1.07647
L-Serine
EMPROVE® EXPERT Ph Eur,USP
Fabrication pharma
Synonyme(s) :
L-Serine, 3-Hydroxy-L-alanine, Ser
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About This Item
Numéro CAS:
Poids moléculaire :
105.09
Numéro MDL:
Code UNSPSC :
12352209
Numéro de classement CE :
200-274-3
Produits recommandés
Agence
JP
Ph. Eur.
USP
Niveau de qualité
Gamme de produits
EMPROVE® EXPERT
Forme
crystalline powder
pH
5-6 (20 °C, 100 g/L in H2O)
Pf
215-225 °C (decomposes)
Solubilité
360 g/L
Masse volumique apparente
570 kg/m3
Application(s)
parenterals
Température de stockage
2-30°C
InChI
1S/C3H7NO3/c4-2(1-5)3(6)7/h2,5H,1,4H2,(H,6,7)
Clé InChI
MTCFGRXMJLQNBG-UHFFFAOYSA-N
Description générale
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.
Our SAFC® portfolio of high-quality products for biopharmaceutical processing withstands strict quality control procedures and is produced according to MQ-500 requirements as defined by the M-Clarity program.
M-Clarity Program
As part of our EMPROVE® Program, our raw materials are offered with EMPROVE® Dossiers which provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.
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
As part of our EMPROVE® Program, our raw materials are offered with EMPROVE® Dossiers which provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.
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.
Remarque sur l'analyse
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.
Autres remarques
Due to its low microbial and endotoxin limits, L-Serine Emprove® Expert is suitable for biopharma manufacturing needs.
Informations légales
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany
Code de la classe de stockage
11 - Combustible Solids
Classe de danger pour l'eau (WGK)
WGK 1
Point d'éclair (°F)
Not applicable
Point d'éclair (°C)
Not applicable
Certificats d'analyse (COA)
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