MilliporeSigma
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1.07647

SAFC

L-Serine

EMPROVE® EXPERT Ph Eur,USP

Synonym(s):
3-Hydroxy-L-alanine, Ser, L-Serine
CAS Number:
Molecular Weight:
105.09
MDL number:
EC Index Number:
200-274-3

Quality Level

Agency

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

General description

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 BY₆Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 2 mol/l, calc. on dried substance)+14.0 to +16.0Spec. rotation (α 25/D, 100 g/l, hydrochloric acid 2 mol/l, calc. on dried substance)+14.0 to +15.6Chloride (Cl)≤ 200 ppmSulfate (SO₄)≤ 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; 3 h)≤ 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.

Other Notes

Due to its low microbial and endotoxin limits, L-Serine Emprove® Expert is suitable for biopharma manufacturing needs.

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

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Certificate of Quality

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What is the Emprove® Program?

The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials.

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