Q: Which countries are Agrifor reports used?

A: Agrifor reports are used Internationally including in jurisdictions of the USA and Brazil where specific report requirements are needed. We complete both non-GLP and GLP reports as required by clients. Companies are using Agrifor reports in EU countries, Australia, South Africa, USA, Brazil, Mexico, Argentina, China, Taiwan, Korea and many other countries. Our studies are fully compliant with OECD, EU, US EPA and SENASA requirements and can be submitted directly in support of registration anywhere in the world

Q: What is the typical lead time for the analysis and reports?

A: Depending on the chemistry, number of impurities and the reporting requirements the typical lead time is 3 months to complete. Screening and the main study takes around 4-6 weeks plus QA/QC and reporting another 4 weeks.

Q: Can you provide the raw data from your instruments including peak area?

A: It is important that we know the different countries that the reports will be used. Different countries require different report formats and often require additional data to be included. We provide “raw data” including peak areas for all peaks. We understand that a number of Authorities are now requesting such information to ensure that all peaks = / > 0.1% are identified and quantified in the report. We also provide raw data for spikes, impurities, active and LC/MS (area, retention time, area percent). Raw data is now included in every report. Raw data for all peaks >0.1% or for Raw data with peaks filtered > 0.05% can be accommodated. 3D data will be included in reports for Brazil and Mexico. Some consultants and Authorities now request that examples for all calculations presented in the reports is included. Agrifor provide calculation examples in every report. Note that certain charges may apply to the above supplementary data.

Q: Why is there no recovery test for active constituent?

A: Recovery tests are not possible for analysis of the active, and no regulatory authority is asking for it. This is because recovery test is done by spiking (adding) target compound (in this case active) into the sample solution. When active content is say 98% it is impossible to spike (add) another say 50%.

Q: LOD and LOQ are the same. Why?

A: For a Standard study (without impurity standards) we do limited method validation using a standard for the active only. In this case LOD = LOQ and it is determined by injecting the active standard at < LOQ.

Q: No mean and SD are provided for impurities, only for the active. Why?

A: The mean and %RSD are usually calculated for the active content and to evaluate sample Repeatability (from single batch, both for active and impurities). It has a purpose to calculate the mean and %RSD for A.I. content where concentration is high (usually more then 95%), to show consistency and quality of manufacturing process. However, for impurities content such calculation is meaningless because it does not show anything about consistency and quality of manufacturing process ( for example, concentrations of one impurity can vary from 1.0 g/kg to 3.0 g/kg in the test sample and %RSD will be 20 or 30%). We can add the SD but it may look significant and you may have need to answer questions from Authorities regarding the variation in impurity levels and control of impurity levels.

Q: Rounding of Numbers / Significant numbers.

A: In science, all numbers are based upon measurements (except for a very few that are defined). Since all measurements are uncertain, we must only use those numbers that are meaningful. A common ruler cannot measure something to be 22.4072643 cm long. Not all of the digits have meaning (significance) and, therefore, should not be written down. In science, only the numbers that have significance (derived from measurement) are written. We use Excel spreadsheet to calculate all the results in the study. Once we do the calculations, the results usually show numbers with many, sometimes infinite decimal places. It is clear that we can not put a number with 10 decimal places in the report. This is because we have to follow well known scientific rules for presentation of results using significant figures. As an example if the actual concentration of a Standard is 60.89823912, it will be shown in the report as 60.9. This is because the final result can not be more accurate than the least accurate measurement. We recorded the weight of standard used to make standard solutions as say 10.3 mg, which is in accordance to capability of our balance (Analytical balance capable of weighing to ±0.1 mg). So the concentration of the standard solution (say 60.9) can not have more decimal places than the number of decimal places we recorded for the standard (10.3). When measurements are multiplied or divided, the answer can contain no more significant figures than the least accurate measurement.

Q: What is the best method for testing the Active constituent?

A: The Active can be tested by any method and it is very easy to do. Impurities however are much more complicated and the best and most suitable method (most specific method) should be used. For the active where the Client method causes issues with degradation and / or isomerisation, Agrifor will develop and validate an appropriate method.

Q: Can you assist to supply Impurity standards if required?

A: Yes, we regularly work with the client to provide all standards. For the impurity standards we work in cooperation to ensure standards are obtained cost effectively; 1) Agrifor will check if impurity standards can be purchased from commercial suppliers, and invoice at cost. 2) If impurity standards are not available from commercial suppliers and if Agrifor already has one or more impurity standards prepared earlier, the cost for such standard would be AUS $1,650 per standard. 3) If Agrifor does not already have impurity standards, Agrifor will attempt to extract them from samples and certify as standards. 4) If impurity standards can not be prepared by extraction from the technical material due to solubility or other reasons, Agrifor will, in agreement, contract a custom synthesis of impurity standards

Q: There are unidentified peaks in the chromatograms of the samples. Please clarify why these peaks were not identified.

A: Only peaks at a level > 0.1% are identified and quantified. Our studies are fully compliant with OECD, EU, US EPA and SENASA requirements and can be submitted directly in support of registration anywhere in the world.

Q: There are no CAS numbers allocated to the impurities identified. Why?

A: Not all impurities will have a CAS numbers allocated. These impurities may be newly discovered or not currently recorded on the CAS database. Where CAS numbers are available they are included in the reports however AgriFor does not send chemical information to Chemical Abstract Services for updating the CAS database.

Q: Are CoA’s for significant and toxic impurities available?

A: CoA’s will be included in the Report for actives, significant and toxic impurities. The CoA will be provided by the manufacturer or supplier of the material. In the case Agrifor validates a standard, the CoA will be issued by Agrifor.

Q: Is Agrifor able to organise Legalisation of documents such as CoA?

A: Yes, legalisation is done regularly and typically involves a Public notary, the Australian Department of Foreign Affairs and Trade, and the relevant local Trade Consulate. Typical time to process documents is around 4-6 weeks. Charges apply.