Extractable and Leachable Reference Materials
Extractable and leachable impurities (E&L impurities) can occur when drug products interact with a wide and complex range of packaging, drug delivery, and manufacturing components. Compounds including plasticisers, antioxidants and PAHs can migrate into a dosage form via chemical transfer from sources such as containers, closure systems, process components or drug delivery systems.
Toxicological evaluation of any extractable and leachable impurity identified throughout the shelf life of a drug product is essential to ensure the dose does not raise safety concerns, cariogenic or otherwise.
Our high-quality range of extractable and leachable reference materials supports your drug safety testing, enabling you to have confidence in the integrity of both your results and products. They can also help ensure your laboratory's compliance with key E&L guidance, such as USP 661.1.
Toxicological evaluation of any extractable and leachable impurity identified throughout the shelf life of a drug product is essential to ensure the dose does not raise safety concerns, cariogenic or otherwise.
Our high-quality range of extractable and leachable reference materials supports your drug safety testing, enabling you to have confidence in the integrity of both your results and products. They can also help ensure your laboratory's compliance with key E&L guidance, such as USP 661.1.
48-hour USA dispatch time
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- Related Impurities:
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{{ getAccreditationDisplayName(product) }} 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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{{ getAccreditationDisplayName(product) }} 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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You must comply with your country’s regulations.
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{{ getAccreditationDisplayName(product) }} 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
- Product Code: {{ product.sourcePart ? product.sourcePart : product.code }}
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- Synonyms: {{ getMatchedSynonym(product.synonymsList) }}
{{ getAccreditationDisplayName(product) }} 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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{{ getAccreditationDisplayName(product) }} 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
- Product Code: {{ product.sourcePart ? product.sourcePart : product.code }}
- CAS Number: {{product.listCASNumber | tostring }}
- Product Line: Brand: {{ product.brand.name }} {{ product.manufacturer }}
- Product type: {{product.productType.join(', ')}}
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- Purity: {{ product.purity }}
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- Synonyms: {{ getMatchedSynonym(product.synonymsList) }}
{{ getAccreditationDisplayName(product) }} 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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