Extractables and leachables in pharmaceutical packaging (USP 1663 & USP 1664)

Qualitative identification of chemical groups in solid samples by Attenuated total reflectance Fourier-transform infrared spectroscopy (ATR-FTIR). Results will be delivered as an FTIR spectrum. In addition, a comparison to an FTIR library will be provided. The method is not quantitative, but it can be used to identify the main chemical components of the sample.

Imaging of the sample using a scanning electron microscope (SEM) with energy-dispersive X-ray spectroscopy (EDX or EDS). Typically, several images are taken with varying magnifications to get a good overview of the sample. An EDX mapping, line scan, or point measurement is collected to measure the sample composition (elemental at.% or wt.%). Non-conductive samples can be prepared with a metallic coating. For cross-section measurement, additional preparation might be needed: FIB, BIB, or freeze fracturing.

UPLC-MS/MS analysis for determining the melatonin content in dietary supplements. According to Regulation (EU) No 432/2012, melatonin supplements may be marketed with the following health claims: "Melatonin contributes to the alleviation of subjective feelings of jet lag." The claim can be used if the product contains at least 0.5 mg of melatonin per portion., "Melatonin contributes to the reduction of time taken to fall asleep." The claim can be used if the product contains at least 1 mg of melatonin per portion..

Printing ink set-off can occur on the reverse side of printed labels, lids, cups, and packaging film, either in a stack or in the reel after printing. This creates a potential for low-molecular-weight substances to transfer to the unprinted surface of the packaging that makes contact with the packed contents. We offer two food simulant options for set-off testing: Ethanol solution for plastic and polymer-coated materials, Simulant E (Tenax) for the above and paper and board. The price includes a simple risk assessment based on the Swiss Ordinance for printing inks (SR 817.023.21), EU regulations for food contact materials, and EFSA's Threshold of Toxicological Concern (TTC) approach. More extensive risk assessment is available upon request.

This test is designed to measure the oxygen transmission rate of finished packages, including cups, bottles, trays, and containers. Two replica measurements are included in the displayed price. Temperature can be adjusted from 15 to 55 °C, and relative humidity can be either 0% or between 5 and 90% RH. This test is not suitable for films. Please see the oxygen transmission rate (OTR) of films and sheeting if you need testing for film samples. Please specify the sample dimensions and testing conditions upon ordering.

Migration of lead and cadmium from ceramics, glass, and enameled articles. For ceramic articles and tableware, limits defined in Commission Directive 2005/31/EC (amending Council Directive 84/500/EEC) apply: Category Limit for lead Limit for cadmium Articles which cannot be filled and articles which can be filled, the internal depth of which, measured from the lowest point to the horizontal plane passing through the upper rim, does not exceed 25 mm 0.8 mg/dm2 0.07 mg/dm2 All other articles which can be filled 4.0 mg/l 0.3 mg/l Cooking ware; packaging and storage vessels having a capacity of more than three liters 1.5 mg/l 0.1 mg/l In addition, limits for the release of lead (2 mg/article) and cadmium (0.2 mg/article) for articles with a lip and rim area (such as cups and mugs) have been defined in standard ISO 4531-1/2:1998. For glass and enameled products, no harmonized regulation exists currently within the European Union. By convention, limits defined by Commission Directive 2005/31/EC can be applied. However, member states can impose additional or separate restrictions regarding migration limits, tested elements, and/or test conditions. Examples of specific requirements defined at the national level are listed below: Member state Regulation Specific requirements* France Fiche MCDA n°2 (V01 – 01/05/2016) Ceramics & glass: separate migration limits for articles with a lip and rim area, migration limits for Al, Co, and As. Enameled and decorated articles other than ceramics: migration limit for Cr VI. Italy Ministerial Decree of 21/03/1975, as amended Lead glass: separate test method and migration limit for Pb. The Netherlands Commodities Act (Packagings and Consumer Articles) Glass and glass ceramics: separate migration limits for Sb, As, Ba, B, Cd, Ce, Cr, F, Co, Li, Pb, Mn, Ni, Rb, Zr. Ceramics and enamels: separate migration limits for As, Ba, B, Cd, Cr, Co, Hg, Li, Pb, Rb, Se, Sr. Finland Degree (KTM) 268/1992 Glass, enamels, and ceramics with lip and rim area and/or intended for toddlers: separate migration limits for Pb, Cd, Ni, Cr. * Testing for specific requirements is possible for an additional cost Some of the available test methods are listed below: Material type Product type Migration method Available methods Ceramics Flatware (e.g. plates) Total immersion EN 1388-1, ASTM C 738 Ceramics Holloware (e.g. cups) Article fill EN 1388-1, ASTM C 738 Glass Flatware (e.g. plates) Total immersion EN 1388-2 Glass Holloware (e.g. cups) Article fill ISO 7086-1 Ceramics, glass, enameled metal Holloware (e.g. cups) Lip and rim test ASTM C 927

Phthalates are a group of chemicals widely used as plasticizers, which make plastics more flexible and durable. They have also been used as additives in products such as cosmetics and personal care items. Several phthalates have been identified as endocrine-disrupting agents or as chemicals toxic to reproduction. Exposure to phthalates can occur through: Oral exposure Food: Exposure occurs via migration from food packaging., Children's toys: Children often put toys in their mouths.., Inhalation: Breathing in dust from vinyl flooring or fragrances (like perfumes) can cause exposure to phthalates via inhalation., Skin contact: Phthalates present in cosmetics, lotions, and soaps can be absorbed through the skin.. For other listed matrices apart from cosmetics, the analysis package covers the following substances included in the REACH Authorization List: Substance Abbreviation CAS number Diisobutyl phthalate DIBP 84-69-5 Dibutyl phthalate DBP 84-74-2 Benzyl butyl phthalate BBP 85-68-7 Bis(2-ethylhexyl) phthalate DEHP 117-81-7 Di(n-octyl) phthalate DNOP 117-84-0 Diisononyl phthalate DINP 68515-48-0 Diisodecyl phthalate DIDP 26761-40-0 Products that contain restricted phthalates in concentrations higher than 0.1% may be removed from the market. The analysis package for cosmetic products contains the following phthalates: Substance Abbreviation CAS number Bis(2-ethylhexyl) phthalate DEHP 117-81-7 Benzyl butyl phthalate BBP 85-68-7 Dibutyl phthalate DBP 84-74-2 Diisononyl phthalate DINP 68515-48-0 Di(n-octyl) phthalate DNOP 117-84-0 Diisodecyl phthalate DIDP 26761-40-0 All the above-mentioned substances are prohibited in cosmetic products (Annex II of Regulation (EC) No 1223/2009).

Analysis for quantifying dioxins and furans (PCDD/F) in various packaging materials (e.g. food and cosmetics packaging) and their raw materials, including plastics, paper, and rubber. Dioxins and furans are a family of chlorine-containing chemicals considered bioaccumulating, persistent organic pollutants (POPs) that can be toxic even at low doses. While regulatory limits apply mainly to food and feed, packaging materials can be a source of indirect exposure to dioxins and furans. Recycled materials tend to pose relatively high risks, depending on the quality of the raw material and the effectiveness of the decontamination process. The following substances are included in the analysis: Dibenzo-p-dioxins (PCDDs) Polychlorinated dibenzofurans (PCDFs) 2,3,7,8-TCDD. 2,3,7,8-TCDF. 1,2,3,7,8-PeCDD. 1,2,3,7,8-PeCDF. 1,2,3,4,7,8-HxCDD. 2,3,4,7,8-PeCDF. 1,2,3,6,7,8-HxCDD. 1,2,3,4,7,8-HxCDF. 1,2,3,7,8,9-HxCDD. 1,2,3,6,7,8-HxCDF. 1,2,3,4,6,7,8-HpCDD. 1,2,3,7,8,9-HxCDF. OCDD. 2,3,4,6,7,8-HxCDF. 1,2,3,4,6,7,8-HpCDF. 1,2,3,4,7,8,9-HpCDF. OCDF. Testing is often performed for the following reasons: Analyzing recycled PE, PP, and LDPE intended for cosmetics packaging according to CosPaTox guidelines., Analyzing paper and board bleached with elementary chlorine according to the requirements of TemaNord 2008:515 guidelines..

Determination of the total organic fluorine (TOF) content in combustible materials using combustion ion chromatography (CIC). By default, TOF is analyzed as total fluorine (TF). If required, total inorganic fluorine (TIF) can be measured as well, and TOF calculated as the difference between TF and TIF. TOF analysis gives information about the total amount of organic fluorinated compounds. It can also be used to evaluate the presence of per- and polyfluoroalkyl substances (PFAS) in the material, even though individual PFAS compounds can't be analyzed with this method. The analysis is suitable for many different materials. Please describe the sample in detail when requesting an offer to help us prepare a quote quickly.

Determination of the water vapor transmission rate (WVTR) of ultra-high barrier materials. The method can also be used to test moderate barrier materials at high-temperature conditions. Please disclose the desired temperature (from 10 to 85 °C) and the desired relative humidity (from 60% to 100%) when placing the order. This measurement is applicable for films and sheeting materials with WVTR values between 1x10-6 and 10 g/m2/day. If you wish to test finished packaging instead, check out the WVTR measurement for packages. The price of the test consists of a flat rate cost per sample plus one day measurement time. Please contact our experts for an offer.