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Pharmaceutical blog archive

November lot list: Monitor your pharmacopoeial standards

Have you already tried our free tool for easy tracking of expiry dates of your stocked pharmacopoeial reference standards?

Thursday, November 17, 2016

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New lots in October: Monitor your pharmacopoeial standards

Have you already tried our free tool for easy tracking of expiry dates of your stocked pharmacopoeial reference standards?

Wednesday, October 19, 2016

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New pharmaceutical reference standards in October

Here's a new catalogue supplement for you to help you keep up to date with the latest pharmaceutical reference standards. The interactive supplement makes buying pharmaceutical reference standards easy for you: Simply click on the product code to get to our web shop.

Wednesday, October 12, 2016

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Expiry dates: Monitor your pharmacopoeial standards

Have you already tried our free tool for easy tracking of expiry dates of your stocked pharmacopoeial reference standards?

Thursday, September 22, 2016

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BP changes expiry date policy

The British Pharmacopoeia (BP) has recently announced a new expiry date policy.

Wednesday, September 21, 2016

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Reference standards: Find out what is new in September

We’ve got a new catalogue supplement for you to help you keep up to date with the latest reference standards.

Monday, September 19, 2016

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How to easily track expiry dates of your reference standards

Are you looking for a tool for easy tracking of expiry dates of your stocked pharmaceutical reference materials?

Wednesday, August 24, 2016

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ICH Q3D: Health Canada releases recommendations for implementation

The Canadian Authorisation and Monitoring Authority has recently released a “Q3D notice” on their website. In this recommendation they explain which data are expected in applications for registrations, for new marketing authorisations of medicinal products or OTC products and in variation applications for already marketed products.

Wednesday, August 24, 2016

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Download our August catalogue supplement

We have just released our August catalogue supplement to inform you about our newly produced pharmaceutical reference standards. It includes over 1,100 new products since the release of our last paper catalogue.

Wednesday, August 24, 2016

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Monitor your batches: July lot list available now

Need to monitor the expiry dates of your stocked pharmaceutical reference materials?

Thursday, July 21, 2016

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New: Monthly catalogue supplements

From July onwards we will release monthly catalogue supplements to inform you about our newly produced pharmaceutical reference standards. The monthly supplement includes all new reference standards since the release of our last paper catalogue. It is an interactive PDF, so if you want to buy a reference standard, all you have to do is click on the product code to get to our web shop.

Thursday, July 21, 2016

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FDA releases new draft guidance on elemental impurities

On 30 June the US Food and Drug Administration (FDA) published a new draft guidance on elemental impurities in drugs, to help manufacturers comply with recent International Council for Harmonisation (ICH) and United States Pharmacopeial Convention (USP) standards.

Thursday, July 21, 2016

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Monitor your batches: June lot list available now

Need to monitor the expiry dates of your stocked pharmaceutical reference materials?

Tuesday, June 21, 2016

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Join our extractables and leachables seminar

We are offering a free summer seminar on extractables and leachables, which will be taking place on Wednesday 13 July at the LGC site in Fordham, Cambridgeshire, UK.

Tuesday, June 21, 2016

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Bioequivalence testing: New FDA draft guidance for 19 generics and 19 revisions

On 16 June, the US Food and Drug Administration (FDA) released 38 new and revised draft guidance documents for drug manufacturers for new generics, as well as for some blockbuster drugs that are still patented.

Tuesday, June 21, 2016

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Hot off the press: Our 2016 Pharma catalogue supplement

We have just released a new catalogue supplement ‘Pharmaceutical impurities and primary standards 2016’ which includes more than 1,100 reference standards for impurity and active pharmaceutical ingredient (API) testing for pharmaceutical quality control. This new supplement is an addendum to our previous ‘Pharmaceutical impurities and primary standards’ catalogue, which was released in March 2015.

Monday, May 23, 2016

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Proficiency testing in the pharmaceutical industry: residual solvents quantification

Solvents – organic volatile chemicals – are often essential components in the manufacture of pharmaceutical products: during synthesis, purification, crystallization, granulation or coating. They may also indirectly enter products from packaging and during storage.

Monday, May 23, 2016

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Monitor your batches: May lot list available now

Need to monitor the expiry dates of your stocked pharmaceutical reference materials?

Monday, May 23, 2016

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Bioequivalence testing: FDA releases new recommendations in April

From Albendazole to Valganciclovir: Since April the FDA has released 44 new product-specific bioequivalence recommendations for the development of generic drug products.

Friday, April 22, 2016

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Monitor your batches: April lot list available now

Need to monitor the expiry dates of your stocked pharmaceutical reference materials? LGC publishes free monthly 'lot lists' containing information on batches from EP, ISA, ICRS, USP and BP.

Tuesday, April 19, 2016

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World Parkinson’s Day: How LGC can help develop new medications

Today is World Parkinson’s Day. With the current medical knowledge, Parkinson can be treated effectively, but there is no final cure at this stage.

Monday, April 11, 2016

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Monitor your batches with our March lot list

Need to monitor the expiry dates of your stocked reference materials? Here's the March 'lot list' containing information on batches from EP, ISA, ICRS, USP and BP.

Wednesday, March 23, 2016

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FDA: Guideline on drugs with estrogenic, androgenic, or thyroid activity published

This month, the Food and Drug Administration (FDA) has published a guideline called 'Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity'.

Wednesday, March 23, 2016

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Are you up to date on the latest anti-Parkinsonian reference standards?

Monday 11 April 2016 is World Parkinson’s Day. According to the Parkinson’s Disease Foundation, an estimated seven to 10 million people worldwide are living with Parkinson's disease, a chronic and progressive movement disorder, meaning that symptoms continue and worsen over time.

Wednesday, March 23, 2016

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Monitor your batches with our free February lot list

Need to monitor the expiry dates of your stocked pharmaceutical reference materials?

Friday, February 19, 2016

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New FDA recommendations for bioequivalency studies

On 27 January 2016, the FDA updated their Bioequivalence (BE) Recommendations for specific products.

Monday, February 01, 2016

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Why pharmacopoeial reference standards are restricted in their use

When it comes to pharmacopoeial reference standards, there is still uncertainty as to their proper application areas. This post looks at their limitations in pharmaceutical quality control.

Wednesday, December 09, 2015

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Hot off the press: Impurity testing beyond pharmacopeial methods

We have just released a new catalogue ‘Impurity testing beyond pharmacopeial methods’ to help you find the correct impurity reference standard when non-pharmacopoeial methods have to be applied.

Wednesday, November 18, 2015

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Pharmacopoeias: Not the only source of primary standards for pharmaceutical QC

At times, information from the market suggests that Pharmacopoeias such as United States Pharmacopeia (USP), European Pharmacopoeia (EP) etc. are the only source of primary reference standards for pharmaceutical quality control.

Tuesday, November 17, 2015

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Get the free slides from our talk at CPhI/ICSE in Madrid

Have you missed our talk ‘Reference standards in analytical quality control: Limitations of official materials and alternative solutions’ at CPhI in Madrid?

Tuesday, October 20, 2015

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New FDA Guidance refers to ICH Guideline Q2(R1) as primary reference

The new FDA Guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” includes several recommendations on reference material usage. Following on from our previous blog post, we have pulled out a second recommendation for you:

Monday, October 19, 2015

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FDA recommends to strictly follow applications of reference materials

The final FDA Guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” includes several recommendations on reference material usage in section V.

Wednesday, September 09, 2015

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New FDA Guidance to Industry published as final

On July 24, FDA released a final Guidance to Industry entitled “Analytical Procedures and Methods Validation for Drugs and Biologics”.

Tuesday, September 08, 2015

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Performing the dissolution test

Many customers perform the dissolution test procedure as per United States Pharmacopoeia (USP) general chapter <711> by using Prednisone tablets as reference standard. However, we are often asked for advice by customers who have found too high values which are out of specification.

Tuesday, October 15, 2013

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USP particle count set: New lot comes with tighter values

The United States Pharmacopoeia (USP) has now launched a new batch for the USP particle count set (L0L142). Important: This new lot has narrower limits than the previous lot (K0H089) which remains valid until 01/2014!

Monday, May 06, 2013

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Assay value found below specification?

“The result I’ve found for the assay value in my API or finished dosage form is below my specification. Is there a problem with my reference standard?” is an often asked question by users of pharmaceutical reference materials.

Tuesday, April 23, 2013

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Do pharmacopoeial substances need to fulfill content specifications of their own monographs?

Sometimes we are approached by customers, who are finding it strange that some pharmacopoeial reference standards for drug substances do not seem to fulfill the specifications for the monographs they are established for.

Monday, April 15, 2013

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One mistake not to make on assay calculation

Recently, a customer asked us for advice on assay calculation of Oxytetracycline Hydrochloride by using reference materials from the European Pharmacopoeia (Ph. Eur.).

Tuesday, April 09, 2013

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New batch sometimes requires new test method

A customer used a Ph. Eur. reference standard for a test on related substances with the HPLC method described in the monograph, but could not see the impurity peak in the chromatogram when using a

Tuesday, April 02, 2013

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News from the impurity front

Recent developments at ICH, EMA and FDA

Friday, March 22, 2013

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USP chapters on elemental impurities now official

According to a note on the USP website, the „USP General Chapters <232> Elemental Impurities – Limits and “<233> Elemental Impurities – Procedures” are now official since February 1, 2013.

Tuesday, February 26, 2013

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Proficiency Testing blog archive

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