IFF Pharma Solutions Launches Low Nitrite METHOCEL™ HPMC for Nitrosamine Mitigation
IFF Pharma Solutions has launched Low Nitrite METHOCEL™ HPMC, a specialized range of cellulose ethers designed to reduce nitrosamine formation risk in pharmaceutical dosages. The innovative product maintains nitrite levels at or below 200 parts per billion, verified through validated 2D ion chromatography with mass spectrometry testing for each batch.
The new product line offers the same reliability and performance as standard METHOCEL™ while addressing industry concerns about nitrosamine risk mitigation. Through enhanced process controls and analytical science, the company ensures minimal nitrite content, making it suitable for applications where low nitrite levels are crucial.
Every batch receives a nitrite test result on the certificate of analysis, demonstrating IFF's commitment to quality and safety standards in pharmaceutical manufacturing.
IFF Pharma Solutions ha lanciato Low Nitrite METHOCEL™ HPMC, una gamma specializzata di eteri di cellulosa progettata per ridurre il rischio di formazione di nitrosamine nelle dosi farmaceutiche. Il prodotto innovativo mantiene i livelli di nitrito a 200 parti per miliardo o inferiori, verificati tramite cromatografia ionica 2D validata con test di spettrometria di massa per ogni lotto.
La nuova linea di prodotti offre la stessa affidabilità e prestazioni del METHOCEL™ standard, affrontando al contempo le preoccupazioni del settore riguardo alla mitigazione del rischio di nitrosamine. Attraverso controlli di processo migliorati e scienza analitica, l'azienda garantisce un contenuto minimo di nitriti, rendendolo adatto per applicazioni in cui bassi livelli di nitrito sono cruciali.
Ogni lotto riceve un risultato del test di nitrito sul certificato di analisi, dimostrando l'impegno di IFF per gli standard di qualità e sicurezza nella produzione farmaceutica.
IFF Pharma Solutions ha lanzado Low Nitrite METHOCEL™ HPMC, una gama especializada de éteres de celulosa diseñados para reducir el riesgo de formación de nitrosaminas en las dosis farmacéuticas. El producto innovador mantiene los niveles de nitrito en 200 partes por mil millones o menos, verificado mediante cromatografía iónica 2D validada con pruebas de espectrometría de masas para cada lote.
La nueva línea de productos ofrece la misma fiabilidad y rendimiento que el METHOCEL™ estándar, abordando a su vez las preocupaciones de la industria sobre la mitigación del riesgo de nitrosaminas. A través de controles de proceso mejorados y ciencia analítica, la empresa asegura un contenido mínimo de nitrito, haciéndolo adecuado para aplicaciones donde los bajos niveles de nitrito son cruciales.
Cada lote recibe un resultado de prueba de nitrito en el certificado de análisis, demostrando el compromiso de IFF con los estándares de calidad y seguridad en la fabricación farmacéutica.
IFF Pharma Solutions는 Low Nitrite METHOCEL™ HPMC를 출시했습니다. 이는 제약 용량에서 니트로사민 형성 위험을 줄이기 위해 설계된 특수 셀룰로오스 에터의 전문화된 범위입니다. 이 혁신적인 제품은 각 배치에 대해 질량 분석을 통한 검증된 2D 이온 크로마토그래피로 확인된 바와 같이 니트리트 수준을 200ppb 이하로 유지합니다.
새로운 제품 라인은 표준 METHOCEL™과 동일한 신뢰성과 성능을 제공하면서도 니트로사민 위험 완화에 대한 산업의 우려를 해결합니다. 향상된 공정 제어 및 분석 과학을 통해 회사는 최소한의 니트리트 함량을 보장하여 낮은 니트리트 수준이 중요한 응용 분야에 적합하게 만듭니다.
모든 배치는 분석 인증서에 니트리트 테스트 결과를 받아 품질 및 안전 기준에 대한 IFF의 약속을 보여줍니다.
IFF Pharma Solutions a lancé Low Nitrite METHOCEL™ HPMC, une gamme spécialisée d'éthers de cellulose conçue pour réduire le risque de formation de nitrosamines dans les dosages pharmaceutiques. Le produit innovant maintient les niveaux de nitrite à 200 parties par milliard ou moins, vérifiés par chromatographie ionique 2D validée avec des tests de spectrométrie de masse pour chaque lot.
La nouvelle ligne de produits offre la même fiabilité et performance que le METHOCEL™ standard tout en répondant aux préoccupations de l'industrie concernant l'atténuation du risque de nitrosamines. Grâce à des contrôles de processus améliorés et à la science analytique, l'entreprise garantit un contenu minimal en nitrites, le rendant adapté aux applications où de faibles niveaux de nitrite sont cruciaux.
Chaque lot reçoit un résultat de test de nitrite sur le certificat d'analyse, démontrant l'engagement d'IFF envers les normes de qualité et de sécurité dans la fabrication pharmaceutique.
IFF Pharma Solutions hat Low Nitrite METHOCEL™ HPMC auf den Markt gebracht, eine spezialisierte Reihe von Cellulose-Ethern, die entwickelt wurde, um das Risiko der Bildung von Nitrosaminen in pharmazeutischen Dosierungen zu reduzieren. Das innovative Produkt hält die Nitritwerte bei oder unter 200 Teilen pro Milliarde, verifiziert durch validierte 2D-Ionenchromatographie mit Massenspektrometrie-Tests für jede Charge.
Die neue Produktlinie bietet die gleiche Zuverlässigkeit und Leistung wie das Standard-METHOCEL™, während sie gleichzeitig die Bedenken der Branche hinsichtlich der Risikominderung von Nitrosaminen anspricht. Durch verbesserte Prozesskontrollen und analytische Wissenschaft stellt das Unternehmen sicher, dass der Nitritgehalt minimal ist, was es für Anwendungen geeignet macht, bei denen niedrige Nitritwerte entscheidend sind.
Jede Charge erhält ein Testergebnis für Nitrit im Analysezertifikat, das das Engagement von IFF für Qualitäts- und Sicherheitsstandards in der pharmazeutischen Herstellung demonstriert.
- Addresses critical industry concern regarding nitrosamine risk mitigation
- Product maintains same reliability and performance as standard METHOCEL™
- Enhanced quality control with validated testing for each batch
- None.
Low Nitrite METHOCEL™ HPMC reduces the potential for nitrosamine formation and provides consistent results in finished dosages.
"METHOCEL HPMC is the polymer of choice for formulating both controlled release and immediate release pharmaceutical dosages," said Michael Baumann, global product manager, METHOCEL™, IFF Pharma Solutions. "Low Nitrite METHOCEL™ is designed to meet the highest standards of quality and safety. These specialized grades, which provide the same reliability and performance as standard METHOCEL™, help ensure minimal nitrite content, making them ideal for applications where low levels of nitrite are critical."
Effective in reducing nitrosamines in model formulations
Low Nitrite METHOCEL™ minimizes the potential of nitrosamine formation and helps ensure finished drug products comply with stringent safety regulations, enhancing the overall quality of our customers' drug products.
Designed to meet the highest standards of quality and safety
Using validated 2D ion chromatography with mass spectrometry, and with high selectivity and sensitivity, every batch receives a nitrite test result on the certificate of analysis. Each batch of Low Nitrite METHOCEL™ is tested to ensure nitrite levels are consistently at or below 200 parts per billion.
A dependable solution backed by polymer expertise
To ensure the best performance for our customers' drug products, Low Nitrite METHOCEL™ provides reliable and consistent results. This is supported by our polymer expertise and problem-solving mindset across the entire drug development pipeline.
For more information on Low Nitrite METHOCEL™, visit here.
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Emily Kaufman
Global Communications Specialist
+1 908.670.5691
emily.kaufman@iff.com
Source: International Flavors & Fragrances
FAQ
What are the nitrite level specifications for IFF's new Low Nitrite METHOCEL™ HPMC?
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What is the main benefit of IFF's Low Nitrite METHOCEL™ for pharmaceutical manufacturers?
How does Low Nitrite METHOCEL™ HPMC help pharmaceutical companies with regulatory compliance?
