Active pharmaceutical ingredient valsartan, common in blood pressure medication, has been in the news recently, as recalls are issued worldwide for valsartan products comtaminated with carcinogen N-nitrosodimethylamine (NDMA). We look at NDMA's history as a contaminant and explore why regular testing and analysis of pharmaceutical products is so vital.
Thursday, July 19, 2018
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Extractables and Leachables (E&L): analysis is an essential component in many fields, but mainly though in food safety and the pharmaceutical industry.
Friday, July 21, 2017
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And the right answer is: It depends on the situation!
We know that there is still the “rumour” out in the analytical community, that you can take the assay of compendial standards as 100% when nothing is written on the label.
Thursday, July 20, 2017
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“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. Some even assume that there has a degradation happened with the reference material they have applied.
Tuesday, February 28, 2017
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Use our monthly pharmacopoeial lot lists to easily monitor the expiry dates of your stocked reference materials.
Friday, February 24, 2017
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To help you further increase your knowledge and performance, we have designed the seminar 'Pharmaceutical quality control: tips, tools & tactics'. This 1.5 day course focuses on those specific (and often least understood) areas where a deeper knowledge of pharmaceutical reference standards will give you a real advantage.
Tuesday, January 24, 2017
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How to easily monitor expiry dates from EP, EPISA, ICRS, USP and BP reference standards.
Friday, January 20, 2017
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Regulatory guidance on reference standards for impurities is less detailed than that provided for Active Pharmaceutical Ingredients (API), for example. Hence, users are often unsure which is the correct impurity reference standard for their specific purpose.
Friday, January 13, 2017
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Here's a new list of pharmacopoeial reference materials from EP, EPISA, ICRS, USP and BP, including current lot numbers.
Monday, December 19, 2016
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Check out our new catalogue supplement including our newly produced pharmaceutical impurity reference standards.
Friday, December 16, 2016
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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.
Thursday, November 17, 2016
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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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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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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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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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The British Pharmacopoeia (BP) has recently announced a new expiry date policy.
Wednesday, September 21, 2016
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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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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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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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Need to monitor the expiry dates of your stocked pharmaceutical reference materials?
Thursday, July 21, 2016
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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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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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Need to monitor the expiry dates of your stocked pharmaceutical reference materials?
Tuesday, June 21, 2016
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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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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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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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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
Read more..Need to monitor the expiry dates of your stocked pharmaceutical reference materials?
Monday, May 23, 2016
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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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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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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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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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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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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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Need to monitor the expiry dates of your stocked pharmaceutical reference materials?
Friday, February 19, 2016
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On 27 January 2016, the FDA updated their Bioequivalence (BE) Recommendations for specific products.
Monday, February 01, 2016
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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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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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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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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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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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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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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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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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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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“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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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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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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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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Recent developments at ICH, EMA and FDA
Friday, March 22, 2013
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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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On October 20th, 2016 ASTM International published ASTM F963-16 Standard Consumer Safety Specification for Toy Safety, an updated version of ASTM F963-11. The aim of this revision is to address various issues relating to toy safety, ideally highlighting and eliminating many potential hazards from toys intended for use by children under the age of 14.
Friday, January 13, 2017
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Oils and fats represent one of the three major classes of food constituents together with carbohydrates and proteins. Deep-fat frying is one of the most popular cooking procedures and leads to the production of both desirable and undesirable compounds.
Monday, December 05, 2016
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In September 2016, the E.U. Commission presented an amended regulation proposal for acrylamide, based on feedback from the stakeholders’ consultation. The Regulation is proposed to be made under Article 4 of Regulation (EC) No. 852/2004 on the hygiene of foodstuffs, and it sets out a requirement for food business operators to take account of strict new codes of practice for reducing acrylamide formation, as part of their food safety management systems.
Wednesday, November 09, 2016
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