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FDA Requires Release Testing of Ranitidine and Nizatidine Due to NDMA Impurity

Dec 10 2019

On December 4, 2019, FDA announced that ongoing testing of OTC and prescription ranitidine (commonly known as Zantac) and nizatidine products is required due to the detection of an N-nitrosodimethylamine  (NDMA) impurity. NDMA Impurity Testing in Ranitidine (Zantac) and Nizatidine Several weeks ago, FDA launched an investigation to: Understand the source of the NDMA impurity…


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Developing GC-FID Methods for Volatile HPHC Components in E-Liquids Poster Presentation

Dec 10 2019

Avomeen’s E-Liquids Analysis team attended the 2019 Eastern Analytical Symposium and presented a poster on The Development of GC-FID Methods for the Detection and Quantification of Volatile HPHC Components in E-Liquids. If you weren’t able to make it to the show, we’ve got you covered. Additional Resources To help you understand some of the important methods…


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Verifying Your Plastic Recycling Process for Food Contact

Dec 5 2019

Post-Consumer Plastic Food Contact Testing The FDA regulates the use of plastics that contact food and under the Code of Federal regulations 21 CFR 177 provides for testing of polymers that are used to package, store, and hold food.   These CFR codes apply only to virgin plastic materials.  Post-consumer plastics provide a unique challenge as…


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Applying for Food Contact Approval in the US

Nov 26 2019

Any new material that is to be marketed for an application that has direct or indirect contact with food in the US requires a pre-marketing approval from the FDA.   This includes new packaging materials, new baking or cooking materials, coatings for beverage cans and other drinkable liquid containers, and inks and adhesives that go on…


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The Path to Affordable Biologic Drugs: Analytical Considerations

Nov 22 2019

Recently, I went to the pharmacy and paid twenty-two dollars for a generic statin prescription.  A related statin as a new brand might cost six hundred dollars.  While I earn my daily keep in the biopharma services sector and appreciate why drugs cost so much, this made me happy as a consumer. The Role of…


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What You Need to Know About the COSMOS-Standard for Natural & Organic Cosmetic Products

Nov 19 2019

What is the COSMOS-Standard? COSMOS (“COSMetic Organic and Natural Standard”) is a single, international standard for natural and organic cosmetic products which became effective in January of 2010. The five foremost organizations involved in organic and natural cosmetics standards came together to develop a single, harmonized standard to ensure: A level playing field Efficient operation…


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FDA Grants First-Ever Modified Risk Orders for Smokeless Tobacco Products

Nov 14 2019

FDA recently granted the first-ever modified risk orders to eight smokeless tobacco products. In a recent press release, FDA announced the authorizations are for Swedish Match USA, Inc. snus smokeless tobacco products, which are marketed and sold under the “General” brand name. The Products were Previously Authorized Under PMTA The 8 snus smokeless tobacco products…


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Best-In-Class Polymer Additive Library for Identification of Extractables

Nov 12 2019

In the biopharmaceutical industry, it’s important to identify extractables and leachables for patient safety and submissions to regulatory authorities.  Impurities can originate from process components, manufacturing equipment, packaging materials, and container closure systems used in the development of a drug product. Extractable and leachables (E&L) studies detect and identify the organic and inorganic compounds that…


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Development of a Library of Plastic Additives for Identification of Extractables Poster Presentation

Nov 5 2019

Avomeen’s extractables and leachables (E&L) team are attending AAPS PharmSci360 November 3-6, 2019 in San Antonio, Texas. If you’re able to attend, be sure to check out our poster, Development of a Library of Plastics Additives for Identification of Extractables. If you can’t make it to the show, we’ve got you covered. Additional Resources The FDA…


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Development and Validation of In Vitro Release Test (IVRT) Method for Ophthalmic Suspensions Poster Presentation

Nov 4 2019

Avomeen’s pharmaceutical formulation team are attending AAPS PharmSci360 November 3-6, 2019 in San Antonio, Texas. If you’re able to attend, be sure to check out our poster, Development and Validation of In Vitro Release Test (IVRT) Method for Ophthalmic Suspensions – A Walkthrough Exercising Regulatory Guidance. If you can’t make it to the show, we’ve got…


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