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Merck
CN

PHR1737

Colistimethate Sodium

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

Colistimethate sodium, CMS, Colistin sulphomethate sodium

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化学文摘社编号:
8068-28-8
UNSPSC Code:
41116107
EC Number:
232-516-9
NACRES:
NA.24

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Quality Level

300

SMILES string

[Na+].[Na+].[Na+].[Na+].[Na+].[S](=O)(=O)([O-])CNCCC1NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(CCNC(=O)C(NC1=O)C(O)C)NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)CCCCC(CC)C)CCNC[S](=O)(=O)[O-])C(O)C)CCNC[S](=O)(=O)[O-])CCNC[S](=O)(=O)[O-])CC(C)C)CC(C)C)CCNC[S](=O)(=O)[O-]

InChI key

IQWHCHZFYPIVRV-UHFFFAOYSA-I

InChI

1S/C58H110N16O28S5.5Na/c1-9-35(6)12-10-11-13-46(77)65-38(14-20-59-28-103(88,89)90)53(82)74-48(37(8)76)58(87)70-41(17-23-62-31-106(97,98)99)50(79)68-43-19-25-64-57(86)47(36(7)75)73-54(83)42(18-24-63-32-107(100,101)102)67-49(78)39(15-21-60-29-104(91,92)93)69-55(84)44(26-33(2)3)72-56(85)45(27-34(4)5)71-52(81)40(66-51(43)80)16-22-61-30-105(94,95)96;;;;;/h33-45,47-48,59-63,75-76H,9-32H2,1-8H3,(H,64,86)(H,65,77)(H,66,80)(H,67,78)(H,68,79)(H,69,84)(H,70,87)(H,71,81)(H,72,85)(H,73,83)(H,74,82)(H,88,89,90)(H,91,92,93)(H,94,95,96)(H,97,98,99)(H,100,101,102);;;;;/q;5*+1/p-5

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. C2600000, traceable to USP 1147009

API family

colistimethate

CofA

current certificate can be downloaded

packaging

pkg of 500 mg

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

-10 to -25°C

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相关类别

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.
Colistimethate Sodium belongs to the class of polymyxin antibiotics that acts by inhibiting the Gram negative bacteria. It is a prodrug that can hydrolyze to colistin in vivo or in vitro. It is employed as a last resort antibiotic to treat Pseudomonas aeruginosa infection in cystic fibrosis patients.

Application

Colistimethate Sodium may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by 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.

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 LRAA8043 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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A simple method for assaying colistimethate sodium in pharmaceutical aerosol samples using high performance liquid chromatography
Metcalf AP, et al.
Journal of Pharmaceutical and Biomedical Analysis, 142, 15-18 (2017)

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