MilliporeSigma

1.08378

SAFC

L-Tyrosine

EMPROVE® EXPERT Ph Eur,JP,USP

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Synonym(s):
L-Tyrosine, 4-Hydroxyphenylalanine, Tyr
CAS Number:
Molecular Weight:
181.19
MDL number:
EC Index Number:
200-460-4

Agency

JP
Ph. Eur.
USP

Quality Level

product line

EMPROVE® EXPERT

potency

>5110 mg/kg LD50, oral (Rat)

pH

6.5 (0.1 g/L in H2O)

mp

297-298 °C (decomposition)

solubility

0.38 g/L

density

1.46 g/cm3 at 20 °C

bulk density

300 kg/m3

application(s)

parenterals

storage temp.

2-30°C

InChI

1S/C9H11NO3/c10-8(9(12)13)5-6-1-3-7(11)4-2-6/h1-4,8,11H,5,10H2,(H,12,13)

InChI key

OUYCCCASQSFEME-UHFFFAOYSA-N

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This Item
1.083961.050201.07267
L-Tyrosine EMPROVE® EXPERT Ph Eur,JP,USP

SAFC

1.08378

L-Tyrosine

L-Tryptophan EMPROVE® EXPERT, Ph. Eur., BP, JP, USP

SAFC

1.08396

L-Tryptophan

L-Leucine EMPROVE® EXPERT Ph Eur,USP

SAFC

1.05020

L-Leucine

L-Phenylalanine EMPROVE® EXPERT Ph Eur,USP

SAFC

1.07267

L-Phenylalanine

mp

297-298 °C (decomposition)

mp

290 °C (decomposition)

mp

270-340 °C (decomposition)

mp

275-283 °C (decomposition)

solubility

0.38 g/L

solubility

10 g/L

solubility

18.9 g/L

solubility

27 g/L

storage temp.

2-30°C

storage temp.

2-30°C

storage temp.

2-30°C

storage temp.

2-30°C

Quality Level

500

Quality Level

500

Quality Level

500

Quality Level

500

agency

JP

agency

BP, JP, Ph. Eur., USP

agency

Ph. Eur., USP

agency

Ph. Eur., USP

General description

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 ProgramAs 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.

Analysis Note

Assay (perchloric acid titration, calculated on dried substance)99.0 - 101.0 %Identity (IR-spectrum)passes testIdentity (specific rotation)passes testAppearancewhite to almost white, crystalline powder or colorless crystalsAppearance of solution(25 g/l, Hydrochloric acid 2 mol/l)clear and not more intense in color than reference solution Y₇Spec. rotation (α 20/D, 50 g/l, hydrochloric acid 1 mol/l, calc. on dried substance)-11.0 to -12.3Spec. rotation (α 25/D, 50 g/l, hydrochloric acid 1 mol/l, calc. on dried substance)-9.8 to -11.2Chloride (Cl)≤ 200 ppmSulfate (SO₄)≤ 300 ppmFe (Iron)≤ 10 ppmRelated Compounds, total (TLC)≤ 0.5 %Ninhydrin-positive substances (LC)(impurity A (570 nm))≤ 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)≤ 0.6 %Residual solvents (ICH (Q3C))excluded by manufacturing processSulfated ash (600 °C)≤ 0.1 %Loss on drying (105 °C; 3 h)≤ 0.3 %Bacterial endotoxins≤ 20 I.U./gMicrobiological test (total aerobic microbial count (TAMC))≤ 100 CFU/gMicrobiological test (total yeast and mould 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

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


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