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法規制遵守
FCC
品質水準
形状
solid
mp
261-262 °C (decomposition)
溶解性
insoluble 0.19 g/L
密度
1.677 g/cm3 at 20 °C
かさ密度
300 kg/m3
アプリケーション
pharma/biopharma processes
保管温度
2-30°C
InChI
1S/C6H12N2O4S2/c7-3(5(9)10)1-13-14-2-4(8)6(11)12/h3-4H,1-2,7-8H2,(H,9,10)(H,11,12)/t3-,4-/m0/s1
InChI Key
LEVWYRKDKASIDU-IMJSIDKUSA-N
詳細
Our SAFC® portfolio of high-quality raw materials for use in biopharmaceutical processing withstands strict quality control procedures plus the documentation and expertise to help our customers meet requirements as defined by the M-Clarity Program.
M-Clarity Program
Our comprehensive portfolio of upstream process chemicals not only provides biopharmaceutical manufacturers with high-quality raw materials for production of classical and novel therapies, but also helps them get to market faster and simplify regulatory challenges. Trust us to deliver supply chain transparency and reliable sourcing around the globe, streamlining your product qualification with best-in-class regulatory support and service.
M-Clarity Program
Our comprehensive portfolio of upstream process chemicals not only provides biopharmaceutical manufacturers with high-quality raw materials for production of classical and novel therapies, but also helps them get to market faster and simplify regulatory challenges. Trust us to deliver supply chain transparency and reliable sourcing around the globe, streamlining your product qualification with best-in-class regulatory support and service.
We offer a range of high quality critical raw materials plus the documentation and expertise to help our customers meet stringent regulatory requirements. Our SAFC® portfolio of high-quality products withstands strict quality control procedures.
アナリシスノート
Assay (ex N, calc. on dried substance): 98.5 - 101.5 %
Identity (IR-spectrum): passes test
Appearance: white to almost white, fine-crystalline powder
Appearance of solution (100 g/l, hydrochloric acid 2 mol/l): clear and colorless
Spec. rotation (α 20/D, 20 g/l, hydrochloric acid 1 mol/l, previously dried substance): -215 to -225
Heavy metals (as Pb): ≤ 10 ppm
Pb (Lead): ≤ 5 ppm
Ninhydrin - positive substances (LC) (largest single impurity): ≤ 0.2 %
Ninhydrin - positive substances (LC) (Sum of all impurities): ≤ 0.5 %
Sulfated ash (800 °C): ≤ 0.1 %
Loss on drying (105 °C; 3 h): ≤ 0.2 %
Corresponds to FCC V
Identity (IR-spectrum): passes test
Appearance: white to almost white, fine-crystalline powder
Appearance of solution (100 g/l, hydrochloric acid 2 mol/l): clear and colorless
Spec. rotation (α 20/D, 20 g/l, hydrochloric acid 1 mol/l, previously dried substance): -215 to -225
Heavy metals (as Pb): ≤ 10 ppm
Pb (Lead): ≤ 5 ppm
Ninhydrin - positive substances (LC) (largest single impurity): ≤ 0.2 %
Ninhydrin - positive substances (LC) (Sum of all impurities): ≤ 0.5 %
Sulfated ash (800 °C): ≤ 0.1 %
Loss on drying (105 °C; 3 h): ≤ 0.2 %
Corresponds to FCC V
法的情報
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany
保管分類コード
11 - Combustible Solids
WGK
WGK 1
引火点(°F)
Not applicable
引火点(℃)
Not applicable
試験成績書(COA)
製品のロット番号・バッチ番号を入力して、試験成績書(COA) を検索できます。ロット番号・バッチ番号は、製品ラベルに「Lot」または「Batch」に続いて記載されています。
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