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Safety Information

1.06522

SAFC

Sodium-(S)-lactate-solution

about 50%, EMPROVE® EXPERT, Ph. Eur., BP, USP

Pharma Manufacturing

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About This Item

UNSPSC Code:
12352107
Pricing and availability is not currently available.

Agency

BP
Ph. Eur.
USP

Quality Level

500

product line

EMPROVE® EXPERT

form

liquid

concentration

50%

pH

6.5-9.0 ( in H2O)

bp

109 °C/1013 hPa

density

1.263 g/cm3 at 20 °C

application(s)

liquid formulation
parenterals
pharma/biopharma processes
pharmaceutical
semi-solid formulation

storage temp.

15-25°C

Related Categories

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

Sodium lactate is typically used as preservative, pH adjuster, and bulking agent in pharmaceutical formulations. It is also used as preservative in food industry.
Due to its low microbial and endotoxin limits, Sodium-(S)-lactate-solution about 50% 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

Storage Class Code

12 - Non Combustible Liquids

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

1065222500:
1065229999:
1065222500BWT:
1065229019:
1065229901:
1065220000:

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

Free of charge - Sign in to download

Quality Management Dossier (Open Access)

Free of charge - Sign in to download

Operational Excellence Dossier

Available by subscription or for a fee

Operational Excellence Dossier

Available by subscription or for a fee

Learn more about the benefits an Emprove® Program subscription can provide
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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