CIPAC. CIPAC Free relevant impurities methods:

Similar documents
637. Thiamethoxam. HPLC method

H 3 CO H 3 CO S CH 3

PYRIPROXYFEN TECHNICAL

TECHNICAL TEMEPHOS. 1. Specification. Full specification WHO/SIT/19.R4 Revised 10 December Description

TECHNICAL BRODIFACOUM

INSTRUCTIONS FOR WRITING CIPAC METHODS

TEMPLATE FOR AN EXAMPLE STANDARD TEST METHOD

IDENTIFICATION AND DETERMINATION OF HYDROQUINONE IN COSMETIC PRODUCTS 2 14/11/17 ACM 003 BY TLC AND HPLC

Quantitative determination of ethephon in soluble concentration (SL) by Ion chromatography

ARTEMETHER AND LUMEFANTRINE TABLETS: Final text for addition to The International Pharmacopoeia (July 2008)

VALIDATION OF A UPLC METHOD FOR A BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE TOPICAL SOLUTION

The analysis of organic acid content of additives, premix, feed, and water.

ADVANTAME. Not less than 97.0% and not more than 102.0% on the anhydrous basis. Sweetener, flavour enhancer

RESOLUTION OENO 33/2004 DETERMINATION OF SHIKIMIC ACID IN WINE BY HPLC AND UV-DETECTION

LUMEFANTRINUM LUMEFANTRINE

ARTEMETHER AND LUMEFANTRINE ORAL SUSPENSION:Final text for addition to The International Pharmacopoeia (November 2008)

ANALYTICAL METHOD PROCEDURES

Determination of Caffeine by HPLC

DETERMINATION OF DRUG RELEASE DURING DISSOLUTION OF NICORANDIL IN TABLET DOSAGE FORM BY USING REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

METHOD 8033 ACETONITRILE BY GAS CHROMATOGRAPHY WITH NITROGEN-PHOSPHORUS DETECTION

AMISULBROM (No.789) CIPAC Collaborative Trial

DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR THE ESTIMATION OF NICERGOLINE IN MARKETED FORMULATIONS

ADVANTAME (TENTATIVE)

EFAVIRENZ Final text for addition to The International Pharmacopoeia

Technical Procedure for Concentration Determination of Methamphetamine in Liquids via HPLC

OMCL Network of the Council of Europe QUALITY MANAGEMENT DOCUMENT

Draft Method proposal: determination of glucoheptonic acid (HGA) in fertilizers.

Revision Bulletin 27 Jan Feb 2017 Non-Botanical Dietary Supplements Compliance

Volume 6, Issue 2, January February 2011; Article-015

Ondansetron Hydrochloride Tablets

Sulfotepp impurities in Chlorpyrifos EC formulations

Quantification of growth promoters olaquindox and carbadox in animal feedstuff with the Agilent 1260 Infinity Binary LC system with UV detection

Revision Bulletin 29 Dec Jan 2018 Non-Botanical Dietary Supplements Compliance

GUIDELINES FOR THE DESIGN OF CHROMATOGRAPHIC ANALYTICAL METHODS INTENDED FOR CIPAC COLLABORATIVE STUDY

NEVIRAPINE ORAL SUSPENSION Final text for addition to The International Pharmacopoeia (February 2009)

Final Report. Characterisation of Sample Report. Job No 2016/11/12-34 AS No. 1234A. Client Example Contact Sample. Signed Date 2017.

Fast methods for the determination of ibuprofen in drug products

The Nitrofurantoin Capsules Revision Bulletin supersedes the currently official monograph.

CYCLOSERINE Final text for addition to The International Pharmacopoeia. (November 2008) CYCLOSERINUM CYCLOSERINE

STABILITY INDICATING METHOD OF RELATED IMPURITIES IN VENLAFAXINE HYDROCHLORIDE SUSTAINED RELEASE TABLETS

Development and Validation of a HPLC Method for Chlorphenamine Maleate Related Substances in Multicomponents Syrups and Tablets

Determination of Polymer Modifier in Asphalt

Cyanide and sulfide analysis using amperometric detection and Metrosep A Supp /4.0

7. Stability indicating analytical method development and validation of Ramipril and Amlodipine in capsule dosage form by HPLC.

GB Translated English of Chinese Standard: GB NATIONAL STANDARD OF

contents of the currently official monograph. Please refer to the current edition of the USP NF for official text.

Chemistry 3200 High Performance Liquid Chromatography: Quantitative Determination of Headache Tablets

This method describes the identification of the following prohibited colorants in cosmetic products:

ANALYTICAL METHOD DETERMINATION OF VOLATILE ALDEHYDES IN AMBIENT AIR Page 1 of 11 Air sampling and analysis

Liquid storage: Holds the solvent which is going to act as the mobile phase. Pump: Pushes the solvent through to the column at high pressure.

IDENTIFICATION OF STEROIDS IN COSMETIC PRODUCTS BY TLC AND HPLC 1 02/12/2005 ACM 007 A. THIN LAYER CHROMATOGRAPHY (TLC)

Validated RP-HPLC Method for Estimation of Cefprozil in Tablet Dosage Form

INDIGOTINE. Disodium 3,3'-dioxo-[delta 2,2' -biindoline]-5,5'-disulfonate (principal component) (principal component)

Should you have any questions, please contact Mary P. Koleck, Ph.D., Scientific Liaison ( or

HPLC Praktikum Skript

Method Development and Validation Of Prasugrel Tablets By RP- HPLC

A RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF PARA- PHENYLENEDIAMINE IN PURE FORM AND IN MARKETED PRODUCTS

METHOTREXATE mg/m 3 (arbitrary). There is no OSHA PEL or AGGIH TLV for

Chapter 4: Verification of compendial methods

Dilution(*) Chromatography

Additionally, minor editorial changes have been made to update the monograph to current USP style.

Analytical method related to authorised feed additive - 1i534

Automated Sample Preparation in Quality Control of Eye-Drop Formulation

Determination of Trace Cations in Power Plant Waters Containing Morpholine

TECHNICAL DIAZINON. 1. Specification. Full specification WHO/SIT/9.R7 Revised 10 December Description

--> Buy True-PDF --> Auto-delivered in 0~10 minutes. GB Translated English of Chinese Standard: GB5009.

Development and Validation of Stability-Indicating RP-HPLC Method for Estimation of Atovaquone

Diquat 1,1 -ethylene-2,2 -bipyridium dibromide salt Paraquat 1,1 -dimethyl-4,4 -bipyridium dichloride salt Initial Preparation

Determination of Total Bromine and Iodine Emission Spectrometric Method (ICP-OES) EuSalt/AS

Analysis of DNPH-derivatized Aldehydes and Ketones using the Agilent 1220 Infinity LC System with Diode Array Detector

Simultaneous HPLC Determination of Methocarbamol, Paracetamol and Diclofenac Sodium

METHOD 8030A ACROLEIN AND ACRYLONITRILE BY GAS CHROMATOGRAPHY

Chemistry Gas Chromatography: Separation of Volatile Organics

Pelagia Research Library

Anethole. Gas chromatograhpy determination of trans-anethole in Spirit srinks of viti-vinicultural origin

USP Method Transfer and Routine Use Analysis of Irbesartan Tablets from HPLC to UPLC

Revision Bulletin Official April 1, 2014 Alprazolam 1

DETERMINATION OF BIOPHENOLS IN OLIVE OILS BY HPLC

Method for the determination of 1,3-butadiene

Development and validation a RP-HPLC method: Application for the quantitative determination of quetiapine fumarate from marketed bulk tablets

British American Tobacco Group Research & Development. Method - Determination of ammonia in mainstream smoke

Chromatographic Analysis

TERTIARY BUTYLHYDROQUINONE

INTERNATIONAL JOURNAL OF RESEARCH IN PHARMACY AND LIFE SCIENCES

Application Note. Authors. Abstract. Energy & Chemicals, Biofuels & Alternative Energy

Stability-indicating HPLC determination of tolterodine tartrate in pharmaceutical dosage form

METHOD: 1403, Issue 3 EVALUATION: FULL Issue 1: 15 August 1990 Issue 3: 15 March 2003

DISCLAIMER: This method:

BRIEFING. (EXC: K. Moore.) RTS C Propylparaben C 10 H 12 O Benzoic acid, 4 hydroxy, propyl ester; Propyl p hydroxybenzoate [ ].

USP 36 Official Monographs / Metformin carding the first 3 ml of filtrate. Transfer 25 ml of the Analysis

Determination of Polyacrylic Acid in Boiler Water Using Size-Exclusion Chromatography with Charged Aerosol Detection

Method Development and Validation for the Estimation of Darunavir in Rat Plasma by RP-HPLC

Simultaneous Estimation of Residual Solvents (Isopropyl Alcohol and Dichloromethane) in Dosage Form by GC-HS-FID

POLYDEXTROSES. SYNONYMS Modified polydextroses; INS No DEFINITION DESCRIPTION. FUNCTIONAL USES Bulking agent, humectant, stabilizer, thickener

Analytical Method Development and Validation of Lafutidine in Tablet dosage form by RP-HPLC

Anion and Cation analysis with Professional IC - automatic dilution and sample preparation with SPM

Relative Response Factor for Lamivudine and Zidovudine Related substances by RP-HPLC with DAD detection

USP 35 Official Monographs / Oxaliplatin 4143 DEFINITION

Radhakrishnan K. et al. / International Journal of Pharmacy & Therapeutics, 3(1), 2012, e- ISSN Print ISSN

Int. J. Pharm. Sci. Rev. Res., 30(2), January February 2015; Article No. 09, Pages: 63-68

Transcription:

CIPAC COLLABORATIVE INTERNATIONAL PESTICIDES ANALYTICAL COUNCIL LIMITED Commission Internationale des Méthodes d'analyse des Pesticides (CIMAP) CIPAC Free relevant impurities methods: Methods for relevant impurities becoming more and more important in the quality control of TK/TC and FAO-specifications. In order to meet an urgent need for methods to characterize TK/TC in a.i. and formulations, CIPAC provides selected methods as download. By downloading these methods, you accept the following conditions of use. Terms of Use: these methods are provided subject to changes without prior notice the copyright of these methods is with CIPAC CIPAC declines any responsibility when using these methods 1

TRANSFLUTHRIN PAA Impurity, 1R-trans-permethric acid anhydride Report Name 1R-trans-permethric acid anhydride Chemical name (1R,3S)-3-(2,2-dichlorovinyl)-2,2- dimethylcyclopropanecarboxylic anhydride (IUPAC) cyclopropanecarboxylic acid, 3-(2,2- dichloroethenyl)-2,2-dimethyl-, 1,1 - anhydride, (1R,1 R,3S,3 S)- (CA; Registry 1664359-57-2) Structural formula Empirical Formula C16H18Cl4O3 RMM 400.1 2

TRANSFLUTHRIN 741 See CIPAC K, page 121 TRANSFLUTHRIN TECHNICAL * 741/TC/M/- 1 Sampling. Take at least 25 g. Do not heat the sample to liquefy; mechanically homogenize solidified samples instead. Use samples which are liquid at room temperature as such. 2 Identity tests. 2.1 HPLC. Use the HPLC method described below. The relative retention time of 1R-trans permethric acid anhydride in the sample solution should not deviate by more than 4 % from that of the calibration solution. 2.2 UV spectroscopy. Record the UV spectrum during the HPLC determination. The UV spectrum obtained from the sample and reference item should not differ significantly. (Fig. 1) 4 1R-trans permethric acid anhydride. OUTLINE OF THE METHOD. 1R-trans permethric acid anhydride contents are determined (ppm) by reversed phase high performance liquid chromatography using UV detection at 210 nm and external standard calibration. * CIPAC method 2018. Based on a method supplied by Bayer Crop Science, Germany 3

REAGENTS AND EQUIPMENT 1R-trans permethric acid anhydride reference standard of known content Acetonitrile (HPLC grade) Phosphoric acid (HPLC grade, 85 90 %) Purified water (HPLC grade) Eluent A: phosphoric acid 0.01 mol/l Eluent B: acetonitrile APPARATUS New generation high performance liquid chromatograph equipped with an injection system and a sensitive UV spectrophotometric detector operating at 210 nm. Liquid chromatography column, stainless steel, 100 x 4.6 (i.d.) mm, packed with Zorbax SB C8, 1.8 µm or equivalent with the same selectivity. Electronic integrator or data system. Ultrasonic bath. Polypropylene injection vials PROCEDURE (a) Operating conditions (typical): Flow rate: 2.0 ml/min Column temperature: 70 C Injection volume: 3 µl Detector wavelength: 210 nm Gradient: time (min) % A % B 0.0 40 60 2.0 40 60 8.0 5 95 8.1 0 100 12.0 0 100 12.1 40 60 14.0 40 60 4

Retention time: Total run time: approx. 4.6 min for 1R-trans permethric acid anhydride approx. 14 min (b) Equilibration of the system. Pump sufficient mobile phase through the column to equilibrate the system. Inject 3 µl portions of the calibration solution C1 and repeat the injections until retention times and peak areas deviate by less than ± 1 % from the mean for three successive injections. (c) Calibration solution. Ensure temperature equilibration for all dilution steps. Weigh (to the nearest 0.1 mg) approximately 10 mg of the reference item into a volumetric flask (100 ml). Add 20 ml of acetonitrile and place the flask in an ultrasonic bath for 5 minutes. Make up to volume with acetonitrile. Transfer 1 ml of this solution into a separate volumetric flask (100 ml) and make up to volume with acetonitrile (Calibration solution C1). (Fig. 2) (d) Sample preparation. Ensure temperature equilibration for all dilution steps. Prepare sample solutions in duplicate for each sample. Weigh (to the nearest 0.1 mg) 100 mg of Transfluthrin into a volumetric flask (10 ml). Add 5 ml acetonitrile and place the flasks in an ultrasonic bath for 5 min. Make up to the mark with acetonitrile (Sample solutions S1, S2). (spiked sample solution Fig. 3) (e) Determination. Inject in duplicate each calibration and sample solution and bracket a series of sample solution injections by injections of the calibration solution as follows: calibration solution, sample solution, calibration solution, (C1, S1, S2, C1, ). Do not use the calibration solution vials for more than two consecutive injections. Prepare fresh fillings from the stock solution instead. Determine the peak areas of 1R-trans-permethric acid anhydride. 5

(f) Calculation. Calculate the response factors from the calibration solution bracketing the injections of the sample solutions. Average the response factors of the calibration solutions preceding and following the sample solution injections. These must agree within ± 2 % of the average otherwise repeat the determination. Calculate the content of the sample solutions. f " = s P H ) Where: content = H / f w f " = single response factor f = average response factor H ) = peak area of 1R-trans-permethric acid anhydride standard in the calibration solution H / = peak area of 1R-trans-permethric acid anhydride in the sample solution s = weight of the 1R-trans-permethric acid anhydride standard in the calibration solution (mg/10 ml) w = weight of the sample (mg/10 ml) P = purity of the 1R-trans-permethric acid anhydride standard (g/kg) Fig. 1 UV-Spectrum of 1R-trans-permethric acid anhydride 6

Fig. 2 Chromatogram of 1R-trans-permethric acid anhydride analytical standard Fig. 3 Chromatogram of a spiked technical Transfluthrin batch (Content of 1Rtrans-permethric acid anhydride of approx. 70 ppm) 7