USP <621> Chromatography HPLC Proficiency Test for Liquids
Proficiency Test for laboratories performing testing in accordance with USP <621> using High Pressure Liquid Chromatography HPLC on liquid pharmaceutical materials.
Choose Study: PH-0921, PH-0122, PH-0422
Qualitative and Quantitative Proficiency Test (PT) for laboratories performing HPLC Assay of liquid material by USP <621> or equivalent. Participants may report qualitative and/or quantitative results for their liquid material sample(s). Samples provided as a three sample panel. One of three samples will be positive for target analyte. Participants are asked to identify the positive sample by HPLC peak retention time match (ID Test). Determine the concentration (Assay) in percentage (%) of target analyte in the liquid sample per the USP monograph or equivalent.
Positive Sample: Caffeine Citrate Liquid Solution
Negative Samples: Citric Acid Liquid Solution
Caffeine (powdered solid) Reference Material Standard will be provided with the Proficiency Test Samples
USP <621> Chromatography HPLC Proficiency Test for Solid Materials
Proficiency Test for laboratories performing testing of solid pharmaceutical material using High Pressure Liquid Chromatography, HPLC, in accordance with USP 621.
Choose Study: PH-0921, PH-0122, PH-0422
Qualitative and Quantitative Proficiency Test (PT) for laboratories performing HPLC Assay of solid materials by USP <621> or equivalent. Participants may report qualitative and/or quantitative results for their powder sample(s). Samples provided as a three sample panel. One of three samples will be positive for target analyte. Participants are asked to identify the positive sample by HPLC peak retention time match (ID Test). Determine the concentration (Assay) in percentage (%) of target analyte in the solid sample per the USP monograph or equivalent.
Positive Sample: Maltitol, powdered or granulated solid
Negative Samples: Sorbitol, powdered or granulated solid
Maltitol Reference Material Standard will be provided with the Proficiency Test Samples
USP <621> Chromatography GC-FID Proficiency Test
Proficiency Test for laboratories performing Assay by USP <621> GC-FID Chromatography with corresponding identification by retention time match.
Choose Study: PH-0921, PH-0122, PH-0422
Qualitative and Quantitative Proficiency Test (PT) for laboratories performing GC-FID Chromatography Assay by USP <621> or equivalent. Participants may report qualitative and/or quantitative results for their sample(s). Samples provided as a three sample panel. One of three samples will be positive for target analyte. Participants are asked to identify the positive sample peak retention time match (ID Test). Determine the concentration (Assay) in percentage (%) of target analyte in the sample per the USP monograph or equivalent.
Positive Sample: Isopropyl alcohol
Negative Samples: Isobutanol
2-Propanol Reference Material Standard will be provided with the Proficiency Test Samples
USP <541> Potentiometric Titration Proficiency Test
Proficiency Test for laboratories performing Assay by USP <541> Potentiometric Titration.
Choose Study: PH-0921, PH-0122, PH-0422
Quantitative Proficiency Test (PT) for laboratories performing Potentiometric Titriation Assay by USP <541> or equivalent. Participants report quantitative results for their sample(s). Samples provided two vials containing 500mg of material. Participants are asked to determine the concentration (Assay) in percentage (%) of target analyte in the sample per the USP monograph or equivalent.
Target Analyte: Sodium Chloride, powdered or granulated solid
USP <541> Colorimetric Titration Proficiency Test
Proficiency Test for laboratories performing Assay by USP <541> Colorimetric Titration.
Choose Study: PH-0921, PH-0122, PH-0422
Quantitative Proficiency Test (PT) for laboratories performing Colorimetric Titration Assay by USP <541> or equivalent. Participants report quantitative results for their sample(s). Samples provided two vials containing 500mg of material. Participants are asked to determine the concentration in percentage (%) of target analyte in the sample per the USP monograph or equivalent.
Target Analyte: Calcium Ascorbate, powdered or granulated solid
USP <644> Conductivity Proficiency Test
Proficiency Test for laboratories performing USP 644 Conductivity testing on pharmaceutical materials by measuring voltage in milli siemens.
Choose Study: PH-0921, PH-0122, PH-0422
Quantitative Proficiency Test (PT) for laboratories performing Conductivity by USP <644> or equivalent. Participants report quantitative results for conductivity, testing for material’s conductivity in micro siemens per centimeter (uS/cm), for their sample(s). Samples provided two vials containing 10g of material. Participants are asked to determine the conductivity of target analyte in the sample per the USP monograph or equivalent.
Target Analyte: Erythriol, powdered or granulated solid
USP <281> Residue on Ignition Proficiency Test
Proficiency Test for laboratories performing Assay by USP <281> Residue on Ignition.
Choose Study: PH-0921, PH-0122, PH-0422
Quantitative Proficiency Test (PT) for laboratories performing Residue on Ignition Assay by USP <281> or equivalent. Participants report quantitative results for their sample(s). Samples provided two vials containing 2g of material. Participants are asked to determine the percentage (%) of Residue on Ignition (Assay) of target analyte in the sample per the USP monograph or equivalent.
Target Analyte: Corn Starch, powder solid
USP <905> Uniformity of Dosage Proficiency Test
Proficiency Test for laboratories performing Assay by USP <905> Uniformity of Dosage.
Choose Study: PH-0921, PH-0122, PH-0422
Quantitative Proficiency Test (PT) for laboratories performing Uniformity of Dosage Assay by USP <905> or equivalent. Participants report quantitative results for their sample(s). Samples provided as 1 bottle containing 30 tablets of material. One bottle of 30 tablets supplied per order. Participants are asked to quantitatively determine the uniformity of the amount for the target analyte in the tablet sample per the USP monograph or equivalent.
Target Analyte: Acetaminophen per tablet
USP <791> pH Proficiency Test
Proficiency Test for laboratories performing pH testing, potential hydrogen ions, of pharmaceutical material by USP <791>.
Choose Study: PH-0921, PH-0122, PH-0422
Quantitative Proficiency Test (PT) for laboratories performing potential hydrogen ions, pH, testing by USP <791> or equivalent. Participants report quantitative results for their sample(s). Samples provided two vials containing 6g of material. Participants are asked to determine the pH of the sample per the USP monograph or equivalent.
Target Analyte: Corn Starch, powder solid
USP <197U> Proficiency Test for Identification by UV/Visible Spectroscopy
Proficiency Test for laboratories performing Assay by USP <197U> UV/Visible Spectroscopy
Choose Study: PH-0921, PH-0122, PH-0422
Qualitative Proficiency Test (PT) for laboratories performing UV/Visible Spectroscopy by USP <197U> or equivalent. Participants report qualitative results for their samples. Samples provided as a three sample panel. One of three samples will be positive for target analyte. Participants are asked to identify the positive sample by UV/Vis ID test per USP monograph.
Positive Sample: Acetaminophen, powdered or granulated solid
Negative Samples: Caffeine, powdered or granulated solid
Sorbic Acid Reference Material Standard will be provided with the Proficiency Test Samples
USP <921> Water Determination Proficiency Test
Proficiency Test for laboratories performing Water Determination (%) testing of a liquid pharmaceutical material by USP <921>.
Choose Study: PH-0921, PH-0122, PH-0422
Quantitative Proficiency Test (PT) for laboratories performing Water Determination testing by USP <921> or equivalent. Participants report quantitative results for their liquid sample(s). Samples provided two vials containing 10mL of material. Participants are asked to determine the percent (%) water content in a liquid pharmaceutical product sample per the USP monograph or equivalent.
Sample Material: Isopropyl Alcohol, between 60-99% (w/w)
USP <921> Water Determination Proficiency Test for Solid Materials
Proficiency Test for laboratories performing Water Determination (%) testing of a solid pharmaceutical material by USP <921>.
Choose Study: PH-0921, PH-0122, PH-0422
Quantitative Proficiency Test (PT) for laboratories performing Water Determination testing by USP <921> or equivalent. Participants report quantitative results for their solid sample(s). Samples provided two vials containing 5g of material. Participants are asked to determine the percent (%) water in a solid pharmaceutical product sample per the USP monograph or equivalent.
Sample Material: Lactose Anhydrous (powder)
USP <731> Loss on Drying Proficiency Test
Proficiency Test for laboratories performing Loss on Drying testing of a pharmaceutical material by USP <731>.
Choose Study: PH-0921, PH-0122, PH-0422
Quantitative Proficiency Test (PT) for laboratories performing Loss on Drying testing by USP <731> or equivalent. Participants report quantitative results for their sample(s). Samples provided in duplicate. Participant will receive two vials containing 2g of material. Participants are asked to determine the percent (%) loss on drying for the sample per the USP monograph or equivalent.
Sample Material: Corn Starch, powdered solid
USP <831> Proficiency Test for Refractive Index
Proficiency Test for laboratories performing Refractive Index testing by USP <831>
Choose Study: PH-0921, PH-0122, PH-0422
Qualitative Proficiency Test (PT) for laboratories performing Refractive Index tests by USP <831> or equivalent. Participants report qualitative results for their samples. Samples provided as a three sample panel. One of three samples will be positive for target analyte. Participants are asked to identify the positive sample by Refractive Index ID test per USP monograph.
Positive Sample: Isopropyl Alcohol, 1.5mL
Negative Samples: 1-Propanol, 1.5mL
Isopropyl Alcohol Reference Material Standard will be provided with the Proficiency Test Samples
USP <62> Microbiological Examination of Non-Sterile Products Proficiency Test
Proficiency Test for laboratories testing specified microorganisms in non-sterile products by USP <62>.
Choose Study Number: PH-0921, PH-0122, PH-0422
Qualitative Proficiency Test (PT) for Specified Microorganisms in Non-Sterile Products by USP <62> or equivalent. Samples are provided as a panel of five single-pellet vials plus five vials of lactose monohydrate. Each vial of lactose monohydrate contains 10 grams per vial. Participants will follow provided step-by-step instructions to prepare each sample for plating onto suitable microbiological media. Participants may report qualitative results of either present or absent for their samples. Three of the five samples will contain microorganisms and therefore be positive. Participants are asked to identify a positive sample by indicating present and identify a negative sample by indicating absent.
A positive sample will contain one of the following microorganism species:
Staphylococcus aureus, Salmonella enterica abony, Salmonella enterica typhi, Escherichia coli, Candida albicans
A negative sample will be sterile and not contain any microorganisms.
USP <467> Proficiency Test for Residual Solvents in Solid Pharmaceutical Materials
Proficiency Test for laboratories testing residual solvents in pharmaceutical solid materials by USP <467>, or equivalent.
Choose Study: PH-0921, PH-0122, PH-0422
Qualitative and Quantitative Proficiency Test (PT) for laboratories performing residual solvent testing of solid materials by USP <467> or equivalent. Participants may report qualitative and/or quantitative results for their sample(s). Sample provided in duplicate for value and convenience. Therefore, participant will receive 2 vials of 10g Lactose Monohydrate and 6 ampules of 1.5mL residual solvent mixture spiking solution, 2 ampules per class of residual solvents. Participants are asked to identify the residual solvents present in the sample mixture per the USP monograph or equivalent.
USP <467> Proficiency Test for Residual Solvents in Liquid Pharmaceutical Materials
Proficiency Test for laboratories testing residual solvents in liquid pharmaceutical materials by USP <467>, or equivalent
Choose Study: PH-0921, PH-0122, PH-0422
Qualitative and Quantitative Proficiency Test (PT) for laboratories performing residual solvent testing of liquid materials by USP <467> or equivalent. Participants may report qualitative and/or quantitative results for their sample(s). Sample provided in duplicate for value and convenience. Therefore, participant will receive 6 ampules of 1.5mL residual solvent mixture spiking solution, 2 ampules per class of residual solvents. Participants are asked to identify the residual solvents present in the sample mixture per the USP monograph or equivalent.
USP <781> Proficiency Test for Optical Rotation
Proficiency Test for laboratories performing Optical Rotation by USP <781>
Choose Study: PH-0921, PH-0122, PH-0422
Qualitative Proficiency Test (PT) for laboratories performing Optical Rotation testing by USP <781> or equivalent. Participants report qualitative results for their samples. Participants are asked to indicate presence or absence for the target analyte when reporting results for each sample. Samples provided as a three sample panel. One of three samples will be positive for the target analyte. Participants are asked to identify the positive sample by Optical Rotation ID test per USP monograph.
Positive Sample: Calcium Ascorbate, powdered or granulated solid
Negative Samples: Sodium Ascorbate, powdered or granulated solid
Calcium Ascorbate Reference Material Standard will be provided with the Proficiency Test Samples
USP <233> Elemental Impurities Proficiency Test
Proficiency Test for laboratories performing Assay by USP <233> Elemental Impurities.
Choose Study: PH-0921, PH-0122, PH-0422
Quantitative Proficiency Test (PT) for laboratories performing Elemental Impurities Assay by USP <233> or equivalent. Participants report quantitative results for their sample(s). Samples provided two vials containing 5 grams Calcium Succinate Monohydrate fortified with elemental impurities at varying concentrations. Participants are asked to quantitatively determine the amount for each elemental impurity in the sample per the USP monograph or equivalent.
Elemental Impurities:
Cadmium 10-100ug/g
Lead 10-100ug/g
Arsenic 15-150ug/g
Mercury 30-300ug/g
USP <621> Chromatography UPLC Proficiency Test
Proficiency Test for laboratories performing Assay by USP <621> Ultra High Pressure Liquid Chromatography UPLC.
Choose Study: PH-0921, PH-0122, PH-0422
Qualitative and Quantitative Proficiency Test (PT) for laboratories performing Ultra High Pressure Liquid Chromatography UPLC by USP <621> or equivalent. Participants may report qualitative and/or quantitative results for their sample(s). Samples provided as a three sample panel. One of three samples will be positive for target analyte. Participants are asked to identify the positive sample by UPLC peak retention time match (ID Test). Determine the concentration (Assay) in percentage (%) of target analyte in the sample solution per the USP monograph or equivalent.
Positive Sample: Acetaminophen, powdered solid
Negative Samples: Ibuprofen, powdered solid
Acetaminophen (powdered solid) Reference Material Standard will be provided with the Proficiency Test Samples
USP <71> – Sterility Proficiency Test
Choose Study Number
PH-0921, PH-0122, PH-0422
Proficiency Test for laboratories testing pharmaceutical materials for the presence or absence of specified microorganisms in accordance with USP 71. A five vial sample panel with three POSITIVE (non-sterile) and two NEGATIVE (sterile) containing organisms of interest at appropriate levels for USP <71>. The panel contains five single-pellet vials, three positive sample pellets containing Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, Candida albicans, or Aspergillus brasiliensis. as well as Two blank pellets. The panel also includes five 5mL vials of sterile peptone buffer. Participants will identify which samples meet the sterility test requirements per the USP monograph.
USP <61> Microbial Enumeration of Non-Sterile Products Proficiency Test
Choose Study Number
PH-0921, PH-0122, PH-0422
Quantitative Proficiency Test (PT) for Specified Microorganisms in Non-Sterile Products by USP <61> or equivalent. Samples are provided as two single-pellet vials plus two vials of lactose monohydrate. Each vial of lactose monohydrate contains 10 grams per vial. Participants will follow provided step-by-step instructions to prepare each sample for plating onto suitable microbiological media. Participants will then quantify the microorganism present in the sample.
The positive microorganism may be any of the following species Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, Candida albicans, or Aspergillus brasiliensis.
USP <197> Proficiency Test for Identification by FTIR Spectroscopy
Proficiency Test for laboratories performing Assay by USP <197> Fourier Transform Infrared FTIR Spectroscopy
Choose Study
PH-0921, PH-0122, PH-0422
Qualitative Proficiency Test (PT) for laboratories performing Fourier Transform Infrared FTIR Spectroscopy by USP <197> or equivalent. Participants report qualitative results for their samples. Samples provided as a three sample panel. One of three samples will be positive for target analyte. Participants are asked to identify the positive sample by FTIR ID test per USP monograph.
Positive Sample: Lactose Monohydrate, powdered or granulated solid
Negative Samples: Maltose, powdered or granulated solid
Lactose Monohydrate Reference Material Standard will be provided with the Proficiency Test Samples
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