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Monthly Archives: January 2014

2801, 2014

Faulty Packaging Requires Complete Recall of Liptruzet – Analytical Chemistry Can Provide the Answers to Get the Drug Back on the Market

January 28th, 2014|Blog|

On Jan 14th, 2014, Merck & Co. issued a voluntary recall of the cholesterol drug Liptruzet. What made this specific recall unique is that it was not focused on a single lot, or even several that had been distributed, but on all of the lots of the drug that were produced since the product’s launch in May of 2013.

The reason for this recall was a packaging defect. The product’s packing has outer pouches made of laminate foil which were found to potentially let moisture seep into the sealed packages and affect the tablets. Merck claimed that the defect is unlikely to decrease the drug’s effectiveness, nevertheless the drug is planned to be completely removed from market for the foreseeable future until the packaging defect can be corrected.

Recalls due to manufacturing defects are not uncommon. When a defect occurs after the product is already on the market, companies must act quickly to discover the cause of the defect and correct the manufacturing process. Chemical analysis of both the pharmaceutical product and its packaging can reveal the source of the defect, and any associated contamination or health risks. Since, in the case of Liptruzet, the packaging is thought to be defective and not the tablets themselves, much of the analysis will progress as a typical manufacturing failure analysis. Since it is a pharmaceutical product, however, documentation of manufacturing changes must be submitted to the FDA for review before the product can be cleared again to enter the market.

Avomeen’s scientists suggest that companies who experience similar pharmaceutical product defects should consider employing the following corrective measures:

• Initiate a product recall and inform the FDA
• Perform contamination testing on the drug product to determine safety and potency of the product still on the market
• Conduct a failure analysis on the product’s packaging to determine the cause of the defect
• Correct manufacturing issues and revise methodology
• Submit any post approval product changes to the FDA for consideration to restart manufacturing

Manufacturers and pharmaceutical companies use Avomeen Analytical Services to perform preventative testing before a defect occurs and to conduct failure analysis services when defects are found during production. These analytical services identify the source of product defects and correct the issue so production can continue.

Learn more about Pharmaceutical Analysis, and Failure Analysis.

Contact Avomeen Analytical Services at 800.930.5450 for a free consultation with one of our Ph.D. Chemists.

1001, 2014

The Composition of Ice Melting Products and the Active Ingredients That Make Them Effective

January 10th, 2014|Blog|

Commercial ice melting products have become very popular with consumers looking to transfer the blunt of the labor involved in clearing snow and ice during the winter months to an easy to use product. New advancements allow these innovative products to remove thick ice buildups, even during the tough conditions present during ‘Hercules’, which is the ‘polar vortex’ currently affecting those in a large portion of the country.

These products generally contain various combinations of Potassium Chloride, Sodium Chloride, Magnesium Chloride and Calcium Chloride which work by mixing with the water that is already present in the environment to create a brine solution. This solution then spreads under the ice and breaks the surface bond which allows the remaining ice or snow to be easily removed manually. The brine also prevents new layers of ice or snow from adhering to the surface.

Sodium Chloride, Potassium Chloride, Ammonium Sulfate, Ammonium Nitrate and Urea work by absorbing heat from their environment; while Calcium Chloride and Magnesium Chloride release heat upon contact with water. These chemicals allow the ice melting products to function primarily by depressing the freezing point of water.

These compounds however are only effective for use within certain temperature ranges. Their lowest temperature limits are as follows:

• Potassium Chloride (12° F)
• Urea (15° F)
• Sodium Acetate (5° F)
• Sodium Chloride (20-22° F)
• Calcium Chloride (-25° F)
• Magnesium Chloride (5° F)
• Calcium Magnesium Acetate (5° F)

The effectiveness of a de-icing product is determined by a number of factors, primarily which combination of active ingredients is included in the product’s formulation and at what quantities. Other common issues to consider during the R&D of an ice melting product are the environmental implications and surface corrosion that these products can produce.

Avomeen’s chemical laboratory specializes in the testing and development of consumer products. Our skilled chemists can perform a competitor product analysis to determine the true differences between current products on the market. This data can then be used to develop a new formulation that is customized towards meeting your customer’s specific needs and is superior to the existing products currently on the market. One common critique of ice melting products is their lack of product labeling clarity and the performance claims made versus its actual effectiveness. Our laboratory can also perform the testing necessary to ensure that your product’s marketing claims are accurate.

A complete list of our analytical testing services is available here.