General description
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.
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.
Analysis Note
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
Legal Information
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany
- UPC:
- 51172200
- Condition:
- New
- Weight:
- 1.00 Ounces
- HazmatClass:
- No
- WeightUOM:
- LB
- MPN:
- 1028361000
