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Phenylbutyrate EP Impurity B
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Highly Characterized Analytical Standard

Pharmacopoeial impurity · Phenylbutyrate family

Pharmaceutical analytical standard

Phenylbutyrate EP Impurity B

Synonyms: 1-Tetralone, 3,4-dihydro-2H-naphthalen-1-one, alpha-Tetralone, Tetralone, NSC 5171, Cyclohexene,1-one,2,3-benzo, a-Tetralone

Cat. No.
P-P092-003
CAS
529-34-0
Alternative CAS
  • 29059-07-2 (alternative CAS, same compound)
Formula
C10H10O
Molecular weight
146.19 g/mol
Category
Pharmacopoeial impurity (EP/USP)

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Characterisation level

* 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
Talk to a specialist

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

Family: Phenylbutyrate

An aromatic fatty acid, used as its sodium salt and approved in the United States in 1996 for urea cycle disorders: in the body it becomes phenylacetate, which binds the nitrogen of glutamine and has it excreted in the urine instead of urea.

Did you know?The alternative nitrogen disposal pathway was discovered in the early 1980s at Johns Hopkins by Saul Brusilow and Mark Batshaw: phenylbutyrate replaced phenylacetate because, unlike it, it lacks an unpleasant smell.

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)·✓

* 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.

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.

More products in the Phenylbutyrate family

See all 5 products in the family

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.