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Merck

1.00366

SAFC

(S)-Lactic acid

about 90%, EMPROVE® EXPERT, Ph. Eur., BP, E 270

Pharma Manufacturing

Synonym(s):

L-(+)-Lactic acid, 2-Hydroxypropionic acid, Lactol, (S)-2-Hydroxypropionic acid, Sarcolactic acid

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About This Item

Empirical Formula (Hill Notation):
C3H6O3
CAS Number:
Molecular Weight:
90.08
Beilstein:
1720251
MDL number:
UNSPSC Code:
12352106
E Number:
E270

Agency

BP
Ph. Eur.

Quality Level

vapor pressure

0.1 hPa ( 25 °C)

product line

EMPROVE® EXPERT

form

liquid

concentration

90%

technique(s)

API processing | cocrystal formation: suitable
API processing | salt formation: suitable

pH

2.8 (20 °C, 10 g/L in H2O)

bp

122 °C/20 hPa

mp

18 °C

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General description

Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge in formulation. 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 biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

Application

Lactic acid is used as an acidifying agent in a oral, topical and parenteral formulations.
Due to its low microbial and endotoxin limits, (S)-Lactic acid about 90% Emprove® Expert is especially suitable for high-risk applications.

Legal Information

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

Pictograms

Corrosion

Signal Word

Danger

Hazard Statements

Hazard Classifications

Eye Dam. 1 - Skin Corr. 1C

Supplementary Hazards

Storage Class Code

8A - Combustible corrosive hazardous materials

WGK

WGK 1


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. Four document types are included with an Emprove® Program subscription:

Material Qualification Dossier

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Quality Management Dossier (Open Access)

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Operational Excellence Dossier

Available by subscription or for a fee

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Why are these documents unavailable?
Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.

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