PHR1426

Spectinomycin Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : Spectinomycin
• Numéro CE : 244-554-3
• Numéro MDL: MFCD04041129
• Code UNSPSC : 41116107
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to Ph. Eur. Y0000597; traceable to USP 1618003
• Famille d'API: spectinomycin
• CofA (certificat d'analyse): current certificate can be downloaded
• Conditionnement: pkg of 500 mg
• Application(s): pharmaceutical (small molecule)
• Format: neat
• Température de stockage: 2-8°C

Description

Description générale

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.

Actions biochimiques/physiologiques

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.

Remarque sur l'analyse

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

Autres remarques

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.

Note de bas de page

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.

Informations sur la sécurité

• Pictogrammes: GHS07
• Mention d'avertissement: Warning
• Mentions de danger: H315,H319,H335
• Conseils de prudence: P261 - P264 - P271 - P280 - P302 + P352 - P305 + P351 + P338
• Classification des risques: Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3
• Organes cibles: Respiratory system
• Code de la classe de stockage: 11 - Combustible Solids
• Classe de danger pour l'eau (WGK): WGK 2
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable