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