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Key Documents

PHR1105

Supelco

L-Leucine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

(S)-2-Amino-4-methylpentanoic acid

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About This Item

Linear Formula:
(CH3)2CHCH2CH(NH2)CO2H
CAS Number:
Molecular Weight:
131.17
Beilstein/REAXYS Number:
1721722
EC Number:
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

agency

traceable to Ph. Eur. L0375000
traceable to USP 1357001

API family

leucine

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

>300 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

CC(C)C[C@H](N)C(O)=O

InChI

1S/C6H13NO2/c1-4(2)3-5(7)6(8)9/h4-5H,3,7H2,1-2H3,(H,8,9)/t5-/m0/s1

InChI key

ROHFNLRQFUQHCH-YFKPBYRVSA-N

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General description

Leucine is a non-glucogenic, essential amino acid and a structural component of proteins.
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

L-Leucine may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using high-performance liquid chromatography technique.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA6929 in the slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Storage Class

11 - Combustible Solids

wgk_germany

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable


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HPLC-fluorescence determination of amino acids in pharmaceuticals after pre-column derivatization with phanquinone
Gatti.R, et al.
Journal of Pharmaceutical and Biomedical Analysis, 35(2), 339-348 (2004)
M Sakamoto et al.
The Journal of clinical endocrinology and metabolism, 56(1), 202-204 (1983-01-01)
Recent studies on the nucleotide sequence of cloned DNA complementary to mRNA for preproenkephalin from bovine adrenal medulla and human pheochromocytoma have revealed that this precursor molecule contains four copies of methionine-enkephalin (Met-Enk) and one copy each of leucine-enkephalin (Leu-Enk)
T Yoshimasa et al.
The Journal of clinical investigation, 69(3), 643-650 (1982-03-01)
To elucidate the physiological and pathophysiological significance of methionine- and leucine-enkephalin (Met-and Leu-enkephalin, respectively) in human sympathoadrenal system, the contents of these peptides in normal human sympathetic nervous system, adrenal medulla, and pheochromocytomas were determined by specific radioimmunoassays combined with
Marika Leenders et al.
Nutrition reviews, 69(11), 675-689 (2011-10-28)
Amino acids function as precursors for de novo protein synthesis. In addition, however, they play a key role as nutritional signals that regulate multiple cellular processes. There is ample in vitro and in vivo evidence showing that muscle tissue responds
Luc J C van Loon
Current opinion in clinical nutrition and metabolic care, 15(1), 71-77 (2011-11-01)
Amino acids do not merely represent precursors for de-novo protein synthesis, but also function as nutritional signals regulating various metabolic processes. In fact, ample evidence has been generated to show that various tissues respond to changes in amino acid availability

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