162 Part 175—Indirect Food Addi
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A Simple, Fast, and Reliable LC-MS/MS Method for Determination and Quantification of Phthalates in Distilled Beverages
A Simple, Fast, and Reliable LC-MS/MS Method for Determination and Quantification of Phthalates in Distilled Beverages Dimple Shah and Jennifer Burgess Waters Corporation, Milford, MA, USA APPLICATION BENEFITS INTRODUCTION ■■ Separation and detection of 7 phthalates Phthalates, esters of phthalic acid, are often used as plasticizers for polymers such in 11 minutes. as polyvinylchloride. They are widely applicable in various products including personal care goods, cosmetics, paints, printing inks, detergents, coatings, ■■ Simple, quick “dilute and shoot” sample preparation method for routine applications and food packaging. These phthalates have been found to leach readily into the where high sample throughput is required. environment and food as they are not chemically bound to plastics. As such they are known to be ubiquitously present in our environment. ■■ Elimination of major phthalate contamination using the ACQUITY UPLC® Isolator Column. Phthalates have been reported to show a variety of toxic effects related to reproduction in animal studies, which has resulted in these compounds being ■■ Selective mass spectra obtained for all seven considered as endocrine disruptors. Screening food and beverages for phthalates phthalates with dominant precursor ion. contamination is required by many legislative bodies, although regulations vary ■■ Low limits of quantification achieved using from country to country in regards to acceptable daily tolerances and specific Waters® ACQUITY UPLC H-Class System migration limits. and Xevo® TQD. Traditionally, phthalates have been analyzed by gas chromatography-mass ■■ Single and robust method for a variety spectrometry (GC-MS), where derivatization and/or extraction and sample of distilled beverages. preparation is often required to improve chromatographic separation.1 The ■■ Maintain consumer confidence and resulting GC-EI-MS spectra can lack selectivity, where the base ion, used for ensure compliance in market. -
H4R Position on Rosin As One Substance For
H4R Position Statement on Rosin, Rosin Salts and Rosin Esters Registered as One Substance 7th February 2019 REACH registrations of Rosin, Rosin Salts and Rosin Esters H4R Position Statement on One Substance Registration Historically, various names, CAS, and EINECS numbers have existed for rosin. REACH1 mandates “One Substance – One Registration”. This obliged the Rosin registrants to carefully examine the composition of their substances of interest. They concluded that, although Rosin is historically listed under different names and EINECS and CASRNs (e.g. Rosin; Tall-oil rosin; Resin acids and rosin acids; etc.), it needed to be considered as one and the same substance. In addition, the registrants concluded that rosin is a chemical substance of Unknown or Variable Composition, Complex Reaction Products and Biological Materials (UVCB). In other words, rosin was listed on EINECS and CAS under different names, but the rosin registrants determined that differentiation was not justified and appropriate as these are the same UVCB substances. Therefore, Rosin with CAS 8050-09-7 was chosen. Appendix 1 to this document outlines the registrations that cover each of these substances. This decision and its rationale for one rosin registration is well documented in two papers: “Justification for grouping rosin and rosin derivatives into families” by Gary McCallister (Hercules), Bert Lenselink (Hexion), Jerrold Miller (Arizona Chemical), Bill Grady (Arizona Chemical) and Leon Rodenburg (Eastman Chemical), 24 August 20102 “Justification for considering Rosin as a Single Substance” by H4R Consortium, 22 February 20103 Based on these papers, it was concluded that, for rosin and the derived rosin salts, fortified rosin, fortified rosin salts, rosin esters and fortified rosin esters, the starting rosin is not relevant. -
PRICELIST-1920-FINAL.Pdf
INDEX Page No. MD Speech 01 Our Vision / Our Mission 02 Product Classification and Grade Information 03 Label Information 04 GHS Compliance 05 Technical Data Sheet and COA 06 Qualikems Product Range 07 ISO Certificate 08 - 09 Company Details 10 Ordering Information 11 Terms & Conditions 12 Rate List 13 - 52 Images of Lab / Plant / R & D 53 - 58 Rate List 59 -116 BELIEVING yourselfIN IS THE FIRST SECRET TO Success Dear Reader, The document you are holding is the result of work performed by the team of professionals of QUALIKEMS. It is the fruit of our teams extensive technical experience combine with the collaboration of our customers, who have offered us their valuable comments and proposals for improvement. At Qualikems, we have been working and investing for many years with our thoughts focused on the long term. Only thus can this comprehensive catalogue be kept up to date with the products you need. Our highly trained workforce, using state of the art technology, is the driving force behind the management of our modern factory, and our principal aim is to guarantee that the QUALIKEMS product range meets the conditions you require. QUALIKEMS reinforces industrial character and the path to progress we have continuously forged over the years. This path requires the responsible use of resources and the sustainability of our business activity. It is likewise requires and ability to keep on growing as the way to earn and to preserve our status as the leading supplier of laboratory reagents to our Clients Ashok Sahni Managing Director QUALIKEMS FINE CHEM PVT. -
Environmental Protection Agency § 117.3
Environmental Protection Agency § 117.3 (iii) Which are used or could be used (j) Process waste water means any for industrial purposes by industries in water which, during manufacturing or interstate commerce; processing, comes into direct contact (4) All impoundments of waters oth- with or results from the production or erwise defined as navigable waters use of any raw material, intermediate under this paragraph; product, finished product, byproduct, (5) Tributaries of waters identified in or waste product. paragraphs (i) (1) through (4) of this section, including adjacent wetlands; [44 FR 50776, Aug. 29, 1979, as amended at 58 and FR 45039, Aug. 25, 1993; 65 FR 30904, May 15, (6) Wetlands adjacent to waters iden- 2000] tified in paragraphs (i) (1) through (5) of this section (‘‘Wetlands’’ means § 117.2 Abbreviations. those areas that are inundated or satu- NPDES equals National Pollutant rated by surface or ground water at a Discharge Elimination System. RQ frequency and duration sufficient to equals reportable quantity. support, and that under normal cir- cumstances do support, a prevalence of § 117.3 Determination of reportable vegetation typically adapted for life in quantities. saturated soil conditions. Wetlands Each substance in Table 117.3 that is generally included playa lakes, listed in Table 302.4, 40 CFR part 302, is swamps, marshes, bogs, and similar assigned the reportable quantity listed areas such as sloughs, prairie potholes, in Table 302.4 for that substance. wet meadows, prairie river overflows, mudflats, and natural ponds): Provided, TABLE 117.3—REPORTABLE QUANTITIES That waste treatment systems (other OF HAZARDOUS SUBSTANCES DES- than cooling ponds meeting the cri- IGNATED PURSUANT TO SECTION 311 OF teria of this paragraph) are not waters THE CLEAN WATER ACT of the United States. -
Salts of Therapeutic Agents: Chemical, Physicochemical, and Biological Considerations
molecules Review Salts of Therapeutic Agents: Chemical, Physicochemical, and Biological Considerations Deepak Gupta 1, Deepak Bhatia 2 ID , Vivek Dave 3 ID , Vijaykumar Sutariya 4 and Sheeba Varghese Gupta 4,* 1 Department of Pharmaceutical Sciences, School of Pharmacy, Lake Erie College of Osteopathic Medicine, Bradenton, FL 34211, USA; [email protected] 2 ICPH Fairfax Bernard J. Dunn School of Pharmacy, Shenandoah University, Fairfax, VA 22031, USA; [email protected] 3 Wegmans School of Pharmacy, St. John Fisher College, Rochester, NY 14618, USA; [email protected] 4 Department of Pharmaceutical Sciences, USF College of Pharmacy, Tampa, FL 33612, USA; [email protected] * Correspondence: [email protected]; Tel.: +01-813-974-2635 Academic Editor: Peter Wipf Received: 7 June 2018; Accepted: 13 July 2018; Published: 14 July 2018 Abstract: The physicochemical and biological properties of active pharmaceutical ingredients (APIs) are greatly affected by their salt forms. The choice of a particular salt formulation is based on numerous factors such as API chemistry, intended dosage form, pharmacokinetics, and pharmacodynamics. The appropriate salt can improve the overall therapeutic and pharmaceutical effects of an API. However, the incorrect salt form can have the opposite effect, and can be quite detrimental for overall drug development. This review summarizes several criteria for choosing the appropriate salt forms, along with the effects of salt forms on the pharmaceutical properties of APIs. In addition to a comprehensive review of the selection criteria, this review also gives a brief historic perspective of the salt selection processes. Keywords: chemistry; salt; water solubility; routes of administration; physicochemical; stability; degradation 1. -
SALTS of FATTY ACIDS
SALTS of FATTY ACIDS Prepared at the 33rd JECFA (1988), published in FNP 38 (1988) and in FNP 52 (1992). Metals and arsenic specifications revised at the 55th JECFA (2000). An ADI 'not specified' was established at the 33rd JECFA (1988) SYNONYMS INS No. 470 DEFINITION These products consist of calcium, potassium or sodium salts of commercial myristic, oleic, palmitic, stearic, acids or mixtures of these acids from edible fats and oils. The article of commerce can be further specified by: - saponification value, - solidification point for the fatty acids obtained from the salts, - iodine value, - residue on ignition including assay of the cation, and - moisture content Assay Not less than 95% total fatty acid salts, dry weight basis DESCRIPTION Hard, white or faintly yellowish, somewhat glossy and crystalline solids or semi-solids or white or yellowish-white powder FUNCTIONAL USES Anticaking agent, emulsifier CHARACTERISTICS IDENTIFICATION Solubility (Vol. 4) Potassium and sodium salts are soluble in water and ethanol; calcium salts are insoluble in water, ethanol and ether Test for cations Heat 1 g of the sample with a mixture of 25 ml of water and 5 ml of hydrochloric acid. Fatty acids are liberated, floating as a solid or oil layer on the surface which is soluble in hexane. After cooling, aqueous layer is decanted and evaporated to dryness. Dissolve the residue in water and test for the appropriate cation. Fatty acid composition Using the Method of Assay, identify the individual fatty sample. The fatty acid(s) in primary abundance should conform to those declared on the label of the product PURITY Free fatty acids Not more than 3% Measure free fatty acids as directed in the method Free Fatty Acids. -
(12) Patent Application Publication (10) Pub. No.: US 2006/0020077 A1 Miyoshi Et Al
US 20060020077A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0020077 A1 Miyoshi et al. (43) Pub. Date: Jan. 26, 2006 (54) ELECTRICALLY CONDUCTIVE RESIN (30) Foreign Application Priority Data COMPOSITION AND PRODUCTION PROCESS THEREOF Apr. 26, 2000 (JP)...................................... 2000-125081 (76) Inventors: Takaaki Miyoshi, Kimitsu-shi (JP); Publication Classification Kazuhiko Hashimoto, Sodegaura-shi (JP) (51) Int. Cl. C08K 3/04 (2006.01) Correspondence Address: (52) U.S. Cl. .............................................................. 524/495 BRCH STEWART KOLASCH & BRCH PO BOX 747 FALLS CHURCH, VA 22040-0747 (US) (57) ABSTRACT A resin composition comprising a polyamide, a polyphe (21) Appl. No.: 11/203,245 nylene ether, an impact modifier, and a carbon type filler for (22) Filed: Aug. 15, 2005 an electrically conductive use, the filler residing in a phase of the polyphenylene ether. The resin composition of the Related U.S. Application Data present invention has excellent electrical conductivity, flu idity, and an excellent balance of a coefficient of linear (62) Division of application No. 10/240,793, filed on Oct. expansion and an impact resistance, and generation of fines 4, 2002, filed as 371 of international application No. caused by pelletizing thereof can be largely Suppressed PCT/JPO1/O1416, filed on Feb. 26, 2001. when processing of an extrusion thereof is conducted. Patent Application Publication Jan. 26, 2006 US 2006/0020077 A1 FIG. 1 FIG. 2 US 2006/0020077 A1 Jan. 26, 2006 ELECTRICALLY CONDUCTIVE RESIN 0009 From the above-described standpoint, the tech COMPOSITION AND PRODUCTION PROCESS nique wherein improvement in balance of a coefficient of THEREOF linear expansion and an impact resistance can be attained by using a composition Substantially not containing an inor 0001. -
Proposal for Identification of a Substance As a Cmr, Pbt
ECB – SUMMARY FACT SHEET PBT WORKING GROUP – PBT LIST NO. 80 TC NES SUBGROUP ON IDENTIFICATION OF PBT AND VPVP SUBSTANCES RESULTS OF THE EVALUATION OF THE PBT/VPVB PROPERTIES OF: Substance name: Resin acids and Rosin acids, sodium salts EC number: 263-144-5 CAS number: 61790-51-0 Molecular formula: not applicable (substance is a UVCB) Structural formula: not applicable (substance is a UVCB) Summary of the evaluation Resin acids and Rosin acids, sodium salts is considered to be a UVCB substance. Based on screening data it is not fulfilling the PBT/vPvB criteria. Resin acids and Rosin acids, sodium salts is considered as a substance with a potential PBT/vPvB constituent (based on screening data). This conclusion need not apply in case it can be shown, that the concentration of this impurity is < 0.1% w/w. Resin acids and Rosin acids, sodium salts may contain sesquiterpenes (which itself is a mixture) as a constituent, which may fulfil the PBT criteria based on QSAR-estimates of the most common sesquiterpene β –caryophyllane. A test on ready biodegradation is available with Resin acids and Rosin acids, sodium salts showing ready biodegradation of the test substance. The P-screening criterion is therefore not fulfilled. Regarding the B-criterion, only QSAR values are available both with respect to the log Kow and the BCF. BCFwin and Kowwin predict different values for Log Kow; 6.46 and 2.65, respectively. The calculated BCF is 56, when using a log Kow of 6.46 for calculation. The B-screening criterion is therefore not fulfilled. -
Environmental Protection Agency § 117.3
Environmental Protection Agency § 117.3 (4) Applicability date. This paragraph TABLE 117.3—REPORTABLE QUANTITIES OF (i) is applicable beginning on February HAZARDOUS SUBSTANCES DESIGNATED PUR- 6, 2020. SUANT TO SECTION 311 OF THE CLEAN (j) Process waste water means any WATER ACT—Continued water which, during manufacturing or Cat- RQ in pounds processing, comes into direct contact Material egory (kilograms) with or results from the production or use of any raw material, intermediate Ammonium benzoate ...................... D ...... 5,000 (2,270) Ammonium bicarbonate .................. D ...... 5,000 (2,270) product, finished product, byproduct, Ammonium bichromate ................... A ....... 10 (4.54) or waste product. Ammonium bifluoride ...................... B ....... 100 (45.4) Ammonium bisulfite ......................... D ...... 5,000 (2,270) [44 FR 50776, Aug. 29, 1979, as amended at 58 Ammonium carbamate .................... D ...... 5,000 (2,270) FR 45039, Aug. 25, 1993; 65 FR 30904, May 15, Ammonium carbonate ..................... D ...... 5,000 (2,270) 2000; 80 FR 37112, June 29, 2015; 83 FR 5208, Ammonium chloride ........................ D ...... 5,000 (2,270) Feb. 6, 2018] Ammonium chromate ...................... A ....... 10 (4.54) Ammonium citrate dibasic ............... D ...... 5,000 (2,270) Ammonium fluoborate ..................... D ...... 5,000 (2,270) § 117.2 Abbreviations. Ammonium fluoride ......................... B ....... 100 (45.4) NPDES equals National Pollutant Ammonium hydroxide ..................... C -
Chemical Chemical Hazard and Compatibility Information
Chemical Chemical Hazard and Compatibility Information Acetic Acid HAZARDS & STORAGE: Corrosive and combustible liquid. Serious health hazard. Reacts with oxidizing and alkali materials. Keep above freezing point (62 degrees F) to avoid rupture of carboys and glass containers.. INCOMPATIBILITIES: 2-amino-ethanol, Acetaldehyde, Acetic anhydride, Acids, Alcohol, Amines, 2-Amino-ethanol, Ammonia, Ammonium nitrate, 5-Azidotetrazole, Bases, Bromine pentafluoride, Caustics (strong), Chlorosulfonic acid, Chromic Acid, Chromium trioxide, Chlorine trifluoride, Ethylene imine, Ethylene glycol, Ethylene diamine, Hydrogen cyanide, Hydrogen peroxide, Hydrogen sulfide, Hydroxyl compounds, Ketones, Nitric Acid, Oleum, Oxidizers (strong), P(OCN)3, Perchloric acid, Permanganates, Peroxides, Phenols, Phosphorus isocyanate, Phosphorus trichloride, Potassium hydroxide, Potassium permanganate, Potassium-tert-butoxide, Sodium hydroxide, Sodium peroxide, Sulfuric acid, n-Xylene. Acetone HAZARDS & STORAGE: Store in a cool, dry, well ventilated place. INCOMPATIBILITIES: Acids, Bromine trifluoride, Bromine, Bromoform, Carbon, Chloroform, Chromium oxide, Chromium trioxide, Chromyl chloride, Dioxygen difluoride, Fluorine oxide, Hydrogen peroxide, 2-Methyl-1,2-butadiene, NaOBr, Nitric acid, Nitrosyl chloride, Nitrosyl perchlorate, Nitryl perchlorate, NOCl, Oxidizing materials, Permonosulfuric acid, Peroxomonosulfuric acid, Potassium-tert-butoxide, Sulfur dichloride, Sulfuric acid, thio-Diglycol, Thiotrithiazyl perchlorate, Trichloromelamine, 2,4,6-Trichloro-1,3,5-triazine -
Gasket Chemical Services Guide
Gasket Chemical Services Guide Revision: GSG-100 6490 Rev.(AA) • The information contained herein is general in nature and recommendations are valid only for Victaulic compounds. • Gasket compatibility is dependent upon a number of factors. Suitability for a particular application must be determined by a competent individual familiar with system-specific conditions. • Victaulic offers no warranties, expressed or implied, of a product in any application. Contact your Victaulic sales representative to ensure the best gasket is selected for a particular service. Failure to follow these instructions could cause system failure, resulting in serious personal injury and property damage. Rating Code Key 1 Most Applications 2 Limited Applications 3 Restricted Applications (Nitrile) (EPDM) Grade E (Silicone) GRADE L GRADE T GRADE A GRADE V GRADE O GRADE M (Neoprene) GRADE M2 --- Insufficient Data (White Nitrile) GRADE CHP-2 (Epichlorohydrin) (Fluoroelastomer) (Fluoroelastomer) (Halogenated Butyl) (Hydrogenated Nitrile) Chemical GRADE ST / H Abietic Acid --- --- --- --- --- --- --- --- --- --- Acetaldehyde 2 3 3 3 3 --- --- 2 --- 3 Acetamide 1 1 1 1 2 --- --- 2 --- 3 Acetanilide 1 3 3 3 1 --- --- 2 --- 3 Acetic Acid, 30% 1 2 2 2 1 --- 2 1 2 3 Acetic Acid, 5% 1 2 2 2 1 --- 2 1 1 3 Acetic Acid, Glacial 1 3 3 3 3 --- 3 2 3 3 Acetic Acid, Hot, High Pressure 3 3 3 3 3 --- 3 3 3 3 Acetic Anhydride 2 3 3 3 2 --- 3 3 --- 3 Acetoacetic Acid 1 3 3 3 1 --- --- 2 --- 3 Acetone 1 3 3 3 3 --- 3 3 3 3 Acetone Cyanohydrin 1 3 3 3 1 --- --- 2 --- 3 Acetonitrile 1 3 3 3 1 --- --- --- --- 3 Acetophenetidine 3 2 2 2 3 --- --- --- --- 1 Acetophenone 1 3 3 3 3 --- 3 3 --- 3 Acetotoluidide 3 2 2 2 3 --- --- --- --- 1 Acetyl Acetone 1 3 3 3 3 --- 3 3 --- 3 The data and recommendations presented are based upon the best information available resulting from a combination of Victaulic's field experience, laboratory testing and recommendations supplied by prime producers of basic copolymer materials. -
Polyvinylchloride, Phthalates and Packaging
Page 29 | Bulletin 86 | July 2014 Polyvinylchloride, phthalates and packaging Plastics are synthetic resins, are either thermosetting or thermoplastic. Thermoplastic resins can be re-softened by heating, and include polyethylene (PE), polystyrene (PS), polypropylene (PP), and polyvinylchloride (PVC) which is very widely used in disposable medical devices. Polyvinylchloride (PVC) Di(2-ethylhexyl) phthalate (DEHP) Vinyl chloride (CH2=CHCl or chloroethylene) DEHP (sometimes referred to as bis is polymerized by free-radical initiators to (2-ethylhexyl) phthalate) is the diester of open the double bond and to link together phthalic acid and 2 ethylhexanol (Figure 2). vinyl chloride monomers, to form repeating Dr A M Walton units of polymers (Figure 1). Figure 2 The structure of di(2-ethylhexyl) phthalate DEHP. Anaesthesia ST 7, Figure 1 The phthalic moiety is common to all phthalates; University Hospital The chemical structure of vinyl chloride and PVC the pair of symmetrical aliphatic chains depends Southampton on the esterified alcohol PVC is a rigid structure at room temperature. Heating gives the molecules energy, widens the distance between between the molecules and softens the resin. To give PVC flexibility at room and body temperatures, plasticisers Dr J M T Pierce are added non-covalently to the PVC when Consultant Anaesthetist, At room temperature it is a colourless, oil- University Hospital molten and serve as molecular spacers so soluble viscous liquid and is used to form Southampton; RCoA when cooled the polymer has a softness even up to 40% of the mass of the PVC product. Environmental Advisor at room temperatures. The most commonly The annual global production of DEHP is used plasticisers are phthalates.