NO |
Products |
CAS No. |
Application |
Key Quality Indicator |
||||
Purity |
Isomer |
Specific impurity |
*Max1 |
Moisture |
||||
1 |
Fmoc-3-(2-naphthyl)-D-Ala-OH |
138774-94-4 |
Most products |
≥99.0% |
≤0.2% |
≤0.3% |
≤0.3% |
≤1.0% |
2 |
Ac-3-(2-naphthyl)-D-Ala-OH |
37440-01-0 |
Most products |
≥99.0% |
≤0.2% |
≤0.3% |
≤0.3% |
≤1.0% |
3 |
Fmoc-3-(3-pyridinyl)-D-Ala-OH |
142994-45-4 |
Most products |
≥99.0% |
≤0.2% |
≤0.3% |
≤0.3% |
≤1.0% |
4 |
Fmoc-4-chloro-D-Phe-OH |
142994-19-2 |
Most products |
≥99.0% |
≤0.2% |
≤0.3% |
≤0.3% |
≤1.0% |
5 |
Fmoc-D-Cit-OH |
200344-33-8 |
Cetrorelix |
≥99.5% |
≤0.1% |
≤0.1% |
≤0.2% |
≤1.0% |
6 |
Fmoc-D-Ala-OH.H2O |
79990-15-1 |
Most products |
≥99.5% |
≤0.1% |
≤0.1% |
≤0.2% |
≤6.5% |
7 |
Fmoc-D-Aph(tBuCbm)-OH |
1433975-21-3 |
Degarelix |
≥99.0% |
≤0.2% |
≤0.3% |
≤0.3% |
≤1.0% |
8 |
Fmoc-D-Aph(Cbm)-OH |
324017-22-3 |
Degarelix |
≥99.0% |
≤0.2% |
≤0.3% |
≤0.3% |
≤1.0% |
9 |
Fmoc-L-Aph(L-Hor)-OH |
1253282-31-3 |
Degarelix |
≥99.0% |
≤0.2% |
≤0.3% |
≤0.3% |
≤1.0% |
10 |
Fmoc-L-Lys(iPr,Boc)-OH |
201003-48-7 |
Degarelix |
≥99.0% |
≤0.2% |
≤0.3% |
≤0.3% |
≤1.0% |
11 |
Fmoc-N-Me-Tyr(tBu)-OH |
133373-24-7 |
Abarelix |
≥99.0% |
≤0.2% |
≤0.3% |
≤0.3% |
≤1.0% |
12 |
Fmoc-D-Asn(Trt)-OH |
180570-71-2 |
Abarelix |
≥99.0% |
≤0.2% |
≤0.3% |
≤0.3% |
≤1.0% |
13 |
Fmoc-HomoArg(Et)2-OH.HCl |
1864003-26-8 |
Ganirelix |
≥95.0% |
≤0.5% |
≤1.0% |
≤2.0% |
≤2.0% |
14 |
Fmoc-D-HomoArg(Et)2-OH.HCl |
2098497-24-4 |
Ganirelix |
≥95.0% |
≤0.5% |
≤1.0% |
≤2.0% |
≤2.0% |
15 |
Fmoc-Lys(nicotinoyl)-OH |
252049-11-9 |
Antide |
≥98.0% |
≤0.2% |
≤0.3% |
≤0.5% |
≤1.0% |
16 |
Fmoc-D-Lys(nicotinoyl)-OH |
252049-12-0 |
Antide |
≥98.0% |
≤0.2% |
≤0.3% |
≤0.5% |
≤1.0% |
* Max1 = Max Unknown Impurity
Other Indicator:
- Acetic Acid: ≤0.02% (All Products)
- Ethyl Acetate: ≤0.5% (All Products)
- Alcohol: ≤0.5% (All Products)
TOC and conductivity of main supply and return points are monitored periodically. TOC is monitored by QC on every week. Conductivity is monitored online and recorded by purified water station operator once every four hours. The conductivity is monitored at the primary RO, secondary RO, EDI and total return point of distribution system. The specification of purified water is in place and conforms to pre-defined specification which no more than 1.3 µs/cm at 25°C (USP). For main supply and return points, full test. is performed every week, for other using point in the circulating loop, full test is performed once every month. The full test includes characters, pH, nitrate, nitrite, ammonia, conductivity, TOC, non-volatile substances, heavy metals, microbial limits and bacterial endotoxin.