Excipient Reference Materials
Los excipientes son ingredientes inactivos formulados junto con un Ingrediente Farmacéutico Activo (IFA) con fines como la estabilidad y la mejora terapéutica, incluyendo la facilitación de la absorción del fármaco o el aumento de la solubilidad del medicamento.
Estudios recientes han demostrado que los excipientes también pueden desempeñar un papel en la introducción de impurezas potencialmente peligrosas, como nitrosaminas de pequeña molécula, en productos farmacéuticos, lo que significa que deben ser evaluados exhaustivamente en cuanto a riesgos y monitoreados cuidadosamente durante todo el proceso de desarrollo del medicamento.
Como proveedor cualificado, conforme a GMP/GDP y con certificación EXCiPACT, ofrecemos más de 180 materiales de referencia de excipientes fabricados según los requisitos ISO/IEC 17025, y un número creciente acreditado según ISO 17034. Adecuados para su uso con métodos analíticos no compendiales, cada uno incluye un Certificado de Análisis (CoA) detallado que describe su caracterización.
Estudios recientes han demostrado que los excipientes también pueden desempeñar un papel en la introducción de impurezas potencialmente peligrosas, como nitrosaminas de pequeña molécula, en productos farmacéuticos, lo que significa que deben ser evaluados exhaustivamente en cuanto a riesgos y monitoreados cuidadosamente durante todo el proceso de desarrollo del medicamento.
Como proveedor cualificado, conforme a GMP/GDP y con certificación EXCiPACT, ofrecemos más de 180 materiales de referencia de excipientes fabricados según los requisitos ISO/IEC 17025, y un número creciente acreditado según ISO 17034. Adecuados para su uso con métodos analíticos no compendiales, cada uno incluye un Certificado de Análisis (CoA) detallado que describe su caracterización.
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Accredited within the boundaries of LGC’s fixed and flexible scope of UKAS accreditation. Further details can be found in the scheme description. ISO/IEC 17043 Specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes. Find out more.
The characterisation of this reference material was undertaken in accordance with the internationally recognised standard for the General Requirements for the Competence of Testing and Calibration Laboratories, ISO 17025 – required for the generation of valid results. Find out more.
{{ getAccreditationDisplayName(product) }} Produced in accordance with internationally recognised requirements for the development and production of reference standards and for the competence of reference standard manufacturers. Find out more.
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Accredited within the boundaries of LGC’s fixed and flexible scope of UKAS accreditation. Further details can be found in the scheme description. ISO/IEC 17043 Specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes. Find out more.
The characterisation of this reference material was undertaken in accordance with the internationally recognised standard for the General Requirements for the Competence of Testing and Calibration Laboratories, ISO 17025 – required for the generation of valid results. Find out more.
{{ getAccreditationDisplayName(product) }} Produced in accordance with internationally recognised requirements for the development and production of reference standards and for the competence of reference standard manufacturers. Find out more.
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Controlled product.
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Made to order.
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Short shelf life.
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This product will require custom synthesis.
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Accredited within the boundaries of LGC’s fixed and flexible scope of UKAS accreditation. Further details can be found in the scheme description. ISO/IEC 17043 Specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes. Find out more.
The characterisation of this reference material was undertaken in accordance with the internationally recognised standard for the General Requirements for the Competence of Testing and Calibration Laboratories, ISO 17025 – required for the generation of valid results. Find out more.
{{ getAccreditationDisplayName(product) }} Produced in accordance with internationally recognised requirements for the development and production of reference standards and for the competence of reference standard manufacturers. Find out more.
Restrictions may apply.
Additional documentation may be required such as permits or BSL certification.
Controlled product.
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Made to order.
Only produced when an order is placed.
Freight restricted.
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Short shelf life.
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This product will require custom synthesis.
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Accredited within the boundaries of LGC’s fixed and flexible scope of UKAS accreditation. Further details can be found in the scheme description. ISO/IEC 17043 Specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes. Find out more.
The characterisation of this reference material was undertaken in accordance with the internationally recognised standard for the General Requirements for the Competence of Testing and Calibration Laboratories, ISO 17025 – required for the generation of valid results. Find out more.
{{ getAccreditationDisplayName(product) }} Produced in accordance with internationally recognised requirements for the development and production of reference standards and for the competence of reference standard manufacturers. Find out more.
Restrictions may apply.
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Controlled product.
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Made to order.
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This product will require custom synthesis.
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Accredited within the boundaries of LGC’s fixed and flexible scope of UKAS accreditation. Further details can be found in the scheme description. ISO/IEC 17043 Specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes. Find out more.
The characterisation of this reference material was undertaken in accordance with the internationally recognised standard for the General Requirements for the Competence of Testing and Calibration Laboratories, ISO 17025 – required for the generation of valid results. Find out more.
{{ getAccreditationDisplayName(product) }} Produced in accordance with internationally recognised requirements for the development and production of reference standards and for the competence of reference standard manufacturers. Find out more.
Restrictions may apply.
Additional documentation may be required such as permits or BSL certification.
Controlled product.
We may require documentation to meet relevant regulations. Additional handling fees may apply and lead times may vary.
Made to order.
Only produced when an order is placed.
Freight restricted.
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Short shelf life.
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This product will require custom synthesis.
Please submit a quote request and our team will provide you with a price and lead time as soon as possible
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Accredited within the boundaries of LGC’s fixed and flexible scope of UKAS accreditation. Further details can be found in the scheme description. ISO/IEC 17043 Specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes. Find out more.
The characterisation of this reference material was undertaken in accordance with the internationally recognised standard for the General Requirements for the Competence of Testing and Calibration Laboratories, ISO 17025 – required for the generation of valid results. Find out more.
{{ getAccreditationDisplayName(product) }} Produced in accordance with internationally recognised requirements for the development and production of reference standards and for the competence of reference standard manufacturers. Find out more.
Restrictions may apply.
Additional documentation may be required such as permits or BSL certification.
Controlled product.
We may require documentation to meet relevant regulations. Additional handling fees may apply and lead times may vary.
Made to order.
Only produced when an order is placed.
Freight restricted.
{{ product.freightRestrictionTooltip }}
Short shelf life.
Check that the expiry date is fit for your purposes.
This product will require custom synthesis.
Please submit a quote request and our team will provide you with a price and lead time as soon as possible
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Accredited within the boundaries of LGC’s fixed and flexible scope of UKAS accreditation. Further details can be found in the scheme description. ISO/IEC 17043 Specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes. Find out more.
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