chromogenic assay intended for the quantitative determination in purified solutions by measurement of factor IIa or Xa inhibition activity. The kit can be used for 100 test reactions as per microtiter plate protocol.
Validation of factor xa assay for nadroparin calcium nadroparin injectionkrishgen
This document describes a chromogenic assay used to quantify the anticoagulant Nadroparin in samples by measuring its inhibitory effect on factor Xa. The assay involves incubating Nadroparin samples with factor Xa and anti-thrombin III, then adding a chromogenic substrate and measuring the absorbance. The absorbance is inversely proportional to the Nadroparin concentration as it inhibits factor Xa activity. The assay kit and procedure are validated for use in quantifying Nadroparin levels in bioequivalence studies.
Validation of factor i ia assay for tinzaparin sodium-tinzaparin injectionkrishgen
chromogenic assay intended for the quantitative determination in purified solutions by measurement of factor IIa or Xa inhibition activity. The kit can be used for 100 test reactions as per microtiter plate protocol.
Validation of factor xa assay for dalteparin sodium dalteparin injectionkrishgen
chromogenic assay intended for the quantitative determination in purified solutions by measurement of factor IIa or Xa inhibition activity. The kit can be used for 100 test reactions as per microtiter plate protocol.
Validation of factor xa assay for enoxaparin sodium enoxaparin injectionkrishgen
chromogenic assay intended for the quantitative determination in purified solutions by measurement of factor IIa or Xa inhibition activity. The kit can be used for 100 test reactions as per microtiter plate protocol.
Validation of Factor IIa assay for enoxaparin sodium or enoxaparin injectionkrishgen
A chromogenic assay intended for the quantitative determination in purified solutions by measurement of factor IIa or Xa inhibition activity. The kit can be used for 100 test reactions as per microtiter plate protocol.
Validation of factor xa assay for heparin sodium heparin injectionkrishgen
This document summarizes the procedures for using a chromogenic assay kit to quantify heparin levels in samples by measuring heparin's anti-factor Xa activity. The kit utilizes heparin's ability to catalyze the reaction between factor Xa and antithrombin III, which allows the residual factor Xa activity to be measured and used to determine heparin concentration in unknown samples. The document outlines the materials provided, reconstitution procedures, standard and sample preparation steps, assay procedure, and methods for data analysis and interpretation of results.
Validation of Factor IIa assay for nadroparin calcium or nadroparin injectionkrishgen
A chromogenic assay intended for the quantitative determination in purified solutions by measurement of factor IIa or Xa inhibition activity. The kit can be used for 100 test reactions as per microtiter plate protocol.
Validation of Factor IIa for heparin sodium or heparin injectionkrishgen
A chromogenic assay intended for the quantitative determination in purified solutions by measurement of factor IIa or Xa inhibition activity. The kit can be used for 100 test reactions as per microtiter plate protocol.
Validation of factor xa assay for nadroparin calcium nadroparin injectionkrishgen
This document describes a chromogenic assay used to quantify the anticoagulant Nadroparin in samples by measuring its inhibitory effect on factor Xa. The assay involves incubating Nadroparin samples with factor Xa and anti-thrombin III, then adding a chromogenic substrate and measuring the absorbance. The absorbance is inversely proportional to the Nadroparin concentration as it inhibits factor Xa activity. The assay kit and procedure are validated for use in quantifying Nadroparin levels in bioequivalence studies.
Validation of factor i ia assay for tinzaparin sodium-tinzaparin injectionkrishgen
chromogenic assay intended for the quantitative determination in purified solutions by measurement of factor IIa or Xa inhibition activity. The kit can be used for 100 test reactions as per microtiter plate protocol.
Validation of factor xa assay for dalteparin sodium dalteparin injectionkrishgen
chromogenic assay intended for the quantitative determination in purified solutions by measurement of factor IIa or Xa inhibition activity. The kit can be used for 100 test reactions as per microtiter plate protocol.
Validation of factor xa assay for enoxaparin sodium enoxaparin injectionkrishgen
chromogenic assay intended for the quantitative determination in purified solutions by measurement of factor IIa or Xa inhibition activity. The kit can be used for 100 test reactions as per microtiter plate protocol.
Validation of Factor IIa assay for enoxaparin sodium or enoxaparin injectionkrishgen
A chromogenic assay intended for the quantitative determination in purified solutions by measurement of factor IIa or Xa inhibition activity. The kit can be used for 100 test reactions as per microtiter plate protocol.
Validation of factor xa assay for heparin sodium heparin injectionkrishgen
This document summarizes the procedures for using a chromogenic assay kit to quantify heparin levels in samples by measuring heparin's anti-factor Xa activity. The kit utilizes heparin's ability to catalyze the reaction between factor Xa and antithrombin III, which allows the residual factor Xa activity to be measured and used to determine heparin concentration in unknown samples. The document outlines the materials provided, reconstitution procedures, standard and sample preparation steps, assay procedure, and methods for data analysis and interpretation of results.
Validation of Factor IIa assay for nadroparin calcium or nadroparin injectionkrishgen
A chromogenic assay intended for the quantitative determination in purified solutions by measurement of factor IIa or Xa inhibition activity. The kit can be used for 100 test reactions as per microtiter plate protocol.
Validation of Factor IIa for heparin sodium or heparin injectionkrishgen
A chromogenic assay intended for the quantitative determination in purified solutions by measurement of factor IIa or Xa inhibition activity. The kit can be used for 100 test reactions as per microtiter plate protocol.
Validation of Factor II and Xa Chromogenic Assays for Dalteparin, Enoxaparin,...krishgen
A chromogenic assay intended for the quantitative determination in purified solutions by measurement of factor IIa or Xa inhibition activity. The kit can be used for 100 test reactions as per microtiter plate protocol.
Development and validation of HPLC method for the estimation of Escitalopram ...pharmaindexing
This document describes the development and validation of a HPLC method for the estimation of Escitalopram oxalate in tablets. Key points:
- An isocratic HPLC method was developed and validated for the simultaneous determination of Escitalopram in pharmaceutical formulations.
- The method used a C18 column, mobile phase of acetonitrile:methanol:ammonium acetate buffer, and UV detection at 238nm. Escitalopram had a retention time of 5.36 minutes.
- The method was validated per ICH guidelines and found to be linear, precise, accurate, rugged and robust. Analysis of tablet formulations found Escitalopram levels within 100% of claimed content.
This study investigated the ability of crude extracts from Piper samentosum leaves, extracted using hexane and ethyl alcohol as solvents, to inhibit the growth of Culex mosquito larvae. The leaves were extracted in each solvent for 5 days. The weights of the extracts were measured and their ability to kill Culex larvae at different concentrations over 24 hours was tested. Statistical analysis showed that ethyl alcohol extracted more material from the leaves but hexane extracted material had a lower LC50 (the concentration that kills 50% of larvae), meaning it was more effective at inhibiting larval growth.
1) The experiment tested the toxicity of 3,5-DCP on bioluminescent bacteria by exposing bacteria to different concentrations of the chemical and measuring inhibition of light emission.
2) Exposing bacteria to increasing concentrations of 3,5-DCP from 0 to 40 mg/L resulted in increasing inhibition from 0% to 99%, establishing a dose-response relationship.
3) The effective concentration that caused 50% inhibition (EC50) was calculated to be approximately 11 mg/L based on the dose-response curve.
Stability indicating method development and validation for the estimation of ...SriramNagarajan18
Stability indicating method development and validation for the estimation of Doxorubicin by using RP-HPLC method in a bulk and pharmaceutical dosage form
Method Development and Validation on Etomidate injection by RP-HPLCpharmaindexing
This document describes the development and validation of a high performance liquid chromatography (HPLC) method for the analysis of etomidate injection. The method uses a Waters HPLC system with a Develosil-ODS-UG column and a mobile phase of acetonitrile and phosphate buffer at a ratio of 40:60. The method was validated per ICH guidelines and found to be accurate, precise, linear, robust and sensitive for quantifying etomidate in injections. The method was then applied to analyze etomidate levels in marketed injection formulations.
GC Head space Analysis, Residual Solvents by GC-HS, ICH Guidelines, ICH Q3C (R6), Pharmaceutical impurities, Impurities in pharmaceuticals, Drug substances, drug products, drug excipient, Residual solvent analysis.
Solvents are critical inputs in synthetic processes. An appropriate solvent for synthesis of drug substance may enhance the yield or determine characteristics such as polymorph, purity, solubility and bio-availability. After the desired form of drug substance is achieved, solvents are no longer needed as they do not provide any therapeutic benefit. All residual solvents should, ideally be removed completely to meet product specifications, good manufacturing practices, and other quality-based requirements. However, manufacturing processes cannot remove the solvents completely from drug substances and products and some residue of them are left in pharmaceuticals.
The precise amount of a solvent can be measured in direct injection method, based on its concentration and volume of the injection. However, in GC headspace this is not possible since saturated vapors of solvents, accumulated over headspace, are fed into GC system. Responses of respective solvents depend on their relative vapor pressure in diluent which in turn depends on the nature and volume of the diluent. Therefore, weight calculation of impurity or solvent in GC headspace analyses is not straightforward, the topic of this lecture.
https://youtu.be/uViLLtaOlnk
Determination of Chloramphenicol in Bulk Drug and Pharmaceutical Dosage Forms...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
Spectrophotometric Determination of Cardiovascular DrugsIJMER
International Journal of Modern Engineering Research (IJMER) is Peer reviewed, online Journal. It serves as an international archival forum of scholarly research related to engineering and science education.
In vitro conservation of Centella asiatica (Linn.)Urban. and Bacopa monnieri ...Sugandika Weerasinghe
1) The document describes an in vitro study of Centella asiatica and Bacopa monnieri, two medicinal plants known to have antioxidant properties.
2) Explants from both plants were cultured on MS medium and multiple shoots were successfully induced from nodal explants and leaves.
3) Extracts from Centella asiatica were evaluated for antioxidant activity using DPPH and FRAP assays, and for antifungal activity against Aspergillus niger. The extracts showed free radical scavenging and ferric ion reducing abilities.
TOYOPEARL MX-Trp-650M Robustness in mAb Aggregate removalTosohBioscience
TOYOPEARL MX-Trp-650M
• TSKgel G3000SWxl
• Example mAb
• Heat induced aggregation was enforced by incubation at 75 °C for 5
min Quantitative analysis via SEC
• Human γ-globulin
• DBC10: 1 g/l protein solution was loaded applying 150 cm/h. 100 mM acetate
buffer was set to the corresponding pHs, conductivity was adjusted with
sodium chloride. Columns: 6.6 mm ID x 2.1 ml L.
• Aggregate removal experiments: 4 g aggregated antibody per ml resin were
loaded, flow: 150 cm/h, load: 100 mM acetate, pH 5.0, 20 mS/cm, elute: 100
mM acetate, pH and conductivity as will be mentioned. Conductivity was
adjusted by adding sodium chloride. A linear gradient from 0-100 % B over
50 CV was applied. Yields were calculated by AUC.
• The goal of the study was to investigate the extent of the operating frame of
MX-Trp-650M for an example application.
Validated RP-HPLC Method for the Determination of Nelaribine in Bulk and Tabl...ijtsrd
A novel, simple and economic reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the estimation of Nelaribine in bulk and tablet dosage form with greater precision and accuracy. Separation was achieved on Cosmiscil C18 column (150X4.6mm i.d.,5-µm) in isocratic mode using Triflouro acetic acid PH-3.6 buffer and Acetonitrile in the ratio of 90:10(v/v) as mobile phase, pumped in to the column at flow rate of 1.0 mL min-1and the detection of eluent from the column was carried out using variable wavelength UV detector at 248 nm. The total run time was 15 min and the column was maintained at ambient temperature. The retention time of Nelaribine was 4.003 min. The standard curves were linear over the concentration range of 25-150 -µg/ml with R2 0.999 and the LOD and LOQ values for Nelaribine were 0.04 -µg/ml and 0.12 -µg/ml , respectively. The percentage recovery was found to be 101.76 “ 98.72 %, the % RSD was found to be 0.43. The percentage amount of a marketed tablet formulation of Nelaribine was found to be 101.2 %. The method was validated as per ICH guidelines. Validation studies demonstrated that the proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible. Hence the proposed method can be applied for the routine quality control analysis of Nelaribine in bulk and tablet dosage forms. Mrs.P.D.Chaithanya Sudha | Prof.D.Gowri Sankar"Validated RP-HPLC Method for the Determination of Nelaribine in Bulk and Tablet Dosage Form" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-1 | Issue-4 , June 2017, URL: http://www.ijtsrd.com/papers/ijtsrd181.pdf http://www.ijtsrd.com/pharmacy/analytical-chemistry/181/validated-rp-hplc-method-for-the-determination-of-nelaribine-in-bulk-and-tablet-dosage-form/mrspdchaithanya-sudha
Validated stability indicating RP-HPLC method for the simultaneous determinat...pharmaindexing
Validated stability indicating RP-HPLC method for the simultaneous determination of ofloxacin, ornidazole, clobetasol propionate, terbinafine hydrochloride, methyl paraben, propyl paraben in bulk and pharmaceutical dosage form
The document contains 4 tables presenting laboratory test results. Table 1 shows the mean, minimum, and maximum values for Troponin I, CKMB, D-Dimer, and Myoglobin levels in a sample of 13 patients. Table 2 shows a strong correlation between Troponin I levels measured using two different assays. Table 3 indicates no significant difference in D-Dimer levels between male and female patients. Table 4 reveals a high correlation between D-Dimer levels measured using citrated and EDTA blood collection tubes.
Mycotoxins are strictly regulated around the world because of their strong carcinogenic effects. A simple and reliable method to analyze mycotoxins is required to ensure food safety. The current methods require time-consuming sample pretreatment. This presentation reports on a fully automated online sample extraction and analysis of mycotoxins in foods by online SFE-SFC-MS.
Analytical Method Development and Validation of Tolvaptan in Bulk and Tablet ...pharmaindexing
This document describes the development and validation of a reverse phase high performance liquid chromatographic (RP-HPLC) method for the estimation of Tolvaptan in pharmaceutical dosage forms. A C18 column was used with a mobile phase of sodium dihydrogen phosphate and acetonitrile. The method was validated per ICH guidelines and showed good linearity, accuracy, precision, specificity, and robustness. Recovery of Tolvaptan from formulations ranged from 99.74-99.87% indicating the method is accurate for quantifying Tolvaptan in tablets.
Analysis of analgesics and antipyretics.induhdghcfgfgftf
The document summarizes analytical methods for several analgesics and antipyretics. It discusses classification of analgesics and antipyretics and their mechanisms of action. Specific analytical methods covered include titrimetric, spectrophotometric, chromatographic and colorimetric assays for drugs like aspirin, diclofenac sodium, aceclofenac, ibuprofen, paracetamol, analgin and antipyrine. Gravimetric, colorimetric and polarographic methods are described for the analysis of antipyrine.
This document outlines a study to screen and analyze selected plant species for their antioxidant properties. The objectives are to:
1. Screen 3-4 plant species from forest regions for antioxidant properties.
2. Identify primary and secondary metabolites in plant extracts.
3. Isolate and quantify bioactive antioxidant compounds and determine medicinal value.
4. Compare antioxidant profiles between plant species.
Plants will be extracted using solvent extraction. Phytochemical analysis will test for compounds like alkaloids, flavonoids, tannins. Total phenolic content and flavonoid content will be determined colorimetrically. Antioxidant capacity will be evaluated using DPPH, ABTS, hydroxy
Validation of Factor II and Xa Chromogenic Assays for Dalteparin, Enoxaparin,...krishgen
A chromogenic assay intended for the quantitative determination in purified solutions by measurement of factor IIa or Xa inhibition activity. The kit can be used for 100 test reactions as per microtiter plate protocol.
Development and validation of HPLC method for the estimation of Escitalopram ...pharmaindexing
This document describes the development and validation of a HPLC method for the estimation of Escitalopram oxalate in tablets. Key points:
- An isocratic HPLC method was developed and validated for the simultaneous determination of Escitalopram in pharmaceutical formulations.
- The method used a C18 column, mobile phase of acetonitrile:methanol:ammonium acetate buffer, and UV detection at 238nm. Escitalopram had a retention time of 5.36 minutes.
- The method was validated per ICH guidelines and found to be linear, precise, accurate, rugged and robust. Analysis of tablet formulations found Escitalopram levels within 100% of claimed content.
This study investigated the ability of crude extracts from Piper samentosum leaves, extracted using hexane and ethyl alcohol as solvents, to inhibit the growth of Culex mosquito larvae. The leaves were extracted in each solvent for 5 days. The weights of the extracts were measured and their ability to kill Culex larvae at different concentrations over 24 hours was tested. Statistical analysis showed that ethyl alcohol extracted more material from the leaves but hexane extracted material had a lower LC50 (the concentration that kills 50% of larvae), meaning it was more effective at inhibiting larval growth.
1) The experiment tested the toxicity of 3,5-DCP on bioluminescent bacteria by exposing bacteria to different concentrations of the chemical and measuring inhibition of light emission.
2) Exposing bacteria to increasing concentrations of 3,5-DCP from 0 to 40 mg/L resulted in increasing inhibition from 0% to 99%, establishing a dose-response relationship.
3) The effective concentration that caused 50% inhibition (EC50) was calculated to be approximately 11 mg/L based on the dose-response curve.
Stability indicating method development and validation for the estimation of ...SriramNagarajan18
Stability indicating method development and validation for the estimation of Doxorubicin by using RP-HPLC method in a bulk and pharmaceutical dosage form
Method Development and Validation on Etomidate injection by RP-HPLCpharmaindexing
This document describes the development and validation of a high performance liquid chromatography (HPLC) method for the analysis of etomidate injection. The method uses a Waters HPLC system with a Develosil-ODS-UG column and a mobile phase of acetonitrile and phosphate buffer at a ratio of 40:60. The method was validated per ICH guidelines and found to be accurate, precise, linear, robust and sensitive for quantifying etomidate in injections. The method was then applied to analyze etomidate levels in marketed injection formulations.
GC Head space Analysis, Residual Solvents by GC-HS, ICH Guidelines, ICH Q3C (R6), Pharmaceutical impurities, Impurities in pharmaceuticals, Drug substances, drug products, drug excipient, Residual solvent analysis.
Solvents are critical inputs in synthetic processes. An appropriate solvent for synthesis of drug substance may enhance the yield or determine characteristics such as polymorph, purity, solubility and bio-availability. After the desired form of drug substance is achieved, solvents are no longer needed as they do not provide any therapeutic benefit. All residual solvents should, ideally be removed completely to meet product specifications, good manufacturing practices, and other quality-based requirements. However, manufacturing processes cannot remove the solvents completely from drug substances and products and some residue of them are left in pharmaceuticals.
The precise amount of a solvent can be measured in direct injection method, based on its concentration and volume of the injection. However, in GC headspace this is not possible since saturated vapors of solvents, accumulated over headspace, are fed into GC system. Responses of respective solvents depend on their relative vapor pressure in diluent which in turn depends on the nature and volume of the diluent. Therefore, weight calculation of impurity or solvent in GC headspace analyses is not straightforward, the topic of this lecture.
https://youtu.be/uViLLtaOlnk
Determination of Chloramphenicol in Bulk Drug and Pharmaceutical Dosage Forms...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
Spectrophotometric Determination of Cardiovascular DrugsIJMER
International Journal of Modern Engineering Research (IJMER) is Peer reviewed, online Journal. It serves as an international archival forum of scholarly research related to engineering and science education.
In vitro conservation of Centella asiatica (Linn.)Urban. and Bacopa monnieri ...Sugandika Weerasinghe
1) The document describes an in vitro study of Centella asiatica and Bacopa monnieri, two medicinal plants known to have antioxidant properties.
2) Explants from both plants were cultured on MS medium and multiple shoots were successfully induced from nodal explants and leaves.
3) Extracts from Centella asiatica were evaluated for antioxidant activity using DPPH and FRAP assays, and for antifungal activity against Aspergillus niger. The extracts showed free radical scavenging and ferric ion reducing abilities.
TOYOPEARL MX-Trp-650M Robustness in mAb Aggregate removalTosohBioscience
TOYOPEARL MX-Trp-650M
• TSKgel G3000SWxl
• Example mAb
• Heat induced aggregation was enforced by incubation at 75 °C for 5
min Quantitative analysis via SEC
• Human γ-globulin
• DBC10: 1 g/l protein solution was loaded applying 150 cm/h. 100 mM acetate
buffer was set to the corresponding pHs, conductivity was adjusted with
sodium chloride. Columns: 6.6 mm ID x 2.1 ml L.
• Aggregate removal experiments: 4 g aggregated antibody per ml resin were
loaded, flow: 150 cm/h, load: 100 mM acetate, pH 5.0, 20 mS/cm, elute: 100
mM acetate, pH and conductivity as will be mentioned. Conductivity was
adjusted by adding sodium chloride. A linear gradient from 0-100 % B over
50 CV was applied. Yields were calculated by AUC.
• The goal of the study was to investigate the extent of the operating frame of
MX-Trp-650M for an example application.
Validated RP-HPLC Method for the Determination of Nelaribine in Bulk and Tabl...ijtsrd
A novel, simple and economic reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the estimation of Nelaribine in bulk and tablet dosage form with greater precision and accuracy. Separation was achieved on Cosmiscil C18 column (150X4.6mm i.d.,5-µm) in isocratic mode using Triflouro acetic acid PH-3.6 buffer and Acetonitrile in the ratio of 90:10(v/v) as mobile phase, pumped in to the column at flow rate of 1.0 mL min-1and the detection of eluent from the column was carried out using variable wavelength UV detector at 248 nm. The total run time was 15 min and the column was maintained at ambient temperature. The retention time of Nelaribine was 4.003 min. The standard curves were linear over the concentration range of 25-150 -µg/ml with R2 0.999 and the LOD and LOQ values for Nelaribine were 0.04 -µg/ml and 0.12 -µg/ml , respectively. The percentage recovery was found to be 101.76 “ 98.72 %, the % RSD was found to be 0.43. The percentage amount of a marketed tablet formulation of Nelaribine was found to be 101.2 %. The method was validated as per ICH guidelines. Validation studies demonstrated that the proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible. Hence the proposed method can be applied for the routine quality control analysis of Nelaribine in bulk and tablet dosage forms. Mrs.P.D.Chaithanya Sudha | Prof.D.Gowri Sankar"Validated RP-HPLC Method for the Determination of Nelaribine in Bulk and Tablet Dosage Form" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-1 | Issue-4 , June 2017, URL: http://www.ijtsrd.com/papers/ijtsrd181.pdf http://www.ijtsrd.com/pharmacy/analytical-chemistry/181/validated-rp-hplc-method-for-the-determination-of-nelaribine-in-bulk-and-tablet-dosage-form/mrspdchaithanya-sudha
Validated stability indicating RP-HPLC method for the simultaneous determinat...pharmaindexing
Validated stability indicating RP-HPLC method for the simultaneous determination of ofloxacin, ornidazole, clobetasol propionate, terbinafine hydrochloride, methyl paraben, propyl paraben in bulk and pharmaceutical dosage form
The document contains 4 tables presenting laboratory test results. Table 1 shows the mean, minimum, and maximum values for Troponin I, CKMB, D-Dimer, and Myoglobin levels in a sample of 13 patients. Table 2 shows a strong correlation between Troponin I levels measured using two different assays. Table 3 indicates no significant difference in D-Dimer levels between male and female patients. Table 4 reveals a high correlation between D-Dimer levels measured using citrated and EDTA blood collection tubes.
Mycotoxins are strictly regulated around the world because of their strong carcinogenic effects. A simple and reliable method to analyze mycotoxins is required to ensure food safety. The current methods require time-consuming sample pretreatment. This presentation reports on a fully automated online sample extraction and analysis of mycotoxins in foods by online SFE-SFC-MS.
Analytical Method Development and Validation of Tolvaptan in Bulk and Tablet ...pharmaindexing
This document describes the development and validation of a reverse phase high performance liquid chromatographic (RP-HPLC) method for the estimation of Tolvaptan in pharmaceutical dosage forms. A C18 column was used with a mobile phase of sodium dihydrogen phosphate and acetonitrile. The method was validated per ICH guidelines and showed good linearity, accuracy, precision, specificity, and robustness. Recovery of Tolvaptan from formulations ranged from 99.74-99.87% indicating the method is accurate for quantifying Tolvaptan in tablets.
Analysis of analgesics and antipyretics.induhdghcfgfgftf
The document summarizes analytical methods for several analgesics and antipyretics. It discusses classification of analgesics and antipyretics and their mechanisms of action. Specific analytical methods covered include titrimetric, spectrophotometric, chromatographic and colorimetric assays for drugs like aspirin, diclofenac sodium, aceclofenac, ibuprofen, paracetamol, analgin and antipyrine. Gravimetric, colorimetric and polarographic methods are described for the analysis of antipyrine.
This document outlines a study to screen and analyze selected plant species for their antioxidant properties. The objectives are to:
1. Screen 3-4 plant species from forest regions for antioxidant properties.
2. Identify primary and secondary metabolites in plant extracts.
3. Isolate and quantify bioactive antioxidant compounds and determine medicinal value.
4. Compare antioxidant profiles between plant species.
Plants will be extracted using solvent extraction. Phytochemical analysis will test for compounds like alkaloids, flavonoids, tannins. Total phenolic content and flavonoid content will be determined colorimetrically. Antioxidant capacity will be evaluated using DPPH, ABTS, hydroxy
This document describes various in vitro and in vivo screening methods for evaluating anticholinesterase agents. It outlines assays measuring acetylcholinesterase and butyrylcholinesterase inhibition in rat and human tissues. In vivo methods include inhibitory avoidance tests in rodents using step-down, step-through, and uphill avoidance tasks. Other tests involve active avoidance, discrimination learning, and conditioned response tasks to assess effects on memory and learning. The document provides detailed procedures, reagents, and evaluations for each screening method.
Method development and validation for the estimation of Atorvastatin, Ezitimi...SriramNagarajan18
Method development and validation for the estimation of Atorvastatin, Ezitimibe and Fenofibrate in bulk and pharmaceutical dosage forms by RP-HPLC method
Analytical method development and validation for the estimation of aspirin an...SriramNagarajan19
A simple and selective LC method is described for the determination of Aspirin and Omeprazole in tablet dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of 30 volumes of ammonium acetate buffer, 40 volumes of acetonitrile and 30 volumes of Methanol with detection of 233 nm. Linearity was observed in the range 18-42 µg/ml for Aspirin (r2 =0.983) and 6-14 µg /ml for Omeprazole (r2 =0.970) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form.
Extraction of Secondary Metabolites from Roots of Acanthus Ilicifolius L and ...inventionjournals
The root extracts of Acanthus ilicifolius L finds a prominent place in folk medicine. In this study, we
extracted alkaloid, flavonoid, tannin and total phenols in benzene, ethyl acetate, acetone, methanol and
ethanol, their antibacterial activity and antioxidant activity was evaluated. The antioxidant activity is executed
by FRAP assay and agar well diffusion method is done to study the antibacterial activity against Enterobacter
aerogenes, Enterobacter cloacae, Escherichia coli, Bacillus subtilis, Staphylococcus aureus and Streptococcus
pyogenes. The antibacterial activity of all the extracts was compared with standard antibiotic gentamicin.
The Minimum Inhibitory Concentration [MIC] was determined by serial dilution method. Alkaloids are rich in
acetone and Flavonoids are high in methanol extracts. The acetone extract showed higher antioxidant activity,
while benzene extract was identified to contain lower antioxidant activity. The extent of inhibition by the root
extracts diverge between the solvents used, among them ethanol extracts exhibited higher level of inhibition
against the gram positive test cultures compared to gram negative test cultures employed. Whereas, the acetone
extracts efficacy is more on gram negative test cultures than the gram positive cultures. The MIC was found to
be between 1mg/100µl to 5mg/100µl. This study gives the source for purification and characterization of
bioactive principles that possess antioxidant and antibacterial action from the root of Acanthus ilicifolius.
1. The study aimed to evaluate the in-vitro and in-vivo antioxidant and anti-inflammatory properties of Thunbergia grandiflora and perform HPTLC fingerprinting and quantification of bioactive compounds.
2. Preliminary phytochemical screening of plant extracts showed the presence of alkaloids, flavonoids, phenols, saponins, carbohydrates, steroids and terpenoids. In-vitro assays demonstrated antioxidant and anti-inflammatory effects.
3. HPTLC fingerprinting was conducted and total phenolic content was found to be 233.6 mg GAE/g extract while total flavonoid content was 275.3 mg QE/g
Spectrophotometric Determination of Drugs and Pharmaceuticals by Cerium (IV) ...IOSR Journals
Simple, sensitive, accurate, and precise spectrophotometric methods for quantitative determination of drugs, viz., Darifenacin (DAR), Esmolol Hydrochloride (ESM), Montelukast Sodium (MON), Sildenafil citrate (SIL),Terbinafine (TER) and Tramadol Hydrochloride (TRA) were developed. The method of each drug depends upon oxidation of drugs by Ce (IV) (Excess) and estimating the amount of unreacted Ce (IV) by amaranth dye at 523nm. The calibration curves obeyed Beer’s law over the concentration range of 1.4-7.0 μg ml-1 (DAR), 2-14 μg ml-1 (ESM), 2-10 μg ml-1 (MON), 20-70 μg ml-1 (SIL), 3-21 μg ml-1 (TER) & 2-14 μg ml-1 (TRA). The methods have been validated in terms of guidelines of ICH and applied to analysis of pharmaceuticals.
This slide is about grape seed extract and their structures, along with the extraction methods of grape seed oils. explains about the uses and side effects.Their antioxidant property.
This document describes the development and validation of a stability-indicating HPLC method for the simultaneous quantification of four active pharmaceutical ingredients: pantoprazole, rabeprazole, lansoprazole, and domperidone. The method was developed using a C18 column with gradient elution of a mobile phase consisting of buffer and organic solvents. The method was validated per ICH guidelines and demonstrated selectivity, linearity, accuracy, precision, sensitivity and robustness. Forced degradation studies subjected the drugs to acid, base, oxidation, heat, and light conditions in order to evaluate the method's ability to separate drugs from degradation products.
This document describes the development and validation of a stability-indicating HPLC method for the simultaneous quantification of four active pharmaceutical ingredients: pantoprazole, rabeprazole, lansoprazole, and domperidone. The method was developed using a C18 column with gradient elution of a mobile phase consisting of buffer and organic solvents. The method was validated per ICH guidelines and demonstrated selectivity, linearity, accuracy, precision, sensitivity and robustness. Forced degradation studies subjected the drugs to acid, base, oxidation, heat, and light conditions in order to evaluate the method's ability to separate drugs from degradation products.
This document describes the separation and analysis of three samples sent to B&B Rod Co. by Mr. Smith using different chromatography techniques. For the first sample, caffeine content in an impure standard and coffee sample, HPLC was used. It found the impure standard contained 0.09967% caffeine with 55.66% error. For the second, TLC found an impure Allura Red AC sample contained 49.78% of the dye. For the third, GC found a mixture of alcohols contained 0.4786 mg/ml of Cetyl alcohol and 0.6177 mg/ml of Stearyl alcohol.
This document summarizes an experiment to isolate tissue plasminogen activator (tPA) from HeLa cell culture broth using magnetic nanoparticles (MNPs). tPA helps break down blood clots and has applications in thrombolytic therapy. The experiment involved binding tPA to MNPs, washing away unbound proteins, then eluting tPA from the MNPs. Absorbance measurements and assays showed tPA was present in the load and spent samples but concentrations were low in the eluates. SDS-PAGE and zymography gels confirmed tPA activity in the load and spent but not eluates, possibly due to low concentrations or protein denaturation during elution. The experiment demonstrated the potential
Tissue plasminogen activator (tPA) was successfully isolated from HeLa cell culture broth using magnetic nanoparticles (MNPs). MNPs were used to bind tPA, allowing separation from other proteins through washes and elutions. Samples from each step were analyzed through absorbance measurements, protein estimation assays, enzyme activity assays, SDS-PAGE gel electrophoresis and fibrin zymography. Results showed tPA was present in the initial HeLa cell load and spent samples, as well as the first elution, indicating tPA was successfully isolated using MNPs in a single step.
Similar to Validation of factor xa assay for tinzaparin sodium tinzaparin injection (20)
KRIBIOLISA Drug Monitoring ELISA Trastuzumabkrishgen
Kribiolisa ELISA kits for drug monitoring of therapeutic drugs like Adalimumab, Trastuzumab, Atezolizumab, Eculizumab, Ranibizumab. Sensitive assays for drug monitoring and immunogenicity. CE marked.
KRIBIOLISA Drug Monitoring ELISA Ranibizumabkrishgen
Kribiolisa ELISA kits for drug monitoring of therapeutic drugs like Adalimumab, Trastuzumab, Atezolizumab, Eculizumab, Ranibizumab. Sensitive assays for drug monitoring and immunogenicity. CE marked.
KRIBIOLISA Drug Monitoring ELISA Eculizumabkrishgen
Kribiolisa ELISA kits for drug monitoring of therapeutic drugs like Adalimumab, Trastuzumab, Atezolizumab, Eculizumab, Ranibizumab. Sensitive assays for drug monitoring and immunogenicity. CE marked.
KRIBIOLISA Drug Monitoring ELISA Atezolizumabkrishgen
Kribiolisa ELISA kits for drug monitoring of therapeutic drugs like Adalimumab, Trastuzumab, Atezolizumab, Eculizumab, Ranibizumab. Sensitive assays for drug monitoring and immunogenicity. CE marked.
This document describes KRIBIOLISA ELISA kits for measuring drug and anti-drug antibody levels, including their KRIBIOLISA ADALIMUMAB ELISA and KRIBIOLISA ANTI-ADALIMUMAB ELISA kits. It provides details on the kit catalog numbers, assay type, sample matrix, calibration range, regulatory status, and validation methodology. It also summarizes a study that established a therapeutic drug level range of 3.51-7.00 mg/L for adalimumab treatment of plaque psoriasis.
Validation of anti niv igm capture elisa version#1krishgen
NiV is a negative-sense, non-segmented RNA virus that was first isolated from cerebrospinal fluid of human patients and classified in the family Paramyxoviridae under the new genus
Henipavirus. Its genome encodes six structural proteins: the nucleocapsid (N) protein,
phosphoprotein (P), matrix (M) protein, fusion (F) protein, glycoprotein (G), and large (L)
protein.
Nipah virus glycoprotein G has a globular head domain formed of a six-bladed beta sheet propeller, connected via a flexible stalk domain to a transmembrane anchor. The G binds to the cellular receptors ephrin B2 are ephrin B3, mediating viral attachment. Following attachment Nipah Virus glycoprotein G undergoes a conformational change that leads to triggering of glycoprotein F which leads to membrane fusion (Biering et al, 2012).
The Nipah virus glycoprotein G is a recombinant protein expressed in mammalian HEK293 cells. It is presented as a fusion protein with a mouse Fc tag linked to the C-terminus of glycoprotein G, amino acids 71-602.
We established preliminary specifications defining acceptable ranges for the parameters indicated herein below for our Anti Nipah Virus IgM Capture ELISA kit. These parameters were tracked day-to-day, run-to-run, and operator-to-operator, over a schedule defined inhouse.
Recommended assay characteristics included absorbance of a zero concentration standard; factors which describe the calibration for each standard and statistical description of the calibration curve such as coefficient of correlation, slope and/or intercept; and recovery of results on control samples. It is important to be able to relate the specifications for a parameter to expected reliability of the result. Our in-house standard defined was r=0.990.
Validation of bevacizumab elisa ich q2 ver3,0 dt14.03krishgen
This document presents a discussion of the characteristics of our KRIBIOLISA™
BEVACIZUMAB ELISA kit considered by us during the validation of this kit in accordance
with ICH Q2 (R1) guidelines. The document is prepared based on tests run in our laboratory
and does not necessarily seek to cover the testing that may be required at user’s end for
registration in, or regulatory submissions. The objective of this validation is to demonstrate
that it is suitable for its intended purpose – detection of Bevacizumab (Avastin)
White Paper : Need for Standardization of Tests for Plant Viruseskrishgen
The document discusses the need to standardize virus testing procedures for tissue culture plants in India. Currently, each accredited testing laboratory uses its own in-house assays and methods, leading to inconsistent results. The author proposes that the Department of Biotechnology accredit standardized virus testing kits from commercial Indian manufacturers to be used uniformly across all testing laboratories. This would ensure a transparent, reproducible certification process and boost confidence among stakeholders in the tissue culture industry.
KRISHGEN is leading manufacturer of ELISA kits for measuring markers in rat serum or plasma. Citations are available for majority of the products and can be viewed on the website.
KRISHGEN is a leading manufacturer of fluroescent based assay kits which can be used on plate readers. With numerous citations for their products, the company is a leading assay and kits manufacturer.
Krishgen is an Indian biotech company established in 2003 that focuses on developing tools for the life sciences and agriculture industries. It has experienced strong growth, with revenues reaching $5 million in 2011. Krishgen provides products and services related to medical diagnostics, drug discovery research, biopharmaceuticals, and plant/food sciences. It aims to enable breakthroughs in biological research and disease treatment.
Krishgen is an Indian biotech company established in 2003 that focuses on developing tools for the life sciences and agri industries. It has experienced strong growth, with revenues reaching $5 million in 2011. The company provides products and services related to medical diagnostics, drug discovery research, biopharmaceuticals, and plant/food sciences.
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
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Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
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ABDOMINAL TRAUMA in pediatrics part one.drhasanrajab
Abdominal trauma in pediatrics refers to injuries or damage to the abdominal organs in children. It can occur due to various causes such as falls, motor vehicle accidents, sports-related injuries, and physical abuse. Children are more vulnerable to abdominal trauma due to their unique anatomical and physiological characteristics. Signs and symptoms include abdominal pain, tenderness, distension, vomiting, and signs of shock. Diagnosis involves physical examination, imaging studies, and laboratory tests. Management depends on the severity and may involve conservative treatment or surgical intervention. Prevention is crucial in reducing the incidence of abdominal trauma in children.
Validation of factor xa assay for tinzaparin sodium tinzaparin injection
1. Tinzaparin anti-FXa is a chromogenic assay intended for the
quantitative determination of Tinzaparin in purified solutions by
measurement of factor Xa inhibition activity.
The kit can be used for 100 test reactions as per microtiter plate
protocol.The inhibitory effect of anti-thrombin III (AT-III) on
thrombin, factor Xa and other coagulation serine proteases in
plasma is increased several thousand-fold by Tinzaparin. This
inhibition accounts for the anticoagulant effect of Tinzaparin.
The quantitative determination of Tinzaparin levels by the
measurement of their anti-Xa activity is a necessary tool for
monitoring treatment efficacy.
Presence of Tinzaparin catalyzes the reaction between factor Xa
and AT-III. The factor Xa inhibition test is the most useful assay
covering the widest variety of Tinzaparin preparations.
In the assay, the rate of factor Xa inhibition is directly proportional
to the Tinzaparin concentration since both factor Xa and AT-III are
in excess. The residual factor Xa activity is inversely proportional
to the Tinzaparin concentration.
Introduction
Materials and Method:
Result :
Data Interpretation :
Unit Nos#318/319, Shah & Nahar, Off Dr. E Moses Road, Worli, Mumbai, Maharashtra 400018 | Tel: 022 4919 8700 | Email: info@krishgen.com
Materials not provided are:
Reagent Materials require
Dilution Buffer 20mM Tris, pH 7.4 and 150mM NaCl
Stop Solution 20% v/v Glacial Acetic Acid
Recommended Standard
concentration
(considering 1mg=100IU)
0.20 IU/ml, 0.15 IU/ml, 0.10 IU/ml, and 0.05 IU/ml.
Assay Procedure :
Standard or Test Sample 50µl
Human Anti-thrombin III 50µl
Mix but do not allow bubbles to form. Incubate at 37⁰C, for
2 minutes
Bovine Factor Xa 50µl
Mix and incubate at 37⁰C, for exactly 2 minutes
Chromogenic Substrate 50µl
Mix and incubate at 37⁰C, for 2 minutes
Acetic Acid 50µl
Mix and measure the absorbance at 405nm
For each series, calculate the regression of the absorbance against log
concentration of the sample solutions and the standard solutions.
Calculate the potency of the Tinzaparin in IU of Anti-Factor Xa activity/ml using
statistical methods for parallel-line assays.
The four independent log relative potency estimates are then combined to obtain
the final geometric mean. Its confidence limits are calculated. Express the Anti-
Factor Xa activity of the sample in mg.
Standard and Test Samples being serial diluted should pass the test for linearity
and parallelism as the interpretation is done by extrapolating the data. We have
used proprietary MS Excel software for the same based on DJ Finney algorithm.
Conclusion :
The assay kits manufactured by KRISHGEN BIOSYSTEMS are validated
Chromogenic Assays for the determination of Tinzaparin using anti-Xa activity in
human plasma successfully met all standard assay-validation parameters and
were suitable for use in bioequivalence studies.
Authors:
Ms Prajakta Ambre, Ms Trupti Bendigeri, Ms Jyoti Gupta, Dr Amitabha De -
KRISHGEN BIOSYSTEMS R&D Laboratory
Materials provided in lyophilized form are :
Materials
Amount of DI
water for
reconstitution
(ml)
After Reconstitution
1:4 dilution
Human Anti-thrombin III
Reagent
1ml 100µl of M.S + 400µl of buffer
Bovine Factor Xa
Reagent
1ml 100µl of M.S + 400µl of buffer
Chromogenic Substrate 1ml 100µl of M.S + 400µl of H2O
Note : M.S denotes Reconstituted Main stock from Tinzaparin Sodium EPRS
Sr.no
Concentration
(IU/ml)
stock(µl)
Diluent (µl)
(buffer
pH7.4)
Total
volume
(µl)
S1 10
50 µl of Main
Stock
450 500
S2 1 50 µl of S1 450 500
S3 0.20 100 µl of S2 400 500
S4 0.15 75 µl of S2 425 500
S5 0.10 50 µl of S2 450 500
S6 0.05 25 µl of S2 475 500
Test Dilution – Test Sample Main Stock is of concentration
100IU/mL
Sr.no
Concentration
(IU/ml)
stock(µl)
Diluent (µl)
(buffer
pH7.4)
Total
volume
(µl)
T1 10
50 µl of Main
Stock
450 500
T2 1 50 µl of T1 450 500
T3 0.20 100 µl of T2 400 500
T4 0.15 75 µl of T2 425 500
T5 0.10 50 µl of T2 450 500
T6 0.05 25 µl of T2 475 500
Standard and Test Sample preparation
Example - Standard Concentration 100 IU/mL (Main
Stock) is to be diluted as per below table:
Standard
concentration
IU/ml
Absorbance at
405nm
Set-1 Set-2
0.05 0.6875 0.6983
0.10 0.2886 0.42
0.15 0.2541 0.2396
0.20 0.1921 0.1604
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
0.04 0.08 0.12 0.16
Absorbanceat405nm
Standard Concentration IU/ml
FXa-NAD SET-1
FXa-NAD SET-2
KRIBIOLISA Tinzaparin anti F-Xa Assay kit, Cat # KBBA04T