CONCLUSION: CONFORM TO USP-NF2024 REQUIREMENTS |
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