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LGC

Quality Assurance and Research Tools for Pharmaceutical Developers

LGC supplies a range of reference materials and proficiency testing schemes for the development of pharmaceutical products.

Website
Address
Queens Road,
Teddington,
Middlesex,
TW11 0LY,
United Kingdom
Phone

LGC is a global manufacturer and provider of reference standards. We have a long history in measurement science and producing reference materials for a wide range of applications.

Our facilities

Through a sustained programme of investment over more than a decade, LGC now has an unparalleled breadth of reference standards manufacturing capabilities.

We have manufacturing facilities around the world – in Luckenwalde, Germany; Augsburg, Germany; Manchester, New Hampshire and Charleston, South Carolina – all of which have been operating for over 20 years and are accredited to ISO 9001, ISO/IEC 17025 and ISO 17034. We have also recently opened our first reference materials manufacturing site in Nanjing, China.

Our manufacturing

LGC’s manufacturing capabilities support a large portfolio of catalogue reference standards for a wide variety of application areas, including products sold under the Dr. Ehrenstorfer™, Mikromol™, VHG™and ARMI™ brands. Alongside these catalogue ranges, we also provide a full suite of custom reference standards manufacturing services, including complete outsourcing solutions from sourcing/synthesis of materials through characterisation, certification, packaging and distribution.

Mikromol supplies quality assurance and research tools for pharmaceutical companies, including reference materials and proficiency testing schemes.
Our experience in outsourcing and customs complements our range of analytical products and services.
We offer robust internal quality control at all stages of the analytical process.
All our services follow good manufacturing practice (GMP) and good documentation practice (GDP) principles.
Our excipient standards are suitable for calibration, assay development, or as working standards.
Mikromol's API reference standards have a tight target measurement uncertainty (MU) of 0.5%.
We have a portfolio of more than 4,000 impurity reference standards.
Our expert in-house team has experience with a broad range of APIs, degradation profiles, and complex matrices.

Mikromol – Together, beyond the standard

Pharmaceutical reference standards and reference material services

LGC goes beyond the standard to ensure the reliability of your analysis regardless of the method used. We offer robust internal quality control, including strict release criteria and continuous quality monitoring throughout the lifecycle of standard, ISO-accredited methodology, as well as homogeneity assessments.

We provide comprehensive Certificates of  Analysis (COAs) to ensure the transparency and availability of results, from 100% mass balance to volatile contents, original spectra, chromatograms, and method details. Our teams use orthogonal methods to establish identities and assays, allowing quantitative use of the standard  In any method being used in your laboratory.

All our services adhere to Good Manufacturing Practice (GMP) and Good  Distribution Practice (GDP) principles, as shown by our EXCiPACT® certification. We also follow stringent packaging and labelling protocols to ensure regulatory conformity.

Active Pharmaceutical Ingredient (API) primary reference standards

Mikromol’s reference standards for active pharmaceutical ingredients (APIs) are primary quantitative standards – most of them are accredited to ISO 17034 standards and designed to ensure the highest analytical accuracy and reliability. Because their intended use is for potency assessments, calibrations, drug substance and drug product release testing, they have a tight target measurement uncertainty (MU) of 0.5%.

For more information, please click here.

Excipient and Concomitant component standards

Designed to deliver the highest accuracy and reliability, Mikromol’s excipient standards are primary quantitative standards that are suitable for calibration, assay development, or as working standards. Most of the excipient products in our range are ISO 17034-accredited and all are supplied with detailed COAs featuring identity, purity, and assay data.

For more information, please click here.

Impurity reference standards

The Mikromol portfolio of more than 4,000 impurity reference standards is of the highest quality and designed to help detect degradation products in APIs and excipients, thereby ensuring they meet the limits and threshold values set by legislators and regulatory bodies.

For more information, please click here.

Custom reference standards

Mikromol understands that our clients are constantly discovering new actives and impurities of interest, so each year, our dedicated, highly-qualified customs team produces hundreds of new materials to fulfil the individual impurity profiling and API qualification needs of customers all around the world.

For more information, please click here.

Reference materials management

To support clients in bringing even safer medicines to the market, Mikromol goes far beyond supplying the right reference standards. From impurity profiling and working standards outsourcing services, to managing inventories and logistics of reference standards, we are fully equipped to provide a wide range of collaborative reference material management services.

For more information, please click here.

About Mikromol

Mikromol was founded following the fall of the Berlin Wall with the aim to provide access to tools that would enable unified quality control systems in drug release, which the East German market had lacked.

Since our foundation, the collaborative spirit that defined our start has continued through our relationships with drug manufacturers and method developers to grow our understanding of clients’ needs. We aim to offer one of the pharmaceutical industry’s broadest portfolios of reference standards and reference material services, helping companies create ever better, safer medicines.

Excipient and Concomitant Component Standards

Designed to deliver the highest accuracy and reliability, Mikromol’s excipient standards are primary quantitative standards that are suitable for calibration, assay development, or as working standards.

Impurity Reference Standards

The Mikromol portfolio of more than 4,000 impurity reference standards is of the highest quality and designed to help detect degradation products in active pharmaceutical ingredients (APIs) and excipients, thereby ensuring they meet the limits and threshold values set by legislators and regulatory bodies.

Custom Reference Standards

Mikromol understands that our clients are constantly discovering new actives and impurities of interest, so each year, our dedicated, highly-qualified customs team produces hundreds of new materials to fulfil the individual impurity profiling and API qualification needs of customers all around the world.

Reference Materials Management

To support clients in bringing even safer medicines to the market, Mikromol goes far beyond supplying the right reference standards. From impurity profiling and working standards outsourcing services, to managing inventories and logistics of reference standards, we are fully equipped to provide a wide range of collaborative reference material management services.

LGC Standards

Queens Road
Teddington
Middlesex
TW11 0LY
United Kingdom

Brazil

LGC Standards Brasil Exp e Imp Ltda
Av Salmão, 663 – Sala 62, Jd Aquarius
São José dos Campos, SP
12246-260
Brazil

Bulgaria

LGC Standards Sp. Z.o.o.
Bul. 'GM Dimitrov' 52А
Office 102
1797 Sofia
Bulgaria

China

LGC Science (Shanghai)
Room 901-903, Garden Square
No. 968, West Beijing Road
Jing'an District
200041
Shanghai
China

China (Proficiency Testing)

LGC Science (Shanghai)
Room 901-903, Garden Square
No. 968, West Beijing Road
Jing'an District
200041
Shanghai
China

France

LGC Standards SARL
6, Rue Alfred Kastler
B.P. 83076
Molsheim
67123
France

Germany

LGC Standards GmbH
Mercatorstrasse 51
46485 Wesel
Germany

Ireland

LGC Standards
Queens Road
Teddington
Middlesex
TW11 0LY
United Kingdom

India

Italy

LGC Standards S.r.l.
Via Carducci, 39
20099 Sesto San Giovanni (MI)
Italy

Poland

LGC Standards Sp. z o.o.
ul. Ogrodowa 27/29
Kiełpin
05-092 Łomianki
Poland

South Africa

Industrial Analytical & Thistle QA (part of the LGC Group)
48 Monte Carlo Crescent
Kyalami Business Park
Kyalami, Johannesburg
1684 RSA

Spain

LGC Standards S.L.U.
C/Salvador Espriu 59, 2º planta
08005 Barcelona
Spain

UK (Proficiency Testing)

LGC 1 Chamberhall Business Park
Chamberhall Green
Bury
Lancashire
BL9 0AP
United Kingdom

USA & Canada

LGC Standards USA
276 Abby Road
Manchester, NH 03103

USA (Clinical Diagnostics)

LGC Maine Standards
221 US Route 1
Cumberland Foreside
ME 04110
United States of America

USA (Clinical Diagnostics)

SeraCare Life Sciences (R&D)
Suite 150 South Building
910 Clopper Road
MD 20878
Gaithersburg
United States of America

USA & Canada (Proficiency Testing)

American Proficiency Institute (part of the LGC Group)
1159 Business Park Drive
MI 49686
Traverse City
United States of America

Russia

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