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Finden Sie Pharmazeutisches Zwischenprodukt, Aminosäure, Pharmazeutisches Rohmaterial auf Industry Directory, zuverlässige Hersteller / Lieferant / Fabrik aus China
Zahlungsart: | L/C, T/T, D/P |
---|---|
Minimum der Bestellmenge: | 2000 |
Lieferzeit: | 1 Tage |
Product: N acetyl L cysteine | ||||
Item |
Specification (USP37) |
Result |
Methods |
|
Appearance |
White powder |
Conforms |
Visual |
|
Identification |
Infrared Absorption |
Conforms |
IR |
|
Assay |
98.5 to 101.5% |
99.50% |
USP- ASSAY |
|
(Calculated on the dried basis) | ||||
Specific rotation [α] 25D |
-9.8°to -11.2° |
-10.4° |
USP-781S |
|
Loss on Drying |
Not more than 0.3 % |
0.22% |
USP-731 |
|
Residue on ignition |
Not more than 0.4% |
0.18% |
USP-281 |
|
Chloride (Cl) |
Not more than 0.04% |
<0.04% |
USP-221 |
|
Sulfate (SO4) |
Not more than 0.04% |
<0.04% |
USP-221 |
|
Iron (Fe) |
Not more than 30ppm |
<30ppm |
USP-241 |
|
Heavy metals (Pb) |
Not more than 15ppm |
<15ppm |
USP-231 |
|
Lead |
Not more than 3ppm |
<3ppm |
AFS |
|
Chromatographic purity |
Chromatographically not detectable |
Conforms |
USP |
|
Residual Solvents |
Meets the requirements |
Meet the requirements |
USP |
|
Total plate count |
Less than 1000 cfu/g |
Conforms |
CP |
|
Yeast & molds |
Less than 100 cfu/g |
Conforms |
CP |
|
Coliforms: |
Less than 10 cfu/g |
Conforms |
CP |
|
E Coli |
Negative |
Negative |
CP |
|
Salmonella |
Negative |
Negative |
CP |
|
Pseudomonas |
Negative |
Negative |
CP |
|
S.Aureus |
Negative |
Negative |
CP |
|
Conclusion :Agree with the specification of USP37. |
Produktgruppe : Pharmazeutisches Zwischenprodukt