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Merck

PHR1323

L-Cystine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

L-Cystine, (R,R)-3,3′-Dithiobis(2-aminopropionic acid)

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About This Item

Linear Formula:
[-SCH2CH(NH2)CO2H]2
CAS Number:
56-89-3
Molecular Weight:
240.30
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823308
EC Number:
200-296-3
Beilstein/REAXYS Number:
1728094
MDL number:
MFCD00064228

Key Documents

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Product Name

L-Cystine, Pharmaceutical Secondary Standard; Certified Reference Material

SMILES string

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

InChI key

LEVWYRKDKASIDU-IMJSIDKUSA-N

InChI

1S/C6H12N2O4S2/c7-3(5(9)10)1-13-14-2-4(8)6(11)12/h3-4H,1-2,7-8H2,(H,9,10)(H,11,12)/t3-,4-/m0/s1

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. C3300000
traceable to USP 1161586

API family

cystine

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

>240 °C (dec.) (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

Quality Level

300

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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.
To see an example of a Certificate of Analysis for this material enter LRAC3784 in the slot below. This is an example certificate only and may not be the lot that you receive.

Analysis Note

These secondary standards offer multi-traceability to the US and EP primary standards, where they are available.

Application

L-Cysteine may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations by chromatography.
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.

General description

L-Cysteine a sulfur-containing, proteingenic non-essential amino acid useful in numerous biological applications.
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.

Storage Class

11 - Combustible Solids

wgk

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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l-Cysteine
Nonvitamin and Nonmineral Nutritional Supplements, 59(11), 53-58 (2019)
Simultaneous identification and determination of total content of aminoacids in food supplements-tablets by gas chromatography
Obreshkova DP, et al.
Asian journal of experimental biological sciences, 5, 57-68 (2012)
Determination of cysteine in pharmaceuticals via liquid chromatography with postcolumn derivatization
Jenke DR and Brown DS
Analytical Chemistry, 59(11), 1509-1512 (1987)
Quantitative analysis of N-acetylcysteine and its pharmacopeial impurities in a pharmaceutical formulation by liquid chromatography-UV detection-mass spectrometry.
Toussaint B,
Journal of Chromatography A, 896(1-2), 191-199 (2000)
Martijn J Wilmer et al.
American journal of physiology. Renal physiology, 299(5), F905-F916 (2010-09-10)
Renal proximal tubules are highly sensitive to ischemic and toxic insults and are affected in diverse genetic disorders, of which nephropathic cystinosis is the most common. The disease is caused by mutations in the CTNS gene, encoding the lysosomal cystine
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