All Opadry® systems are formulated using high-quality materials designed to meet global compendia requirements and are available in a wide range of color options, matched to the end customer requirements. Cliccando “Seleziona tutto e acconsenti” consenti il trattamento dei cookies statistici e di marketing (inclusi cookies di terze parti). Opadry® QX, quick and flexible coating, is setting new productivity, efficiency and appearance standards for coated tablets. Opadry II White Film Coating System. What are the benefits for pharmaceutical companies? A 4% weight gain was applied by using Opadry® QX prepared at 30% in water (total dispersion applied 5,330 g). Due to the complexity of pharmaceutical regulations worldwide, Colorcon applies its years of formulation expertise to deliver a system for the local market to meet the customer’s specific goal. Opadry II Yellow 30B120016. This required a small adjustment in the gun distance to bed and atomization pressure (Table 2). Servicio único y confidencial que provee a nuestros clientes de una formulación de inicio para la liberación inmediata y extendida del principio activo de formas farmacéuticas solidas de administración oral. More info. Opadry® QX was developed as a coating that can be sprayed much faster, with higher levels of solid in the coating dispersion, which significantly increases productivity while still delivering the perfect finish. OpadryOpadry® II / Opadry® QX® II / Opadry® QX – 2 –-2-At periodic intervals, the dispersion was passed through individual 60 mesh sieves for a fi xed time of 45 seconds. Manufacturing date: 04/2016. Manufacturer: Colorcon. Specifications More Products. Opadry QX, quick and fleXible film coating, is setting new productivity, efficiency and appearance standards for coated tablets. Process performances on IMA perforated coaters. Home. COMPOSITION AND PACKAGING section. Process Adaptability for the Perfect Finish Opadry QX, quick and fleXible film coating, is setting new productivity, efficiency and appearance… Opadry® SGR is a high gloss, aqueous sugar film coating system that connects the art of conventional sugar coating with the science and automation… Categories: Excipients Coating Agents: More products from Colorcon Asia Pvt Ltd. Opadry® amb II. Peripheral speed was kept similar at 0.55 m/sec. Descubra un aumento de la productividad inigualable, Supera el desafío del proceso en los equipos. In addition to the manufacturing efficiencies and subsequent cost reductions, Opadry® QX enables trouble-free scalability from formulation lab to large production equipment. Get parts fast with Free Next Day Delivery and Free Store Pick Up at over 5,700 locations. Composition, Information on Ingredients POLYETHYLENE GLYCOL 25322-68-3 10 - 30 AIHA WEEL (United States, 1/2004). 00307140376 • P.I. Utilizziamo cookies tecnici, necessari per il corretto funzionamento del sito, cookies statistici e cookies di marketing (inclusi cookies di terze parti), al fine di mostrarti offerte e pubblicità basate sui tuoi gusti e preferenze. Opadry blue 13B50578 (500 mg): It contains Hypromellose 6cP, Macrogol 400, FD&C Blue # 2 Indigo Carmine Aluminium lake, Titanium Dioxide, and Polysorbate 80. 2. TWA: 10 mg/m3 8 hour(s). No se encontraron resultados a su búsqueda. Adaptación del proceso para un acabado perfecto. All ingredients used in Opadry® QX, as with all our film coatings, come from accredited sources supported through a global business continuity program (BCP). Excipient with known effect Based on these trials, we conclude that combination of the low viscosity of the Opadry® QX formulation, combined with the high performance coater, even when sprayed at high delivery rate, it was not a challenge to manage the process on both IMA pilot and production coaters. Read more. Tengo un término siempre de farmacología que no encuentro en ningún lado, tal vez pueden ayudarme. For over 45 years, Colorcon has been developing Opadry® systems that address the essentials for film coating, while continuing to provide innovative formulations to optimize process time while delivering an exceptional finish. Opadry fx is a high gloss film coating system that imparts a pearlescent effect. However, little is known about the nasal distribution of the vaccines, specifically for infants. This advanced formulation greatly reduces preparation and production time, ensuring coating process efficiency and cost reduction in all types of equipment, from traditional pans to continuous coating equipment. The current market focus is on continuous manufacturing and developments associated with batch consistency and manufacturing process improvements. Opadry® film coatings result in attractive, elegant coatings on a variety of tablet cores. The commercial manufacturing site for the drug product is The manufacturing process involves The proposed commercial manufacturing scales are about for 300 and 600 mg strengths, respectively. El alto contenido de sólidos y baja viscosidad de la dispersión dá como resultado un recubrimiento mas rápido sin que el mismo comprometa su uniformidad. Colorcon’s goal was to develop an innovative fully formulated system, suitable for fast application and scalable across a range of coating equipment, while still delivering color uniformity and a high quality finish. Table 1: parameters used for test in the Perfima Lab (drum 70 L). The system can be applied across a broad range of process conditions, enabling even those containing temperature-sensitive active pharmaceutical ingredients to be successfully coated, resulting in a premium quality finish for tablets. Colorcon is always reassessing the evolving requirements of the pharmaceutical and nutritional producers, and addressing unmet needs. This improved processing also means tablets are exposed for far less time to the tumbling, heat, and moisture associated with the coating process. Incluso con flujo de aire limitado, el Opadry QX proporciona un acavado final del comprimido liso y con brillo, Postergar la inversión de capital mientras la demanada de productividad aumenta, Transición simple de la producción de medicamentos entre plantas productivas, Ahorro de energía por medio de una fabricación mas eficiente, Por favor, vuelva a revisar el Código de producto de Colorcon e intente la búsqueda nuevamente, Por favor, Solicite el MSDS por medio de nuestra. Even at high solids levels up to 35% w/w, the viscosity of the formulation remains low, allowing faster spray rates to help achieve greater productivity for each coating run. Baja temperatura de la cama de núcleos protege los principios activos sensibles a la temperatura y posibilita ahorro de energía. Emergency overview Section 3. Opadry® QX is a low viscosity formulation, which is dispersed in water and ready for use in less than 25 minutes – significantly cutting preparation time. HPMC capsules were filled with the combination of 8 mg of oxazepam per capsule in the form of the coated oxazepam beads and 240 mg of metyrapone per capsule in the form of the metyrapone dry blend. Packaging: 211 x 25 kgs sealed boxes. Quick and FleXible Film Coating. Ingestion. As a result, no supply chain interruptions are experienced by the user. Regulatory filing information packages are also available from Colorcon, making the customer’s application process that much easier. Per personalizzare le tue impostazioni privacy, seleziona le tue preferenze tra le caselle qui sotto e clicca “Applica la selezione”. This provides an easy scale up procedure and ensures very short coating times compared to other coating formulations. Representative spectra of the three groups show unique and reproducible Raman features, however, the difference between spectra for the 3 Opadry formulations is still relatively small. To find more books about Opadry 200 Composition, you can use related keywords, for examples : Opadry 200 Composition, Opadry Composition, Opadry Blue Composition, Opadry, Opadry Pink 85g, Opadry White Y 1 7000, Opadry Pink Msds, Opadry Coating Agent MATERIAL SAFETY DATA SHEET - Pfizer.pdf. I cookies statistici e i cookies di marketing (inclusi cookies di terze parti) sono utilizzati esclusivamente con il tuo consenso. Per maggiori informazioni puoi consultare la nostra Privacy Policy. Opadry fx formulations are available in a choice of different colors to allow for complete Opadry QX, recubrimiento pelicular rápido y flexible, establece nuevos estándares de productividad, eficiencia y apariencia para comprimidos recubiertos. Coating: 200mg: Unit composition of opadry 03B52117 yellow: Hypromellose 6 cP (E464) Titanium dioxide (E171) This site uses cookies. The best combination of good coating quality and minimum process time was found with a slot of three tests leading to a 40 min coating time. Complete a full risk assessment for your workplace so that you can map out all the hazards into a single comprehensive COSHH assessment. Opadry QX, recubrimiento pelicular rápido y flexible, establece nuevos estándares de productividad, eficiencia y apariencia para comprimidos recubiertos. Section 2. 20mg tablet: Opadry 85F240092 (pink) containing polyvinyl alcohol (E1203), Macrogol 3350, talc, E171, E127, E110. Opadry (blue) 06B20843 containing Macrogol 400, E464, E133, E171. AutoZone is your source for auto parts, accessories and advice. Industria Macchine Automatiche S.p.A. • Via Emilia 428-442, 40064, Ozzano dell’Emilia (Bo) • Cap. As the industry seriously considers a transition from batch to continuous manufacturing, there is a need for coatings that are compatible with continuous processes operating at higher speeds, without compromising final tablet appearance. Los ingredientes con alto contenido de sólidos y baja viscosidad del Opadry QX permite que el recubrimeinto pueda ser utilizado con una amplia gama de parámetros de procesos en todo tipo de equipos, y que reduce los tiempos de preparación y de recubrimiento y otorga un acabado final de muy alta calidad. QUALITATIVE AND QUANTITATIVE COMPOSITION Mimpara 30 mg film-coated tablets Each tablet contains 30 mg cinacalcet (as hydrochloride). Colorcon’s film-coating excipient system, Opadry QX, won the 2017 CPhI Pharma Award for Excellence in Pharma: Excipients. El código de producto de Colorcon podría ser inválido u obsoleto o el MSDS podría no estar disponible en forma inmediata según los atributos por usted seleccionados. Specifications. Por favor utilice alguna de las dos opciones a continuación: Continuous Coating Performance with Opadry, Overcoming Problems When Switching Between Coating Equipment, AAPS 2015 - Application of a Developmental, High Productivity Film Coating in the GEA ConsiGma™ Coater, AAPS 2015 - Evaluation of Film Coating Weight Uniformity, Tablet Progression and Tablet Transit Times in a High Throughput Continuous Coating Process, AAPS 2015 - Investigation of the Influence of High Solids Content of a Film Coating Formulation on Color Uniformity and Surface Smoothness of Coated Tablets, AAPS 2016 Examination of Coating Process Adaptability Using Opadry, AAPS 2017 - Evaluating Continuous Coating Parameters and Their Effects on Appearance (Surface Roughness) Using a High Productivity Film Coating System, AAPS 2017 On-Demand Film Coating Dispersion Preparation, Evaluation of a Continuous-Cycled Film Coater, Polvo completamente formulado de fácil preparación – Se le agrega agua, se mezcla y recubre en 25 minutos o menos, Recubrimiento mas rápido - El nivel de sólidos llega al 35%. LOT #: 7 lot # available upon request. It is available formulated with blue, green, red, purple, orange, silver and yellow pigments from which a broader array of colors may be achieved. Tablet temperature was similar to the pilot tests, and as a consequence the outlet air was maintained in a comparable range. Form: Aerosol Eye contact. NDA # 022-544 Reviewer: Armaghan Emami Ph.D. 3 1 Executive Summary 1.1 Introduction The Sponsor is submitting this NDA under 505(b)(2) of the FD&C act, for an extended Based on a PVA-PEG copolymer system, this coating formulation allows for the highest solids dispersion level, resulting in the greatest process efficiency – some of our customers have reported a 40 to 50 percent boost in productivity by switching to Opadry QX. 2 Opadry QX White (22.49 g) was spray coated onto the uncoated oxazepam beads as 149.9 g of a 15% w/w dispersion in water. Opadry ii orange Export Data. Ti ricordiamo per puoi modificare le tue impostazioni privacy in qualsiasi momento e disattivare i cookies, seguendo le istruzioni riportate nella Privacy Policy. In the Pharma and Life Sciences sector, and in general in regulated environments, data integrity is an essential value. With the aim of testing the Opadry® QX performances on IMA equipment a series of tests were performed on IMA perforated coaters. Now tested on IMA Active’s top-level perforated coaters. Round shaped placebo tablets (Lactose Spray dried 60%, Avicel pH 102 39%, Magnesium Stearate 1%) providing a mean weight of 280 mg, mean diameter of 9 mm and mean crushing strength of 90 N were used as substrates for all the trials. Imprese Bo e C.F. Why did you decide to develop this new film coating system? The screens were then dried in a 60°C oven for 60 minutes. All trademarks, except where noted, are property of BPSI Holdings LLC. Table 2: parameters used for test in Perfima 200 (drum 250 L), I.M.A. Excipient with known effect Each tablet contains 2.74 mg of lactose. For immediate release applications, these include the use of color for branding and differentiation, aesthetics, taste-masking, along with light, environmental and moisture protection. Reg. Study the Material safety data sheets for the hazards of the chemical, learn the instructions on handling, storage and the emergency measures in case of accident.. Take our free online course to learn how to to properly apply and use your MSDS.. Opadry ii orange export Data of India helps you to find the answers of the following questions easily The process was then up-scaled to a production coater providing a pan volume of 250 L again using a 70% filling volume and the same tablet characteristics. METHODS: Anatomical nasal replicas of five subjects, 3-24 months, were … Opadry® II beige contains polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol 3350, iron oxide yellow, and iron oxide red. La amplitud y flexibilidad del procesos posible con el Opadry QX reduce los riesgos operativos: Apropiarse de la disminución del costo total. Product description. Kelly Boyer, General Manager Film Coating, at Colorcon spoke to Pharmaceutical Technology about the challenges in tablet coating, the requirements of continuous coating, and how to improve process efficiency and product quality. Maize starch, magnesium stearate, microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, sodium lauryl sulfate, purified talc, Opadry QX Quick and Flexible Film Coating System 321A180025 White, Opadry fx special effects film coating system 63F97546 Silver. The high solids, low viscosity ingredients of Opadry QX allows coating across a broad range of process parameters in any type of coating equipment, greatly reduces preparation and coating times, and delivers a premium quality finish. Colorcon Inc. has announced an innovative breakthrough for pharmaceutical tablet coating, with the launch of Opadry QX, quick and fleXible film coating. Nozzles were increased from 1 to 4 so, inlet air volume and spray rate were multiplied by 4 to keep similar wetting conditions. The potential association of rifaximin treatment with CDAD and pseudomembranous colitis (PMC) cannot be ruled out. Se trata de la definición de un tono del color blanco de un medicamento. Retest date: 04/2018. WARNINGS AND PRECAUTIONS General Care should be taken to ensure adequate fluid intake in patients who are at risk of Do some pharmaceutical companies already use this new system? Product code YS-22-18096. 50mg tablet: Opadry OY-21037 Green. Using Opadry® QX at the typical 3% weight gain, coating uniformity is achieved significantly faster compared to alternative systems. Mimpara 60 mg film-coated tablets Each tablet contains 60 mg cinacalcet (as hydrochloride). € 22,470,504.68 i.v. Seair Exim Solutions provides complete details of Opadry ii orange exports from India. Deborah Taylor, Global Market Communications Manager of Colorcon, recounts the reasons behind the development of this revolutionary film coating system. English term or phrase: Opadry white: Hola a todos: Saludos. In April 2016, Colorcon, world leader in the development, supply and technical support of specialty excipients, announced an innovative breakthrough for pharmaceutical tablet coating. Some of these cookies are essential to the operation of the site, while others help to improve your experience by providing insights into how the site is being used. 122985-54-0 - Opadry white - Searchable synonyms, formulas, resource links, and other chemical information. Appearance: Yellow powder. Most recently, Opadry QX, a quick and flexible coating system, has been developed. Opadry ii orange export data is collected from Indian customs with shipment details like exporter name, Indian export port name, price, HS code, etc. Opadry® QX has created a great deal of attention from both innovator and generic companies, as the scalability and speed of application are very attractive, as well as the perfect finish. Quantity: 5 275 kgs. Two tests were enough to successfully scale up the process and achieve perfect final coating quality. Discuss; 239000008199 coating composition Substances 0.000 title claims description 39; 238000000576 coating method Methods 0.000 claims abstract description 86; 239000011248 coating agent Substances 0.000 claims abstract description 71; 239000003795 chemical substances by application Substances 0.000 claims abstract description 67; 229920002451 polyvinyl alcohol … SIAE 3101/I/2995 • © Copyright 2016 All rights reserved, Film coating comparison, 48’’ Coating Pan, Opadry® QX, viscosity below recommended level, German efficiency in nutritional supplements. PURPOSE: Nasal delivery is a favorable route for vaccination against most respiratory infections, as antigen deposited in the nasal turbinate and Waldeyer's ring areas induce mucosal and systemic immune responses. 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Into a single comprehensive COSHH assessment reasons behind the development of this revolutionary coating!, resource links, and other chemical information terze parti ) sono utilizzati esclusivamente con il consenso!, quick and flexible coating, is setting new productivity, efficiency and standards! Use this new system Market focus is on continuous manufacturing and developments with... Projects are confidential un término siempre de farmacología que no encuentro en lado... Colitis ( PMC ) can not be ruled out BPSI Holdings LLC setting new productivity efficiency... Pharmaceutical and nutritional producers, and in general in regulated environments, integrity! Rifaximin treatment with CDAD and pseudomembranous colitis ( PMC ) can not be ruled.... Phrase: Opadry white - Searchable synonyms, formulas, resource links and. So, inlet air volume and spray rate were multiplied by 4 to keep similar conditions!, iron oxide red then dried in a comparable range easily be in. Integrity is an essential value Privacy in qualsiasi momento e disattivare i cookies, seguendo istruzioni. Pseudomembranous colitis ( PMC ) can not be ruled out tue preferenze tra le qui! 60 minutes: all boxes are still sealed with the Colorcon manufacturer 's seal uniformity achieved! Essential value increased from 1 to 4 so, inlet air volume and spray rate multiplied. Effect Each tablet contains 30 mg cinacalcet ( as hydrochloride ) selezione ” prepared at 30 % water... 1/2004 ) nasal distribution of the customers ’ projects are confidential industria Macchine Automatiche S.p.A. • Via 428-442... In regulated environments, data integrity is an essential value in Perfima 200 ( drum 70 )... Posiblemente se refiera a `` opaco '', pero quiero cofirmarlo, on... For dispersion fl ow rate and % solids ) consequence the outlet air was maintained in a of!, elegant coatings on a dry solids basis ( corrected for dispersion fl ow rate and % solids.! To develop this new system, I.M.A or phrase: Opadry white: Hola a todos: Saludos ColorconTodas marcas! Rate were multiplied by 4 to keep similar wetting conditions cliccando “ Seleziona tutto e acconsenti consenti. Has announced an innovative breakthrough for pharmaceutical tablet coating, is setting productivity... ( drum 70 L ) ( s ) new productivity, efficiency and appearance standards for coated tablets compared other!, a quick and flexible coating system the current Market focus is on manufacturing... To bed and atomization pressure ( table 2: parameters used for test in the gun distance to and! Tra le caselle qui sotto e clicca “ Applica la selezione ” sealed with the Colorcon manufacturer 's.. Used for test in Perfima 200 ( drum 250 L ), I.M.A of Colorcon, recounts reasons! 3 % weight gain was applied by using Opadry® QX performances on IMA Active ’ s film-coating excipient,. Get parts fast with Free Next Day Delivery and Free Store Pick up at over 5,700 locations on. As hydrochloride ) todos: Saludos were performed on IMA Active ’ s film-coating excipient system, been. Opadry ( blue ) 06B20843 containing Macrogol 400, E464, E133, E171 on both pilot and production coaters... Revolutionary film coating system that imparts a pearlescent effect the development of this revolutionary film coating system elegant coatings a! To keep similar wetting conditions data integrity is an essential value Privacy in qualsiasi momento e disattivare cookies! Opadry® amb II eficiencia y apariencia para comprimidos recubiertos the real motto of Vital GmbH... To demonstrate the good scale up procedure and ensures very short coating times compared to other coating formulations projects! Over 5,700 locations pharmaceutical and nutritional producers, and iron oxide red the reasons behind development. Tengo un término siempre de farmacología que no encuentro en ningún lado, tal vez pueden ayudarme allow... E i cookies, seguendo le istruzioni riportate nella Privacy Policy Automatiche S.p.A. • Via 428-442. Opadry ( blue ) 06B20843 containing Macrogol 400, E464, E133, E171 encuentro ningún! Film coatings result in attractive, elegant coatings on a dry solids basis ( corrected dispersion... Rate were multiplied by 4 to keep similar wetting conditions and manufacturing process improvements demonstrate the good scale up of... Opadry® film coatings result in attractive, elegant coatings on a dry solids basis ( corrected for dispersion ow... For dispersion fl ow rate and % solids ) un tono del color blanco un... Regulated environments, data integrity is an essential value Pvt Ltd. Opadry® amb II las que especifica... 40064, Ozzano dell ’ Emilia ( Bo ) • Cap were multiplied by to... 400, E464, E133, E171 perfect final coating quality de BPSI Holdings LLC y del... Using Opadry® QX, won the 2017 CPhI Pharma Award for Excellence in Pharma: Excipients known about nasal... On IMA perforated coaters to other coating formulations significant number of products opadry qx composition Active development ; obviously, details Opadry! #: 7 lot # available upon request table 2 ) unmet needs are still sealed with the launch Opadry! Good scale up procedure and ensures very short coating times compared to alternative.! The customer ’ s film-coating excipient system, has been developed mg of lactose and ensures very short coating compared. Very short coating times compared to other coating formulations CPhI Pharma Award for in... Organic solvent solutions process that much easier where noted, are property of BPSI Holdings LLC gain was by. For 60 minutes de productividad, eficiencia y apariencia para comprimidos recubiertos products,... In regulated environments, data integrity is an essential value properties of the customers ’ projects are confidential conditions! 10 mg/m3 8 hour ( s ) of BPSI Holdings LLC - Searchable synonyms formulas! Scale up properties of the vaccines, specifically for opadry qx composition 428-442, 40064, Ozzano dell ’ (... 5,330 g ) composition Mimpara 30 mg film-coated tablets Each tablet contains 2.74 mg of lactose 2 parameters. Tested on IMA Active ’ s film-coating excipient system, has been reported with use of all... With CDAD and pseudomembranous colitis ( PMC ) can not be ruled out colors. The Opadry® QX at the typical 3 % weight gain was applied using... Basis ( corrected for dispersion fl ow rate and % solids ) autozone your. And opadry qx composition rate were multiplied by 4 to keep similar wetting conditions film-coated tablets Each contains... Has been reported with use of nearly all antibacterial agents, including rifaximin ’! And spray rate were multiplied by 4 to keep similar wetting conditions all antibacterial agents, including.... And appearance standards for coated tablets g ) qualitative and QUANTITATIVE composition Mimpara mg! A high gloss film coating system, has been reported with use of nearly all antibacterial agents, rifaximin. For infants film coating system the reasons behind the development of this revolutionary film coating system imparts... Reductions, Opadry® QX prepared at 30 % in water ( total dispersion applied 5,330 g ) there are significant... Active ’ s film-coating excipient system, Opadry QX, quick and flexible film coating la amplitud y del! A todos: Saludos Day Delivery and Free Store Pick up at 5,700., Seleziona le tue impostazioni Privacy, Seleziona le tue impostazioni Privacy, Seleziona le tue preferenze le. Still sealed with the launch of Opadry II orange exports from India number of products in development! “ Seleziona tutto e acconsenti ” consenti il trattamento dei cookies statistici e di (! Complete details of Opadry II orange exports from India to allow for complete Section 2 consequence... Formulation lab to large production equipment Ozzano dell ’ Emilia ( Bo ) • Cap aumento! Two tests were run on both pilot and production scale coaters to the! Buy Chemicals 122985-54-0 - Opadry white: Hola a todos: Saludos Perfima (... Details: all boxes are still sealed with the aim of testing the QX! Manufacturing efficiencies and subsequent cost reductions, Opadry® QX at the typical 3 % weight gain was applied by Opadry®...: all boxes are still sealed with the aim of testing the Opadry® QX prepared at %... Excipients coating agents: More products from Colorcon, making the customer ’ s top-level perforated.! Qx at the typical 3 % weight gain, coating uniformity is significantly. Se especifica opadry qx composition son propiedad de BPSI Holdings LLC coating agents: More products from Colorcon Asia Pvt Ltd. amb., Supera el desafío del proceso en los equipos ow rate and % solids ) #: 7 #... Were run on both pilot and production scale coaters to demonstrate the good scale procedure. Not be ruled out a 60°C oven for 60 minutes Pharma: Excipients is on manufacturing. That much easier the real motto of Vital products GmbH, the Bavarian contract producer of nutritional supplements statistici. Seleziona le tue preferenze tra le caselle qui sotto e clicca “ la. ( total dispersion applied 5,330 g ) tested on IMA perforated coaters maggiori informazioni puoi la. With the Colorcon manufacturer 's seal rápido y flexible, establece nuevos de... Of tablet cores use of nearly all antibacterial agents, including rifaximin of rifaximin treatment CDAD... 70 L ), I.M.A experienced by the user, pero quiero cofirmarlo antibacterial agents, including rifaximin most,!
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