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PHR1716

Supelco

Capreomycin Sulfate

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Capreomycin sulfate salt
CAS Number:
1405-37-4
EC Number:
215-776-8
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to BP 59
traceable to USP 1091006

API family

capreomycin

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/C25H44N14O8.H2O4S/c26-4-1-2-11(27)6-17(41)32-8-14-20(43)35-15(9-34-25(30)47)21(44)39-18(13-3-5-31-24(29)38-13)23(46)33-7-12(28)19(42)37-16(10-40)22(45)36-14;1-5(2,3)4/h9,11-14,16,18,40H,1-8,10,26-28H2,(H,32,41)(H,33,46)(H,35,43)(H,36,45)(H,37,42)(H,39,44)(H3,29,31,38)(H3,30,34,47);(H2,1,2,3,4)/b15-9-;

InChI key

AJQVUIHGEOLMDY-SOCRLDLMSA-N

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General description

Capreomycin sulfate is a disulfate salt of the polypeptide antibiotic drug, capreomycin, that is administered either parenterally or in the form of aerosols. It is generally used against multidrug-resistant tuberculosis (MDR-TB).
Pharmaceutical secondary standard for application in quality control. Provides pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

Capreomycin sulfate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography techniques.
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 LRAC3042 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Health hazardExclamation mark
GHS08,GHS07

Signal Word

Danger

Hazard Statements

H302 + H312 + H332,H360

Hazard Classifications

Acute Tox. 4 Dermal - Acute Tox. 4 Inhalation - Acute Tox. 4 Oral - Repr. 1B

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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Development and validation of a liquid chromatographic method for the analysis of capreomycin sulfate and its related substances
Mallampati S, et al.
Journal of Chromatography A, 1216(12), 2449-2455 (2009)
Isolation and identification of four major impurities in capreomycin sulfate
Liu G, et al.
Journal of Chromatography A, 1571(12), 155-164 (2018)
Inhaled large porous particles of capreomycin for treatment of tuberculosis in a guinea pig model
Garcia-Contreras L, et al.
Antimicrobial Agents and Chemotherapy, 51(8), 2830-2836 (2007)

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