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Key Documents

1.04161

SAFC

Ammonium sulfate

granulated, EMPROVE® EXPERT, ACS, ChP, NF

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:
12352314

grade

GMO free
Halal
Kosher

Quality Level

Agency

ChP
NF

product line

EMPROVE® EXPERT

form

solid

mp

>280 °C (dec.) (lit.)

density

1.77 g/mL at 25 °C (lit.)

application(s)

parenterals
pharma/biopharma processes
pharmaceutical

storage temp.

20-25°C

SMILES string

N.N.OS(O)(=O)=O

InChI

1S/2H3N.H2O4S/c;;1-5(2,3)4/h2*1H3;(H2,1,2,3,4)

InChI key

BFNBIHQBYMNNAN-UHFFFAOYSA-N

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General description

Standard bulk materials often show a tendency for caking, clumping and dust formation which results in laborious weighing and manual de-caking processes with a negative impact on manufacturing efficiency. Due to its granulated form, Ammonium Sulfate granulated is free-flowing and easy to handle. Its greatly reduced caking behavior facilitates processability, speeds up manufacturing processes and increases operator safety.
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.

Packaging

1.04161.0001 / 3x 1 kg / PE bottle
1.04161.1000 / 1 kg / PE bottle
1.04161.9026 / 25 kg / PE bag in PE drum

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.

EU REACH Annex XVII (Restriction List)

CAS No.

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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