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PHR1426

Supelco

Spectinomycin Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Spectinomycin

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About This Item

EC Number:
MDL number:
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to Ph. Eur. Y0000597
traceable to USP 1618003

API family

spectinomycin

CofA

current certificate can be downloaded

packaging

pkg of 500 mg

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

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General description

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to in-house working standards. Spectinomycin Hydrochloride is an aminocyclitol antibiotic, widely used in human medicine for the treatment of uncomplicated gonorrhea and also in veterinary medicine to treat bacterial respiratory and enteric infections. Its mode of action involves the inhibition of protein synthesis in the bacterial cell wall.

Application

Spectinomycin Hydrochloride may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using high-performance liquid chromatography with evaporative light scattering detection (HPLC−ELSD).
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

Mode of Action: Spectinomycin acts by inhibiting protein synthesis and elongation by binding to the bacterial 30S ribosomal subunit and interfering with peptidyl tRNA translocation.

Mode of Resistance: A mutation in rpsE, the gene for ribosomal protein S5, prevents the binding of spectinomycin. Resistance is also conferred by the aminoglycoside-3′-adenyltransferase gene (aadA).

Antimicrobial spectrum: Spectinomycin acts against gram-negative and gram-positive bacteria.

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 LRAC1683 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Hazard Classifications

Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3

Target Organs

Respiratory system

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

监管及禁止进口产品

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Certificates of Analysis (COA)

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Antibiotic Manual: A Guide to Commonly Used Antimicrobials (2011)
Analysis of spectinomycin by HPLC with evaporative light-scattering detection
Wang JM and Hu Q-C
Chromatographia, 63(5-6), 255-260 (2006)

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