L-Serine
CAS Number: | 56-45-1 |
Molecular Weight: | 105.09 |
MDL number: | MFCD00064224 |
EC Index Number: | 200-274-3 |
Кат. номер |
1076479010 |
1076470000 |
1076471000 |
1.07647.1000 |
Finding the right chemical that matches your pharma and biopharma manufacturing needs as well as regulatory demands can be a complicated challenge. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for pharma and biopharma manufacturing withstands strict quality control procedures and is produced according to applicable cGMP guidelines.
Analysis Note
Assay (perchloric acid titration, calculated on dried substance)98.5 - 101.0 %Identity (IR-spectrum)passes testIdentity (specific rotation)passes testAppearancewhite to almost white or colorless, needle-shaped crystalsAppearance of solution (50 g/l; water)clear and not more intense in color than reference solution BYSpec. rotation ( 20/D, 100g/l, hydrochloric acid 2mol/l, calc. on dried substance)+14.0 to +16.0Spec. rotation ( 25/D, 100g/l, hydrochloric acid 2mol/l, calc. on dried substance)+14.0 to +15.6Chloride (Cl) 200 ppmSulfate (SO) 300 ppmCo (Cobalt) 0.5 ppmCu(Copper) 25 ppmFe (Iron) 10 ppmMn (Manganese) 25 ppmMo (Molybdenum) 2.5 ppmZn (Zinc) 130 ppmRelated Compounds, total (TLC) 0.5 %Ninhydrin-positive substances (LC)(any ninhydrin-positive impurity) 0.2 %Ninhydrin-positive substances (LC) (ammonium (570 nm)) 0.02 %Ninhydrin-positive substances (LC)(total impurities) 0.5 %Methanol (HS-GC) 3000 ppmOther residual solvents (ICH Q3C)excluded by manufacturing processSulfated ash (600°C) 0.1 %Loss on drying (105 °C; 3h) 0.2 %Bacterial endotoxins 2.0 I.U./gTotal aerobic microbial count (TAMC) 100 CFU/gTotal combined yeasts/moulds count (TYMC) 100 CFU/gElemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).Corresponds to Ph.Eur., USP.
Due to its low microbial and endotoxin limits, L-Serine Emprove® Expert is suitable for biopharma manufacturing needs.
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany
storage conditions | Store at +5°C to +30°C. |
Quality Level | 500, |
Agency/Method | JP, Ph. Eur., USP |
product line | EMPROVE® EXPERT |
form | crystalline powder |
pH | 5-6 (20 °C, 100 g/L in H2O) |
mp | 215-225 °C (decomposes) |
solubility | 360 g/L |
bulk density | 570 kg/m3 |
storage temp. | 2-30°C |
InChI | 1S/C3H7NO3/c4-2(1-5)3(6)7/h2,5H,1,4H2,(H,6,7) |
InChI key | MTCFGRXMJLQNBG-UHFFFAOYSA-N |