235 results about "Related impurities" patented technology

Disclosed herein is an electrically conductive precursor composition comprising an organic polymer precursor; a single wall nanotube composition, wherein the single wall nanotube composition contains at least 0.1 wt % of production related impurities; and an optional nanosized conductive filler. A conductive composition comprises an organic polymer; a single wall nanotube composition, wherein the single wall nanotube composition contains at least 0.1 wt % of production related impurities; and a nanosized conductive filler.

The invention described herein provides new methods of preparing purified Factor VII polypeptide drug substances in large quantities (industrial scale levels) that are associated with reduced content of product-related impurities (e.g., late eluting peaks) and/or that exhibit a relatively uniform glycosylation pattern.

Disclosed herein is an electrically conductive composition comprising an organic polymer; and a carbon nanotube composition, wherein the carbon nanotube composition comprises carbon nanotubes that can rope and have greater than or equal to about 0.1 wt % production related impurities, based on the total weight of the carbon nanotube composition, and wherein the composition has a bulk volume resistivity less than or equal to about 10¹² ohm-cm, and a notched Izod impact strength of greater than or equal to about 5 kilojoules/square meter.

The invention relates to a method for producing a wear-resistant aluminum alloy, to an aluminum alloy produced according to the method, and to the use thereof. The method comprises the steps of: (i) providing an aluminum alloy having the composition Fe: 3-10; X: 3-10; Y: 0-1.5; Z: 0-10; wherein X represents an element or combination of elements (a) V and Si; (b) Cr and Ti; (c) Ce; or (d) Mn; each time with the proviso that the proportion of the individual elements in the combinations of elements (a) and (b) is at least 0.5 wt %; Y represents one or more grain-refining elements selected from the group of B, Ce, Sr, Sc, Mg, Nb, Mn and Zr, unless already present as X; Z represents one or more additives increasing the heat resistance, selected from the group of ceramic fibers, particles and platelets, the figures referring to % by weight in the alloy, and Al and production-related impurities representing the remaining proportion in the alloy to make 100 wt %, with the proviso that the proportion of Al in the alloy is at least 80 wt %; (ii) melting the aluminum alloy, dissolving and homogenizing the alloy elements at temperatures of from 650° C. to 1,000° C.; and (iii) casting the melt into a casting mold at a casting temperature ranging from the melting temperature of the alloy up to a temperature 150° C. above the melting temperature.

The invention relates to a higher-strength, cold-formable steel and to a steel sheet product produced from such a steel, in which an optimal combination of weldability and a low tendency toward delayed cracking as well as good strength and hot- and cold-formability are assured. In order to achieve this, a steel according to the invention contains (in % by weight) C: 0,1-1,0%, Mn: 10-25%, Si: up to 0.5%, Al: 0.3-2%, Cr: 1.5-3.5%, S: <0.03%, P: <0.08%, N: <0.1%, Mo: <2%, B: <0.01%, Ni: <8%, Cu: <5%, Ca: up to 0.015%, at least one element from the "V, Nb" group provided that: Nb: 0.01-0.5%, V: 0.01-0.5% and optionally Ti: 0.01-0.5%, and remainder being iron and unavoidable manufacturing-related impurities.

The invention discloses a method for synthesizing clindamycin phosphate, which comprises the following steps of: performing ketal protection reaction on clindamycin hydrochloride alcoholate at the temperature of between 2.0 below zero and 2.0 DEG C under the action of acetone and phosphorus oxychloride to form propylidene clindamycin; and performing esterification, hydrolysis, adsorption, washing, deabsorption, concentration, coarse crystallization, decoloration, refining and drying to obtain the finished product of clindamycin phosphate. Because a new catalyst 4-dimethylaminopyridine participates in the esterification in the rection system, the phosphorylating reaction is performed completely, and the conversion rate of raw materials is improved. Meanwhile, due to the secondary crystallization method, the problems of poor color grade and poor powder solubility are solved, and the operating conditions are mild and simple. By adopting triethylamine to replace partial pyridine, the esterification is pushed forwards; the reaction period is shortened; and importantly, related impurities in the finished product and the production cost are reduced, and the content is improved.

Capped poly(arylene ether)s are prepared by a method that includes reacting a poly(arylene ether) with a capping agent to form a capping reaction mixture, washing the capping reaction mixture with a concentrated basic aqueous solution, and isolating the capped poly(arylene ether) by a total isolation method. The washing method is effective for removal of capping-related impurities, and surprisingly does not result in decomposition of the capped poly(arylene ether).

The invention described herein provides new methods of preparing purified Factor VII polypeptide drug substances in large quantities (industrial scale levels) that are associated with reduced content of product-related impurities (e.g., late eluting peaks) and/or that exhibit a relatively uniform glycosylation pattern.

The invention provides an analytic method of an omeprazole related substance. The analytic method is characterized in that high performance liquid chromatography is adopted, an organic solvent and salt mixed phase is used for dissolving a sample, acetonitrile and phosphate with the pH of 7.6 are used as mobile phases, and the gradient elution is carried out on octyl bonds and a silica gel chromatographic column. The analytic method can be used for simply and effectively solving the defects of incapability of separating the rated substance and solvent peaks, little detection amount of impurities and the like and efficiently separating and identifying related impurities of the omeprazole.

The invention relates to a steel and a processing method for higher-strength fracture-splittable machine components that are composed of at least two fracture-splittable parts. Said steel and method are characterized in that the chemical composition of the steel (expressed in percent by weight) is as follows: C is between 0.40% and 0.60%; Si is between 0.20% and 1.00%; Mn is between 0.540% and 1.50%; Cr is between 0% and 1.00%; Ni is between 0% and 0.50%; Mo is between 0% and 0.20%; Nb is between 0% and 0.050%; V is between 0% and 0.30%; Al is between 0% and 0.05%; N is between 0.005% and 0.020%; the rest is composed of iron and smelting-related impurities and residual matter.

The invention relates, interalia, to the field of purification of peptides, notably cyclic or non-cyclic peptides their analogs or derivatives thereof. More particularly, the invention relates to a simplified and optimized purification process of cyclic peptides from a composition comprising the said peptide and at least one related impurity by chromatographic procedures enabling high yields, selectivity and purity of the desired end product. The improved process is particularly useful for the preparation of eptifibatide, exenatide, atosiban, nesiritide and their respective derivatives and analogs. The polypeptides are prepared in high purity of at least about 96%, and preferably at least about 99%.

An aluminium alloy having high mechanical strength and low quench sensitivity comprising 4.6 to 5.2 wt. % Zn, 2.6 to 3.0 wt. % Mg, 0.1 to 0.2 wt. % Cu, 0.05 to 0.2 wt. % Zr, max. 0.05 wt. % Mn, max. 0.05 wt. % Cr, max. 0.15 wt. % Fe, max. 0.15 wt. % Si, max. 0.10 wt. % Ti and aluminium as the remainder along with production related impurities, individually max. 0.05 wt. %, in total max. 0.15 wt. %. A process for producing plates having a thickness of more than 300 mm for manufacturing moulds for injection-moulding plastics is made up of the following steps: continuous casting the alloy into ingots having a thickness greater than 300 mm, heating the ingots to a temperature of 470 to 490° C. with a max. heating rate of 20° C./h between 170 and 410° C., homogenising the ingots for 10 to 14 h at a temperature of 470 to 490° C., cooling the ingots in still air to an intermediate temperature of 400-410° C., cooling the ingots by means of forced air cooling from the intermediate temperature of 400-410° C. to a temperature of less than 100° C., cooling the ingots to room temperature, artificially age-hardening the ingots at elevated temperature. The artificially age-hardened ingots can be employed for manu-facturing moulds for injection-moulding plastics.

The invention provides a method for determination of the content of a related impurity (5-methyl isoquinolinesulfonic acid) of fasudil hydrochloride. The method is characterized in that a reversed-phase high-performance liquid chromatographic peak area normalization method is adopted for quantitative analysis; for the chromatographic conditions, the chromatographic column is an ACCHROM XAmide column; the flow speed is 0.9-1.1ml/min; the detection wavelength is 238nm; the column temperature is 28-32 DEG C; the sample injection amount is 20mu l; a mobile phase A is 0.05mol/l ammonium dihydrogenphosphate aqueous solution; a mobile phase B is methanol; A:B is equal to (91-94): (6-9) (V:V). The method provided by the invention is convenient to control the product quality in the processes of production and quality control, and has the advantages of low cost, simpleness, easy implementation, high accuracy and precision, good stability and reproducibility and high sensitivity.

The invention provides a content determination method for fasudil hydrochloride related impurities, namely 5-isoquinoline sulfonic acid, pyridine N-oxyfasudil, 1-hydroxyfasudil, 8-quinoline fasudil, an 8-isomer, a piperazine condensation compound, N-hydroxyfasudil and a dimer. Quantitative analysis is performed by a reversed-phase high performance liquid chromatography peak area normalization method, and a chromatographic column with an octadecyl bonded phase as a stationary phase is used; the detection wavelength is 275nm; a mobile phase A is a phosphate buffer (pH of 6.95-7.05)-methanol (85:15), a mobile phase B is a phosphate buffer (pH of 6.95-7.05)-methanol (40:60), and gradient elution is performed. By the content determination method, product quality control during production and quality control is facilitated; the content determination method has the advantages of low cost, simplicity, easiness in implementation, high accuracy and precision and good stability and reproducibility.

The invention relates to a medicinal composition. The medicinal composition comprises sitagliptin, pharmaceutically acceptable salt thereof and/or hydrate of the salt, and anhydrous calcium hydrogen phosphate. The medicinal composition is further used for preparing a solid preparation, and is especially prepared into a tablet by a direct tabletting method. Through selection of the medicinal composition, especially selection of the specific anhydrous calcium hydrogen phosphate as a raw material, the quality control way of the medicinal composition using the sitagliptin, the pharmaceutically acceptable salt thereof and/or the hydrate of the salt as an active component can be significantly improved, and even production of related impurities in the medicinal composition can be significantly improved so as to improve the stability of the medicinal composition and relevant dosage forms.

A modular wastewater clarification device that may be positioned external to a septic tank or, alternatively, installed internally within a septic tank chamber to produce sufficiently clean water for lawn and agricultural uses. The modular clarification device includes a filter having a smaller size than the pre-filter bridging between the primary and secondary chambers of a septic tank. In one embodiment, the modular filtration unit resides outside the two-chambered septic tank and receives pre-filtered septic tank effluent fluids stored in the secondary chamber that has accumulated pre-filtered effluent. In another embodiment, the modular wastewater clarification device resides inside the secondary chamber and filters the accumulated pre-filtered effluent. The modular filtration device, having a substantially smaller pore size range than the inter-chamber pre-filter, releases clean water having substantially lowered bacterial and waster related impurities sufficient to meet water release standards suitable for lawn, garden, and agricultural uses.

The invention discloses a high-performance liquid chromatography separation and determination method for impurities in a fosfomycin trometamol raw material drug and preparations thereof and an application thereof, aiming at separating the impurities. According to the method, the aminopropyl silane-bonded silica gel is used as a chromatographic column of a filler, a differential detector is used for detection; and a phosphate buffer solution and methanol-acetonitrile are mixed as a mobile phase; the method includes the following steps of: 1, preparation of a system suitability solution: wettinga raw material drug or a preparation with water, heating, and dissolving and diluting the raw material drug or the preparation by the mobile phase to obtain a solution A; dissolving and diluting theraw material drug or the preparation by using the solution A to obtain the system suitability solution; 2, preparation of a test solution: taking the raw material drug or the preparation, and adding the mobile phase for dissolving and dilution to obtain the set content of fosfomycin trometamol as the test solution; 3, preparation of a reference solution: diluting the test solution by using the mobile phase to obtain a solution containing fosfomycin trometamol equivalent to a mass concentration of 0.3-0.5% of the test solution as the reference solution; and 4, determination method: separately injecting the above three solutions into a liquid chromatograph, and calculating the content of each impurity in the raw material drug by using a principal component self-control method.

The present invention relates to a purification salt conversion method of micafungin. According to the present invention, the method is mainly characterized in that a buffer solution of a corresponding salt and a micafungin N, N-diisopropylethylamine salt are subjected to ion exchange on a reverse phase preparative chromatographic column so as to complete salt conversion, remove the related impurities, and achieve the purification effect; and the process has characteristics of stable and controllable process, easy and convenient operation, easy industrial production achieving, and easy product quality control.