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| 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 Abarelix Antide | ≥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
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.
*Max1 refers to the Maximum Unknown Impurity limit allowed for each specified product quality indicator.
All products adhere to strict residual solvent limits: Acetic Acid ≤ 0.02%, Ethyl Acetate ≤ 0.5%, and Alcohol ≤ 0.5%.
These compounds serve as key intermediates in the synthesis of various peptide therapeutics including Cetrorelix, Degarelix, Abarelix, Ganirelix, and Antide.
The purified water specification strictly conforms to USP standards, requiring conductivity to be no more than 1.3 µs/cm at 25°C.
Conductivity is monitored online and recorded every 4 hours across primary RO, secondary RO, EDI, and total return points. TOC is tested weekly by the QC department.
Full testing covers physical characters, pH, nitrate, nitrite, ammonia, conductivity, TOC, non-volatile substances, heavy metals, microbial limits, and bacterial endotoxin.
