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PHR1703

Natamycin

Name: Natamycin
Brand: SIAL

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Pimaricin, Natamycin

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About This Item

Empirical Formula (Hill Notation):

C₃₃H₄₇NO₁₃

CAS Number:

7681-93-8

Molecular Weight:

665.73

NACRES:

NA.24

PubChem Substance ID:

329823566

UNSPSC Code:

41116107

EC Number:

231-683-5

MDL number:

MFCD00135085

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Properties

Quality Level

300

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

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

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

Description

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.

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.

Biochem/physiol Actions

An antifungal polyene macrolide that binds specifically to ergosterol and blocks fungal growth. However, unlike nysatin and filipin, pimaricin does not change the permeability of the plasma membrane

Analysis Note

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

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.

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Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

涉药品监管产品

This item has

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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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)

Global Trade Item Number

SKU	GTIN
PHR1703-1G	04061835238200