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Merck

PHR1378

Supelco

レフルノミド

Pharmaceutical Secondary Standard; Certified Reference Material

別名:

レフルノミド, 5-メチルイソオキサゾール-4-(4-トリフルオロメチル)カルボキシアニリド

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About This Item

実験式(ヒル表記法):
C12H9F3N2O2
CAS番号:
分子量:
270.21
MDL番号:
UNSPSCコード:
41116107
PubChem Substance ID:
NACRES:
NA.24

グレード

certified reference material
pharmaceutical secondary standard

品質水準

認証

traceable to Ph. Eur. Y0000654
traceable to USP 1356960

APIファミリー

leflunomide

CofA

current certificate can be downloaded

テクニック

HPLC: suitable
gas chromatography (GC): suitable

アプリケーション

pharmaceutical (small molecule)

フォーマット

neat

保管温度

2-8°C

SMILES記法

Cc1oncc1C(=O)Nc2ccc(cc2)C(F)(F)F

InChI

1S/C12H9F3N2O2/c1-7-10(6-16-19-7)11(18)17-9-4-2-8(3-5-9)12(13,14)15/h2-6H,1H3,(H,17,18)

InChI Key

VHOGYURTWQBHIL-UHFFFAOYSA-N

遺伝子情報

human ... DHODH(1723)

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詳細

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. Leflunomide belongs to the new class of immunomodulating drugs with inflammatory and immunomodulating properties. It has been investigated for application in transplantation procedures. It is also an anti-rheumatic drug (DMARD) used to treat rheumatoid arthritis (RA). Its mode of action involves the inhibition of T-cell proliferation after converting to its active metabolite i.e. A771726 in humans.

アプリケーション

Leflunomide may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using chromatography 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.

アナリシスノート

このような2次標準は、USP、EP(PhEur)、BPの1次標準にマルチトレーサビリティを提供します。

その他情報

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.

脚注

To see an example of a Certificate of Analysis for this material enter LRAA1634 in the slot below. This is an example certificate only and may not be the lot that you receive.

ピクトグラム

Skull and crossbones

シグナルワード

Danger

危険有害性情報

危険有害性の分類

Acute Tox. 3 Oral - Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3

ターゲットの組織

Respiratory system

保管分類コード

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK

WGK 1

引火点(°F)

Not applicable

引火点(℃)

Not applicable


適用法令

試験研究用途を考慮した関連法令を主に挙げております。化学物質以外については、一部の情報のみ提供しています。 製品を安全かつ合法的に使用することは、使用者の義務です。最新情報により修正される場合があります。WEBの反映には時間を要することがあるため、適宜SDSをご参照ください。

Jan Code

PHR1378-1G:
PHR1378-1G-PW:


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試験成績書(COA)

Lot/Batch Number

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Development and Validation of a liquid chromatographic method for the determination of leflunomide: application to in vitro drug metal interactions
Sultana N, et al.
Chin. J. Chem., 29(9), 1933-1938 (2011)
Development of liquid chromatography?UV method for simultaneous determination of leflunomide and NSAIDS in API and pharmaceutical formulations: its application to in vitro interaction studies
Sultana N, et al.
Medicinal Chemistry, 3, 262-270 (2013)
Nicola Alcorn et al.
Drug safety, 32(12), 1123-1134 (2009-11-18)
Evidence is accumulating for the early sustained usage of disease-modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis. Leflunomide was licensed for the treatment of rheumatoid arthritis in 1998. Postmarketing surveillance, case reports and observational studies have highlighted less common or unexpected
W James Chon et al.
Expert review of clinical immunology, 7(3), 273-281 (2011-05-21)
Leflunomide is a synthetic isoxazole-derivative drug that possesses both immunosuppressive and antiviral properties. Although its only US FDA-approved indication is for the treatment of rheumatoid arthritis, accumulating clinical experience in addition to animal study data makes it an appealing option
Frank Behrens et al.
Current opinion in rheumatology, 23(3), 282-287 (2011-03-24)
Leflunomide is often used as a first choice disease-modifying antirheumatic drug after methotrexate. New data are available for efficacy and safety in both, monotherapy and combination with biologicals. New data on efficacy demonstrate comparable effect sizes for leflunomide and methotrexate

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