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Key Documents

PHR1365

Supelco

Lamivudine

Pharmaceutical Secondary Standard; Certified Reference Material

Sinonimo/i:

Lamivudine, 2′,3′-Dideoxy-3′-thiacytidine, 3TC, Epivir, Epivir-HBV, Heptovir, Zeffix

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About This Item

Formula empirica (notazione di Hill):
C8H11N3O3S
Numero CAS:
Peso molecolare:
229.26
Numero MDL:
Codice UNSPSC:
41116107
ID PubChem:
NACRES:
NA.24

Grado

certified reference material
pharmaceutical secondary standard

Livello qualitativo

agenzia

traceable to BP 802
traceable to Ph. Eur. Y0000425
traceable to USP 1356836

Famiglia di API

lamivudine

CdA

current certificate can be downloaded

tecniche

HPLC: suitable
gas chromatography (GC): suitable

applicazioni

pharmaceutical (small molecule)

Formato

neat

Temperatura di conservazione

2-8°C

Stringa SMILE

NC1=NC(=O)N(C=C1)[C@@H]2CS[C@H](CO)O2

InChI

1S/C8H11N3O3S/c9-5-1-2-11(8(13)10-5)6-4-15-7(3-12)14-6/h1-2,6-7,12H,3-4H2,(H2,9,10,13)/t6-,7+/m0/s1
JTEGQNOMFQHVDC-NKWVEPMBSA-N

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Descrizione generale

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.
Lamivudine is a synthetic nucleoside analog that shows potential action against human immunodeficiency virus (HIV). It is one of the front line therapies used to treat HIV infection.

Applicazioni

Lamivudine may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and serum samples by chromatography and spectrophotometry techniques.
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.

Azioni biochim/fisiol

Lamivudine is a potent nucleoside analog reverse transcriptase inhibitor (nRTI). It is an analogue of cytidine, and can inhibit both types (1 and 2) of HIV reverse transcriptase as well as the reverse transcriptase of hepatitis B. It needs to be phosphorylated to its triphosphate form before it is active. 3TC-triphosphate also inhibits cellular DNA polymerase.

Risultati analitici

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

Altre note

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.

Nota a piè di pagina

To see an example of a Certificate of Analysis for this material enter LRAA1469 in the slot below. This is an example certificate only and may not be the lot that you receive.

Prodotti consigliati

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.

Pittogrammi

Health hazard

Avvertenze

Warning

Indicazioni di pericolo

Consigli di prudenza

Classi di pericolo

Repr. 2

Codice della classe di stoccaggio

11 - Combustible Solids

Classe di pericolosità dell'acqua (WGK)

WGK 3

Punto d’infiammabilità (°F)

Not applicable

Punto d’infiammabilità (°C)

Not applicable


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Certificati d'analisi (COA)

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Determination of lamivudine and zidovudine in binary mixtures using first derivative spectrophotometric, first derivative of the ratio-spectra and high-performance liquid chromatography-UV methods
Uslu B and Ozkan SA
Analytica Chimica Acta, 466(1), 175-185 (2002)
Simultaneous determination of lamivudine and stavudine in antiretroviral fixed dose combinations by first derivative spectrophotometry and high performance liquid chromatography
Kapoor N, et al.
Journal of Pharmaceutical and Biomedical Analysis, 41(3), 761-765 (2006)
Simultaneous separation and determination of lamivudine and zidovudine in pharmaceutical formulations using the HPTLC method
Habte G, et al.
Analytical Letters, 42(11), 1552-1570 (2009)
Simultaneous determination of zidovudine and lamivudine in human serum using HPLC with tandem mass spectrometry
Kenney KB, et al.
Journal of Pharmaceutical and Biomedical Analysis, 22(6), 967-983 (2000)
Youwen Tan et al.
PloS one, 7(3), e32789-e32789 (2012-04-06)
Several recent reports have demonstrated that tyrosine (Y)-methionine (M)-aspartic acid (D)-aspartic acid (D) (YMDD) motif mutations can naturally occur in chronic HBV patients without antiviral treatment such as lamivudine therapy. This paper aims to assess the overall spontaneous incidence and

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