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Merck
CN

PHR1703

纳他霉素

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

游霉素, 那他霉素

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关于此项目

经验公式（希尔记法）:
C33H47NO13
化学文摘社编号:
7681-93-8
分子量:
665.73
NACRES:
NA.24
PubChem Substance ID:
329823566
UNSPSC Code:
41116107
EC Number:
231-683-5
MDL number:
MFCD00135085

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产品名称

纳他霉素, Pharmaceutical Secondary Standard; Certified Reference Material

InChI

1S/C33H47NO13/c1-18-10-8-6-4-3-5-7-9-11-21(45-32-30(39)28(34)29(38)19(2)44-32)15-25-27(31(40)41)22(36)17-33(42,47-25)16-20(35)14-24-23(46-24)12-13-26(37)43-18/h3-9,11-13,18-25,27-30,32,35-36,38-39,42H,10,14-17,34H2,1-2H3,(H,40,41)/b4-3+,7-5+,8-6+,11-9+,13-12+/t18-,19-,20+,21+,22+,23-,24-,25+,27-,28+,29-,30+,32+,33-/m1/s1

InChI key

NCXMLFZGDNKEPB-FFPOYIOWSA-N

SMILES string

C[C@@H]1C\C=C\C=C\C=C\C=C\[C@@H](C[C@@H]2O[C@](O)(C[C@@H](O)C[C@H]3O[C@@H]3\C=C\C(=O)O1)C[C@H](O)[C@H]2C(O)=O)O[C@@H]4O[C@H](C)[C@@H](O)[C@H](N)[C@@H]4O

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to USP 1457505

API family

natamycin

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

-10 to -25°C

Quality Level

300

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相关类别

Biochem/physiol Actions

与麦角固醇特异性结合并阻止真菌生长的抗真菌多烯大环内脂。但不同于制霉菌素和菲律宾菌素不同，那他霉素不会改变细胞质膜的渗透性

Analysis Note

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

Application

Natamycin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by high-performance liquid chromatography coupled with tandem mass spectrometry (LC−MS/MS).
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

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.
Natamycin is a major drug that is utilized in the treatment of fungal keratitis. It is, by far, the only available approved antifungal drug for the said purpose by the U.S. Food and Drug Administration.

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 LRAC2803 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

存储类别

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

法规信息

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Bioanalytical method development and validation of natamycin in rabbit tears and its application to ocular pharmacokinetic studies.
Bhatta RS, et al.
Journal of Pharmaceutical and Biomedical Analysis, 54(5), 1096-1100 (2011)

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