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克拉霉素，Clarithromycin [CLM]；Pharmaceutical Secondary Standard; Certified Reference Material

别名：克拉仙；克拉红霉素；6-0-甲基红霉素A；6氧甲基红霉素；甲红霉素；甲氧基红霉素；克红霉素；沃克；甲力；卡碧士；卡斯迈欣；莱欣；利迈先；BIAXIN；Claris； te-03； Clarithromycin；6-0-MethylerythromycinA；Claricid；6-0-MethylerythromycinA；Claricid；Klaricid

Empirical Formula (Hill Notation): C38H69NO13 CAS号: 81103-11-9 分子量: 747.95 MDL编号: MFCD00865140 PubChem化学物质编号: 329823068 NACRES: NA.24

制造商品牌: 西格玛 Sigma-Aldrich , 默克色谱科 Supelco

货号（SKU）: PHR1038

CAS号: 81103-11-9

MDL号: MFCD00865140

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目录价.SKU-Variant

500mg

¥1,260.00

数量:

说明

克拉霉素属于大环内酯红霉素类抗生素。由于克拉霉素具有广谱抗菌活性，已配制出多种剂型的克拉霉素。它被广泛用于治疗衣原体、支原体、军团菌、幽门螺杆菌和鸟分枝杆菌复合物引起的感染。它还被认为对HIV相关的机会性感染有积极作用。
用于质量控制的制药二级标准，为制药实验室和制造商提供了一种方便且成本效益高的替代方案，以替代内部工作标准的制定。

克拉霉素可作为药物参考标准，用于通过超高效液相色谱（UPLC）、高效液相色谱仪（HPLC）和飞行时间二次离子质谱（ToF-SIMS）技术测定药物制剂中的分析物。它可以作为参考标准，使用液相色谱-串联质谱（LC-MS-MS）验证人血浆样品中克拉霉素的浓度。克拉霉素也可用作测试参考标准，使用两种不同类型的方法（定量核磁共振（qNMR）和高效液相色谱（HPLC））验证和比较其纯度。
这些二级标准被认定为合格参考材料。这些适用于多种分析应用，包括但不限于药物释放测试、用于定性和定量分析的药物方法开发、食品和饮料质量控制测试以及其他校准要求。

一般描述

Clarithromycin belongs to the group of macrolide erythromycin antibiotics. Owing to its broad-spectrum antibacterial activity, several dosage forms of clarithromycin have been formulated. It is widely utilized to treat the infections caused by Chlamydia, Mycoplasma, Legionella, Helicobacter pylori, and Mycobacterium avium complex. It is also known to be active against HIV-related opportunistic infections.

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.

应用

Clarithromycin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by ultra-performance liquid chromatography (UPLC), high performance liquid chromatography (HPLC) and time-of-flight-secondary ion mass spectrometry (ToF-SIMS) techniques. It can be used as a reference standard in validating the concentration of clarithromycin in human plasma samples using liquid chromatography coupled with tandem mass spectrometry (LC-MS-MS). Clarithromycin may also be used as a test reference standard to validate and compare its purity using two different types of methods, quantitative nuclear magnetic resonance (qNMR) and high performance liquid chromatography (HPLC).
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.

生化/生理作用

克拉霉素是一种大环内酯类抗生素，能干扰细菌蛋白质的合成。克拉霉素是红霉素的酸稳定形式，对革兰氏阴性细菌特别有效。它的半衰期很短，但是其代谢产物 14-羟基克拉霉素对某些细菌的活性几乎是克拉霉素的两倍。

分析说明

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

其他说明

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.

附注

To see an example of a Certificate of Analysis for this material enter LRAC0293 in the slot below. This is an example certificate only and may not be the lot that you receive.

属性

等级

certified reference material
pharmaceutical secondary standard

质量水平

300

Agency

traceable to BP 833
traceable to Ph. Eur. Y0000320
traceable to USP 1134379

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

格式

neat

储存温度

-10 to -25°C

SMILES string

O[C@@H]([C@@](O)(C)[C@@H](CC)OC([C@H](C)[C@H]1O[C@@H]2O[C@@H](C)[C@H](O)[C@](C)(OC)C2)=O)[C@@H](C)C([C@H](C)C[C@@](C)(OC)[C@H](O[C@@H]3O[C@H](C)C[C@H](N(C)C)[C@H]3O)[C@H]1C)=O

InChI

1S/C38H69NO13/c1-15-26-38(10,45)31(42)21(4)28(40)19(2)17-37(9,47-14)33(52-35-29(41)25(39(11)12)16-20(3)48-35)22(5)30(23(6)34(44)50-26)51-27-18-36(8,46-13)32(43)24(7)49-27/h19-27,29-33,35,41-43,45H,15-18H2,1-14H3/t19-,20-,21+,22+,23-,24+,25+,26-,27+,29-,30+,31-,32+,33-,35+,36-,37-,38-/m1/s1

InChI key

AGOYDEPGAOXOCK-KCBOHYOISA-N

安全信息

象形图

GHS07

警示用语：

Warning

危险声明

H302

预防措施声明

P264 - P270 - P301 + P312 - P501

危险分类

Acute Tox. 4 Oral

储存分类代码

11 - Combustible Solids

WGK

WGK 1

个人防护装备

dust mask type N95 (US), Eyeshields, Gloves

商品规格

属性名称	属性值
储存温度 Storage temp.	常温阴凉避光
全球实时库存 Availability √	美国St. Louis ≥ 99 \| 欧洲Eur. ≥ 10 \| 東京Tokyo ≥ 22 \| 香港与北京 ≥ 32

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