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Key Documents

Safety Information

1.01791

SAFC

L-Glutamic acid

EMPROVE® EXPERT, Ph. Eur., JP, USP

Pharma Manufacturing

Synonym(s):

L-Glutamic acid, L-α-Aminoglutaric acid, Glu, L-alpha-Aminoglutaric acid

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About This Item

CAS Number:
Molecular Weight:
147.13
MDL number:
UNSPSC Code:
12352209
EC Index Number:
200-293-7

Agency

JP
Ph. Eur.
USP
suitable for SM 5210

Quality Level

product line

EMPROVE® EXPERT

Assay

99.0-100.5% dry basis (alkalimetric)

form

solid

potency

>30000 mg/kg LD50, oral (Rat)

pH

3.0-3.5 (25 °C, 8.6 g/L in H2O)

mp

160 °C

solubility

11.1 g/L

density

1.54 g/cm3 at 20 °C

bulk density

460 kg/m3

anion traces

chloride (Cl-): ≤200 ppm
sulfate (SO42-): ≤200 ppm

cation traces

Fe: ≤10 ppm
NH4+: ≤200 ppm
heavy metals (as Pb): ≤10 ppm

storage temp.

2-30°C

InChI

1S/C5H9NO4/c6-3(5(9)10)1-2-4(7)8/h3H,1-2,6H2,(H,7,8)(H,9,10)

InChI key

WHUUTDBJXJRKMK-UHFFFAOYSA-N

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 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.

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


Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

JAN Code

1017919025:
1017910000:
1017911003:
US11017911000A:
1017911000:
1017919010:
1.01791.1000A:


Certificates of Analysis (COA)

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