Active ingredient · Urea family

Pharmaceutical analytical standard

Urea

Synonyms: Carbamide, Carbonyldiamide, Ureophil, Carbonyldiamine, Ureaphil, Keratinamin, Urevert, Alphadrate, Aquadrate, Carbaderm, Pastaron, Urepearl, Carbamide resin, Ultra Mide, Varioform ii, Aqua Care, Harnstoff, Mocovina, Nutraplus, Prespersion, 75 urea, Supercel 3000, Aqua Care HP, Ureacin-10 lotion, Ureacin-40 Creme, Caswell No. 902, Antisepsis bolus, Elaqua xx, Sterile Urea, EPA Pesticide Chemical Code 085702, Azodicarboxylic acid-diamide, NSC 34375, INS NO.927A, Lanaphilic, Flexifoot, Flexitol, Protexa, Vanamide, UterCleanse, Xurea, Balneum plus, Umecta Mousse, Sential e, Cem-urea, St.james balm, Urea Foam, Hydromol intensive, Umecta Mousse Urea, Rynoderm, Heel balm, Clean-up, URE-K, Intrauterine bolus, Isourea, Carbamimidic acid, Basodexan, Carmol, Ureacin-20, Panafil, Hyanit, Aminoketone, Ureum, Carbamimic acid, Bubber shet, Keratinamin Kowa, Benural 70, Urea, prilled, Urea, ultra pure, Uree, Isoharnstoff, Cerovel, Karbamid, Urepeal, Uroderm, Urea perhydrate, Pastaron soft, Urepeal L, beta-I-k, Pastaron 10, Pastaron 20, Pastaron 20 soft, Carbonamidimidic acid, Urea, p.a., Optigen 1200, Urea (JP18/USP), Urea, for electrophoresis, Urea, u.s.p., u-cort component urea, Alphaderm component urea, Carmol hc component urea, Urea, Molecular Biology Reagent, Calmurid hc component urea, Pharmakon1600-01500604, Urea, NIST(R) SRM(R) 2141, NSC 757375, Urea, meets USP testing specifications

Cat. No.: P-U011-001
CAS: 57-13-6
Alternative CAS: 37955-36-5 (alternative CAS, same compound)
4744-36-9 (alternative CAS, same compound)
3138-51-0 (alternative CAS, same compound)
Formula: CH₄N₂O
Molecular weight: 60.06 g/mol
Category: Active ingredient (API)

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Characterisation level Level 1 Mass balanceFor small molecules, identity is confirmed by IR, MS, 1H-NMR and 13C-NMR, purity by HPLC (min. 95%) and assay by mass balance (min. 90%); for peptides and similar molecules, identity is confirmed by mass spectrometry (ESI-MS and MALDI-TOF) and IR, purity by HPLC (min. 95%) and assay by mass balance, reported for information only.* Level 2 Mass balance + qNMRFor small molecules, in addition to the Level 1 analyses, the assay is verified by qNMR, an orthogonal method independent of chromatography; for peptides and similar molecules, Level 2 is not available. Analytical documentation supporting qualification as an in-house primary standard under ICH Q7 (§11.17-11.18).

* Mass balance is performed on every molecule. The only exceptions are cases where the chemistry of the molecule prevents it, for example oils and highly volatile substances, on which some of the required measurements cannot be made: in those cases the CoA states how the content was assigned.

Quantity

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We reply within 24 hours with a quote and availability. CoA and SDS with every lot.

The main nitrogen-containing substance in mammalian urine: it is made in the liver through the urea cycle and is how the body gets rid of nitrogen. Over 90% of industrial production becomes fertiliser, and it is also used in moisturising creams.

Did you know?In 1828 Friedrich Wöhler made it in the laboratory from inorganic substances: a result often cited as the starting point of modern organic chemistry.

The two levels compared

	Level 1 Mass balance	Level 2 Mass balance + qNMR
Identity (IR, MS, 1H and 13C-NMR; peptides: ESI-MS, MALDI-TOF and IR)	✓	✓
HPLC purity (min. 95%)	✓	✓
Content by mass balance (min. 90%; peptides: for information only)*	✓	✓
Content verified by qNMR (small molecules only)	·	✓
Suitable to qualify it as an in-house primary standard (ICH Q7)	·	✓

What you receive

The analytical standard

Shipped under controlled temperature when the molecule requires it.

Certificate of analysis (CoA)

For every lot: identity, purity and assay, with the supporting spectra and chromatograms.

Safety data sheet (SDS)

Sent with every order.

Tracked shipment

Follow your shipment live, from our warehouse to your lab.

Pharmacopoeial standards available

The official European Pharmacopoeia standards for this molecule, supplied with EDQM documentation.

UreaBP 350
Urea CRSEP U0600000

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Isotopically labelledN-Nitroso Urea-13CCat. No. P-U011-007

Nitrosamine1-Ethyl-3-(3-(methyl (nitroso)amino)propyl)ureaCat. No. P-U011-008

NitrosamineN-Nitroso UreaCat. No. P-U011-009CAS 13010-20-3

Impurity(2-Aminoethyl) Urea HydrochlorideCat. No. P-U011-010CAS 858001-69-1

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Frequently asked questions

Is mass balance always performed?

Yes, on every molecule. The only exceptions are cases where the chemistry of the molecule prevents it: for example oils and highly volatile substances, on which some measurements (such as thermogravimetry) cannot be made. In those cases the CoA states which method was used to assign the content.

Can I ask for a different quantity?

Yes. The quantities are only suggestions: choose "Other" and enter the milligrams or grams you need.

Which level should I choose?

Level 1 is enough for most routine testing. Level 2 adds an independent qNMR content value and is meant for labs that need to qualify an in-house primary standard. For peptides and similar molecules, Level 2 is not available.

When will I get the quote?

Within 24 working hours, with price, availability and delivery time.

Need a molecule you cannot find?

Custom synthesis of impurities, metabolites and labelled compounds, with the same characterisation level.

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