Reference Materials Management

Reference Materials Management
Product Description

To support you in bringing even safer medicines to the market, we go far beyond supplying you with the right reference standards. From impurity profiling and working standards outsourcing services, all the way to managing inventory and logistics of your reference standards, we’re fully equipped to provide you with a wide range of collaborative reference material management services. 
Mikromol’s strength in impurity profiling is built on an expert in-house team uniquely familiar with a broad range of APIs, degradation profiles and complex matrices. Whether you are dealing with an unknown impurity due to a change of formulation, method, dosage form or even profiling a new API, we can quickly identify your unknown peak(s) and propose likely mechanism(s) of formation to keep your project on track. Due to our company wide scientific resources and state of the art analytical instrumentation, we can offer additional follow up services, including analytical method recommendations, method validation and provision of reference standards for the unknown species. The flexibility offered by our global production sites means we can guarantee large volumes of API impurity working standards you need – combining ISO 17034 vial-to-vial homogeneity and validated peace of mind with the efficiency of outsourcing to a reliable, high-value technical partner. The fact that our API standards are of the highest quality – traceable, and immediately fit for purpose as working standards – reduces your risk, the need for analytical qualification, and time-consuming paperwork.

We understand that you may not always be able to store large quantities of stock on-site due to the capacity and resources that need to be allocated to handling this critical material, so let us handle it for you. Thanks to our +4,000m2 warehouse, we can receive, store, maintain, and deliver pharmaceutical standards. Our warehouse meets strict storage and stability specifications – including validity and purity trend analysis and maintaining chemicals at temperatures from -80°C to 21°C in different zones. When you call on your standard to support your project our globally experienced Supply Chain and Export departments effortlessly take charge of the distribution, management, and importation of our products in more than 130 countries.

Although moving scientific products across borders is becoming ever more complex, we continually stay up to date with new developments. You can rely on our global compliance specialists to assess every substance for air, land and sea transportation hazards and controls by CAS number or structure – in addition to ensuring adherence to national and international regulations. These include management of controlled substances, dangerous goods, military export lists and drug/chemical weapon precursors.


We regularly stress-test our distribution processes, making sure they work even in the most challenging countries because we know it is imperative for you to have a robust supply chain.

LGC Standards

  • GB
  • 2015
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Other

LGC Standards

  • GB
  • 2015
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Other

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LGC Standards resources (2)

  • News Why ISO 17034?

    As a provider of reference materials for a broad range of scientific industries, many of LGC Standards’ products are manufactured according to the International Organisation for Standardisation’s accreditation scheme for reference material providers, ISO 17034.

  • Brochure LGC Mikromol brochure

    Primary Pharmaceutical Reference Standards and Reference Material Services