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PHR1595

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Polymyxin B Sulfate

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Polymyxin B sulfate
CAS Number:
1405-20-5
EC Number:
215-774-7
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to BP 1028
traceable to Ph. Eur. P2400000
traceable to USP 1547007

API family

polymyxin

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.

2-8°C

InChI

1S/C48H82N16O13.H2O4S/c1-27(2)24-37-47(76)59-32(11-19-52)41(70)56-31(10-18-51)43(72)61-35(14-22-65)39(68)54-21-13-34(45(74)57-33(12-20-53)44(73)64-38(48(77)63-37)25-28-6-4-3-5-7-28)60-42(71)30(9-17-50)58-46(75)36(15-23-66)62-40(69)29(8-16-49)55-26-67;1-5(2,3)4/h3-7,26-27,29-38,65-66H,8-25,49-53H2,1-2H3,(H,54,68)(H,55,67)(H,56,70)(H,57,74)(H,58,75)(H,59,76)(H,60,71)(H,61,72)(H,62,69)(H,63,77)(H,64,73);(H2,1,2,3,4)

InChI key

HNDFYNOVSOOGDU-UHFFFAOYSA-N

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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.
Polymyxin B Sulfate is used for the treatment of gram-negative bacterial infections caused particularly by Pseudomonas aeruginosa and Escherichia coli.

Application

Polymyxin B Sulfate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by liquid chromatography and capillary electrophoresis, respectively.
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, EP and BP 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.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC0300 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation mark
GHS07

Signal Word

Warning

Hazard Statements

H302

Precautionary Statements

P264 - P270 - P301 + P312 - P501

Hazard Classifications

Acute Tox. 4 Oral

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

监管及禁止进口产品

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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Sensitive detection of polymyxin B sulfate at the nanogram level using enhanced resonance scattering signals and decreased fluorescence signals with thioglycolic acid capped CdTe/CdS quantum dots as probe.
Shen Y, et al.
Sensors and Actuators B, Chemical, 188, 555-563 (2013)
Simultaneous determination of neomycin sulfate and polymyxin B sulfate by capillary electrophoresis with indirect UV detection.
Srisom P, et al.
Journal of Pharmaceutical and Biomedical Analysis, 43(3), 1013-1018 (2007)
Development of a liquid chromatographic method for ear drops containing neomycin sulphate, polymyxin B sulphate and dexamethasone sodium phosphate.
Pendela M, et al.
Journal of Pharmaceutical and Biomedical Analysis, 36(4), 751-757 (2004)

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