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Merck

1.28218

SAFC

Ammonium sulfate

EMPROVE® EXPERT, ChP, NF, ACS

Pharma Manufacturing

Synonym(s):

Mascagnite

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About This Item

Linear Formula:
(NH4)2SO4
CAS Number:
Molecular Weight:
132.14
MDL number:
UNSPSC Code:
12352301

Pricing and availability is not currently available.

grade

ACS reagent

Quality Level

Agency

ChP
NF

vapor pressure

<1 Pa ( 25 °C)

product line

EMPROVE® EXPERT

form

solid

potency

2840 mg/kg LD50, oral (rat)

pH

5 (100 g/L in H2O)

solubility

754-764 g/L

bulk density

850 kg/m3

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1 of 4

This Item
A6926E4267218765
solubility

ethanol: acetic acid (2:1): 50 mg/mL, clear to hazy

solubility

DMF: 1 tablet/5 mL

solubility

1 M NaOH: 9.80-10.20 mg/mL, clear, colorless to faintly yellow

solubility

DMSO: 5 mg/mL

form

powder

form

tablet

form

powder

form

solid

storage temp.

2-8°C

storage temp.

-

storage temp.

2-8°C

storage temp.

−20°C

impurities

≤3% solvent

impurities

-

impurities

-

impurities

-

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

Ammonium sulfate is widely used as a precipitant in biopharma manufacturing and as a excipient in liposomal formulations.
Due to its low microbial and endotoxin limits, Ammonium sulfate 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

13 - Non Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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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Quality Management Dossier (Open Access)

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Operational Excellence Dossier

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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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