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Key Documents

1.08432

SAFC

Urea

crystalline, EMPROVE® API, Ph. Eur., BP, USP

Pharma Manufacturing

Synonym(s):

Carbamide, Carbonyl diamide, Carbonyldiamine, Diaminomethanone, Carbonyldiamide

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About This Item

Linear Formula:
NH2CONH2
CAS Number:
Molecular Weight:
60.06
Beilstein/REAXYS Number:
635724
MDL number:
EC Index Number:
200-315-5

biological source

synthetic

Quality Level

grade

GMO free
GMP
Halal
Kosher

agency

BP
Ph. Eur.
USP

product line

EMPROVE® API

form

crystalline

impurities

low in endotoxins

mp

132-135 °C (lit.)

density

1.335 g/mL at 25 °C (lit.)

application(s)

ophthalmics
pharmaceutical
semi-solid formulation

foreign activity

Aflatoxin free

storage temp.

2-25°C

SMILES string

NC(N)=O

InChI

1S/CH4N2O/c2-1(3)4/h(H4,2,3,4)

InChI key

XSQUKJJJFZCRTK-UHFFFAOYSA-N

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General description

We provide industry-leading production know-how and comprehensive regulatory support for high-quality APIs, backed by nearly 200 years of experience. From a complete portfolio of innovative folates to custom synthesis, our customized and scalable solutions meet your specific production needs.
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

Urea as an active pharmaceutical ingedient is used mainly in dermatology for cremes and ointments and for ophthalmic applications. Urea crystalline Emprove® API is manufactured under ICH Q7. A CEP and an US-DMF is available.
Used for the denaturation of proteins and as a mild solubilization agent for insoluble or denatured proteins. Useful for renaturing proteins from samples already denatured with 6 M guanidine chloride such as inclusion bodies. May be used with guanidine hydrochloride and dithiothreitrol (DTT) in the refolding of denatured proteins into their native or active form.

Packaging

1.08432.0001 // 3x 1kg // PE bottle
1.08432.1000 // 1kg // PE bottle
1.08432.5000 // 5kg // PE bottle
1.08432.9029 // 25 kg //Double PE bag

Legal Information

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

Storage Class

11 - Combustible Solids

wgk_germany

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable


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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