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field detection devices for screening the quality of medicines: a systematic review

by:KingKonree     2020-02-04
Background Poor drugs have devastating consequences.
A large number of innovative portable devices for screening inferior drugs have emerged, which has led to the hope that these devices will empower drug inspectors and strengthen monitoring.
However, information comparing these new technologies is scarce.
Methods As of April 30, 2018, we systematically reviewed EMBASE, PubMed, Web of Science and SciFinder databases.
This includes scientific research that evaluates the performance/capability of portable devices to assess any aspect of drug quality. Results Forty-
A device, from a small desktop spectrometer to a laboratory-on-a-chip’ single-
Includes equipment that costs between $10 and $20,000.
Only six devices are on site. -tested (GPHF-
Small Laboratory, CD3/CD3+, Truscan rm, Side Flow Test Paper Immunoassay, CBEX and Rapid Varieties). The median (range)
Quantity of active drug components(APIs)
The evaluation results for each equipment are only 2. (1–20).
Most devices promise to distinguish between genuine and counterfeit drugs.
Devices that are likely to analyze APIs(semi)-
Quantitatively consumable and destructive(GPHF-
Small Laboratory, Pharmaceutical Company, APADS, Side Flow Immunoassay Test Paper, Test Paper-
Microfluidic strip and capillary electrophoresis)
Except for spectroscopic devices.
However, the ability of 10 spectroscopic devices to test their quantitative APIs requires the processing of complex APIs. -
Specific calibration model.
Scientific evidence shows that the device can accurately test liquids, capsules or local preparations, or distinguish chiral molecules, is limited.
No comment on cost-
There is little information about the effectiveness and optimal deployment of these devices in the drug supply chain.
CONCLUSION Although many portable on-site testing devices can be used for drug quality screening, it is very important to lack independent evaluation for most of the devices, especially in the on-site environment.
In-depth research is needed to inform national drug regulators of the best options(2)
Those focused on API(s)detection only; (3)
Those \"physical analysis devices\" mainly evaluate the physical properties of samples, not chemical properties. and (4)
Those with the ability to detect microbial contamination.
A summary of the reference requirements for each device is provided in online supplementary document 4. All extracted information is shown in online supplementary documents 5 and 6.
Supplementary information[bmjgh-2018-000725-SP4. pdf]
Formula Screening Equipment The equipment in this section checks the chemical \"fingerprints\" of the formula. both API(s)and excipients)
And classify them according to whether quantitative API analysis ability test has been carried out or not.
The ability of these devices to distinguish between the poor and the good-
The quality of drugs and the quantification of APIs depend not only on the performance of equipment, but also on the collection and post-processing of spectral data by relevant software.
They all need spectral reference libraries, but usually do not require them. -
It is destructive and does not require consumables.
Whether the testing equipment is capable of quantitative analysis of API. As far as we know, there is no built-in software to provide quantitative analysis of API.
The performance results of the quantitative capabilities of the devices described in this section are obtained after data processing in the laboratory.
Raman Truscan Room(
Thermodynamics)
Is it one of the six devices tested on site? (table 2).
It distinguishes 14 pools(
Counterfeit and degradable drugs)
Seventy genuine antimalarials are 100% sensitive and 99% specific. 15 Forty-
Four forged samples(
Eight different products)
And 62 genuine formulations(
Undeclared APIs, a total of 33 \"product lines\"
The accuracy is 100%.
16. Truscan exhibits similar matching/failure performance in drug identification. (
Although the signal resolution is low)
Compared with Raman desktop instrument.
16-18 View this table: View the main features and performance results of the inline view pop-up 2 field-
After sample preparation, 14 Viagra samples were tested with special reagents in mail facilities. (
12 Containing sildenafil)
With the truss RM, the accuracy is 91.
7% Qualitative Identification of Sildenafil(
Fourier transform-Infrared (FT-IR)
Analysis as a Reference Technology).
19 different advantages(
Simulated \"substandard\" drugs
In the same APIs and brands, matching/mismatching is not a reliable way to distinguish. -match approach.
In addition, a third of the placebos passed the accreditation test by mistake, rather than the API strength test.
16 in P-Value Survey(
Sample threshold limits for \"pass\" or \"fail\"
Five products containing candesartan were scanned by TruScan rm, and the P value could be set to 0. 40 (instead of 0. 05)
In order to better distinguish the substandard drugs whose content of APIs is less than 50% or more from the drugs. -
High quality products.
However, considering the small sample size, these results should be taken with caution.
First defender Traska(
Replaced by TruScan rm)
The number of APIs has been determined to be less than 1.
The reference contents of acetylsalicylic acid, ascorbic acid and caffeine were 6%-12%.
22 Mega Euro Real-time Raman Analyser(MIRA, Metrohm)
Identification of Adriamycin Injected in Different Concentrations(n=90)
Epirubicin(n=90)
Through glass containers, it has 100% sensitivity and specificity.
Quantitative determination of coefficients(r2)of 0. It is reported that there are 99 people. 23The EZRaman-I (TSI)
By using the Raman binary bar code method containing the reference library of API Raman spectra, the APIs in four pharmaceutical products containing amoxicillin, acyclovir and doxycycline 24 were qualitatively identified.
25. Ezraman predicts the results of the percentage of APIs claimed on an average of five labels per sample. -
I\'m within 3% of the high performance liquid chromatography results for three quarters of the products, and one of them has a value of 6.
It is 0% lower than that of high performance liquid chromatography.
Among 14 infrared-based devices(IR)/Mid-Infrared (Mid-IR)
Miniature Thermal Infrared(
Its predecessor was Fazil.
Small samples of different types of APIs or finished products were tested in the laboratory.
The spectral data of 2226-33 have been successfully obtained by using transparent blister packaging of six experimental samples.
Quantitative results of acetylsalicylic acid, ascorbic acid and caffeine in 28 tablets were similar to those of reference Fourier transform. -Near-Infrared (FT-NIR)instrument. 22. Trace Elements(
JDSU, then Viavi)
And TruDefender FT(
Thermodynamics)
It has been used to quantify API to less than 0. 1%–7.
8% of the references were used for weight loss and erectile dysfunction drugs, as well as acetylsalicylic acid, ascorbic acid and caffeine. 22 34The SCiO (
Consumer Physics)
The device has 100% specificity and sensitivity for the identification of counterfeits. (n=42)
With the Real(n=54)
The content of amodiquine in the antimalarial drug but not in the energetic product.
The device can be used to determine 95% artesunate in 15 kinds of oral products.
35 miniature desktop QDA single quadrupole mass spectrometer(Waters)
Correct identification of artemisinin-
Basic combination therapy(ACT)
Counterfeit antimalarial drugs were seized in 192 countries, including artemether + lumifendine and other compounds, such as chloramphenicol, ciprofloxacin and sugar.
The relative strength of each compound detected can be compared successively between tablets and used as an API quantitative agent.
For quantitative analysis, it has been proved that hand-held micro-10 mass spectrometer can produce parts. -per-
The one billion test limits for drug abuse are 37, but fecal drugs have not yet been assessed.
Devices with untried potential for quantitative analysis of free Raman devices. (MiniRam II (B&W Tek)
Raman RxN1 microprobe(Kaiser Optical)
And Ezraman M analyzer(
Electron wave electronics))
26 38 39 and around 9-infrared/mid-
Infrared equipment(
Multifunctional analyzer(Bruker Optics)Brightness 5030(Brimrose), RxSpec 700Z (ASD), Exoscan (A2 technology), MLp (A2 technology), FT/IR-4100 (JASCO), Cary 630 (Agilent)Nicole is 10(
Thermodynamics)
Target Mixed Analyser(
Thermodynamics))
Included in small-
Scale laboratory research.
Note 26 29 30 40 41, CBEX(Metrohm Raman)
The presence of paracetamol, amoxicillin, rumefenadine and pyrazinamide in various APIs/APIs combinations has been successfully identified, but no other fixed APIs have been identified. -
Drug combination, (
For example, artemether in artemether-
Lumefantrine film)
And furosemide and oxytocin in single API injection samples.
42 According to the API and degradation degree/type, a limited group of artificial degradation samples were accurately identified.
Field assessment of the utility of the equipment, not its performance. (table 2)
The proposal was also made by 10 operators with various technical experience from Indian and Zimbabwean regulatory authorities. -
Operating equipment requires less than two weeks of training. 42The NanoRam (B&W Tek)
It showed 100% sensitivity and 96% specificity. (
For TLC, samples were confirmed by high performance liquid chromatography, but TLC failed.
Investigation of 289 antimalarial samples(
Including 24 counterfeit and 22 experimental \"false API counterfeits\" containing paracetamol. .
4344A prototype nuclear quadrupole resonance(NQR)
The device has been successfully applied to the identification of ampicillin in capsules and paracetamol in tablets.
At present, there is no data report on its sensitivity and specificity.
45 Target API Detection Devices Most of the devices in this section are half-quantitative.
All technologies require sample destruction, and most require sample pretreatment. (For example, dissolution).
Some provide qualitative and quantitative information, and may also provide data for other attributes. (
For example, disintegration characteristics).
Others only identify APIs qualitatively.
Quantitative and semi-quantitative-
Quantitative Targeting API Detection Device GPHF-Minilab (
Global Pharmaceutical Health Fundis a ‘lab-in-a-
The suitcase contains supplies for visual inspection of drugs. (
Formulation and packaging)
Identify and Half-
TLC was used to quantify the prescribed APIs and disintegration test was carried out.
It\'s one of six areas. -
Testing equipment identified in this review(table 2).
Field Survey of 84 Antimalarial Drugs(
Including 14 substandard/forged samples)
In Ghana, 100% sensitivity and specificity were reported for small TLC identification based on high performance liquid chromatography reference analysis.
15 for API identification and semi--
The sensitivity and specificity of TLC were 79% and 100% respectively.
In Brazil, 14/46(30%)
Quantitative TLC was used to determine the unqualified quinine samples. -quantitation.
However, all seven samples tested for validation were found to meet the specifications.
In the same study, 289 samples collected in Guyana were semi-quantitatively analyzed by TLC. -
Quantitative, but 5 out of 10 samples failed the subsequent validation test.
A multi-country survey in Africa found that 30% of the 31 countries that were very substandard were detected by micro-laboratories. -compliant (
In the dissolution test, the deviation between the determination by high performance liquid chromatography and the prescribed API is more than 20%, and/or the percentage of the API dissolved is more than 25% of the Pharmacopoeia limit Q.
Antimalarial samples.
However, dissolution and disintegration tests measure different aspects of solid preparations and we do not expect to be completely consistent.
TLC test failed to identify 77 unqualified antibiotics, 76 of which contained% API> 80% and < 123% in the label declaration.
97% specificity.
However, Mini-Labs are designed to detect samples with APIs below 80% threshold.
Variability among observers is considered to be an important factor in small and semi-laboratories. -
Quantitative inaccuracy.
46 49 In Tanzania, seven drug inspectors evaluated finished products containing four different APIs. (
Antibiotics and antimalarials)
At three different concentrations(0%, 40%, 100%). 49 Twenty-
Of the 28 substandard samples containing 40% APIs, 5 were mistaken for quality by TLC.
After further training, 8 of the 28 samples were still mistakenly identified as qualified.
All samples of 100% API, zero API and error API are correctly identified.
Pharmaceutical is an area-
Portable microfluidic devices are currently limited to artemisinin. -
The basic drugs were designed for quantitative analysis of raw materials and dissolution test of tablets.
Quantitative analysis of 503 oral artesunate preparations(
Average value of five samples for each formulation)
The accuracy was 0%-4% by high performance liquid chromatography. 50Single-
Side-flow immunoassay test paper(
Apparently similar to rapid malaria diagnostic tests)
Detection of artemisinin in feces with monoclonal antibodies-
Basic antimalarial drugs.
51-53 field survey samples(table 2)
The sensitivity or specificity could not be calculated because no reference technique was tested.
51 In laboratory tests, artesunate test paper showed 100% specificity for detecting artesunate against other commonly used antimalarial drugs, including other artesunate derivatives. 53 A semi-
Sample tandem dilution method was used to quantitatively analyze the content of APIs. 53A proof-of-
The concept paper describes the suitability of rapid red Tr reaction for the detection of artesunate on paper. -
Based on microfluidic control strip.
54 The card can detect the presence and relative concentration of artesunate in a real sample and the deficiency of artesunate and dihydroartemisinin in two preparations. Semi-
By using smart phone application program to analyze gray intensity, the quantitative accuracy is improved. A battery-
The electrokinetic capillary electrophoresis (ECCE) can successfully identify and quantify salbutamol and metoprolol in syrup and tablets.
The accuracy of the results determined by high performance liquid chromatography ranges from 3% to 13%. 55Paper cards (aPAD)
It has been successfully used in semi-finished products. -
Quantitative iodine back-
Titration of amoxicillin and ampicillin, test specified in the analysis of beta pharmacopoeia-
Lactam antibiotics.
These cards distinguish amoxicillin solutions with a concentration change of 0.
15 mg/ml, allowing the identification of unqualified amoxicillin < 83% of the marker API content.
56 APADS gives half-
Quantitative analysis of 13% and 5%. (
Compared with high performance liquid chromatography)
41 amoxicillin samples and 40 ampicillin samples were collected in Kenya.
In this study, samples identified by APADS contained less than/more than 90 ingredients in the US Pharmacopoeia.
0% limited drug% API, sensitivity 73. 2% and 80.
Amoxicillin 0%(n=80)
Ampicillin and Ampicillin(n=56)And(
100% characteristic).
The authors suggest that artificial degradation samples be prepared for research purposes. (
Thermal stress)
This may lead to a decrease in sensitivity.
By getting two-
Size Spectrum Data of Tablets for Near Infrared Imaging Equipment(D-NIRS)
It can evaluate the distribution of different chemical constituents in the dissolution process, 5859, but the device has no sensitive and specific data.
Pure qualitative targeted API testing equipment and support-
Quantitative analysis based on a chemical reaction(see above)
Paper analyzer(PADs)
Used for qualitative screening of APIs and excipients.
56,6061 independent lanes with different color measurement reactions produce \"color barcode\", which is compared with the reference library of \"standard color barcode image\".
Expert readers can even distinguish the different advantages of APIs.
61 The sensitivity of two antibiotics, three antituberculosis drugs and two antimalarial drugs was 76%-100% in the prescription test of known concentration. (n=9–60)
The specificity was 80%-100%. (n=30–135).
In the co-formed samples of 6061, the identification of APIs is more changeable.
For example, when testing for co-formed tuberculosis(TB)
In drug samples, ethambutol was not detected when 30% of the samples were actually present, and was erroneously reported when 17% of the samples did not exist.
30 2 in 60 test-
Tuberculosis samples, ethambutol and isoniazid formed by API were detected correctly in all samples.
602 ion mobility spectrometers were evaluated.
62 63 Eskan-LS (
Smith test)
The raw materials of erectile dysfunction drugs in 26 Chinese medicine supplements with 100% sensitivity and specificity were tested, and 13 of the 15 supplements were successfully identified as specific raw materials. (87%)samples.
63 knives 4000(
Smith test)
The results were similar to those of sibutramine, a dietary supplement, detected by a desktop ion mobility analyzer.
62 The equipment in this section examines the physical properties of the samples, such as their visual appearance.
They cannot verify the existence or absence of APIs.
Since counterfeit packaging is the key to identifying counterfeit drugs, they may have important parallel functions with chemical analysis devices.
Visual/Color Check Counterfeit Detection Device CD3 + Displays the Difference between Test Samples and Real Samples(
Packaging and formulation)
By allowing users to compare their appearance under different ultraviolet rays-
Visible and Infrared Rays(IR)wavelengths.
1564-66 Using this technique, fake and authentic samples of artesunate blister packaging were fabricated. (n=203)
The sensitivity and specificity were 98.
4% and 100% respectively, with 100% inter-user reliability.
64. Field research(table 2)
84 artemisinin-
The sensitivity and specificity of combination therapy were 100% and 53%. (
About packaging materials and dosage unitsand 64% (
Only in dosage units). 15The X-Rite Eye-
One is an optical spectrophotometer, which projects light with a wavelength of 380-730 nanometers onto a solid surface, collects the visible spectrum of reflection and records it digitally for comparison with the real reference sample.
67 It correctly identified 40 of 41. (98%)
Of the samples of erectile dysfunction drugs, 35 were forged.
However, when testing real samples, 25% of packages and 15% of tablets were mistakenly identified as forgeries.
Other physical properties of refraction method can be used to quantitatively detect the raw drug in solution by comparing the measured concentration with the concentration curve constructed by known standards.
AR200 digital refractometer when testing whether API is in the range of 80% to 120% of the prescribed concentration(
Lycra Microsystems Inc.
The sensitivity and specificity of 458 samples of 5 different antimalarial drugs were 83% - 100% and 56% - 87%. (
Tablets and injections).
68 false drug index(CoDI)
The ratio of laser intensity emitted and scattered by the drug was measured, and the results of the test sample were compared with those of the real drug.
The device correctly identifies 6 forgeries and 12 real artemether. -
Lumefantrine.
65 Handheld SOC-410 (
Surface Optics Corporation)
Analysis of Central Surface of Tablets by Directional Hemispheric Reflection Method-
Infrared and Near Infrared-
The infrared range does not require complex spectral interpretation.
One real and four counterfeit Viagra samples were identified 100% accurately.
A hand-held glossimeter based on Diffractive Optical Elements (DOEs) was developed. The difference of mirror glossiness between positive and false surfaces was analyzed.
The results of the device are consistent with those of the two methods. -
Screening of Two Kinds of Pseudo-Ether Size Glossimeter and Optical Interferometric Profiler-
Lumefantrine sample from Ghana.
70 Rapid Varieties for Microbial Contamination Detection(Bactest)
A portable respirometer detects pressure changes as a representative of microbial growth to detect contamination in liquid samples with a sensitivity of 93.
Under various laboratory conditions, 0% to 100% and 100% specificity of sterile water samples for injection were identified to determine the contamination of E. coli to microorganisms.
The characteristics of artesunate and oxytocin for injection products are correct because of the presence/absence of E microbial contamination.
Escherichia coli and Pseudomonas aeruginosa.
Further evaluating the field practicability of the equipment(
Not its performance)
The results show that although the device can generate results in uncontrolled field settings(
India and Zimbabwe)
The requirement of continuous power supply in the process of analysis(
It may take more than a day)
It may be an obstacle to its use in remote settings(table 2).
71 Formula Screening Equipment The equipment in this section checks the chemical \"fingerprints\" of the formula. both API(s)and excipients)
And classify them according to whether quantitative API analysis ability test has been carried out or not.
The ability of these devices to distinguish between the poor and the good-
The quality of drugs and the quantification of APIs depend not only on the performance of equipment, but also on the collection and post-processing of spectral data by relevant software.
They all need spectral reference libraries, but usually do not require them. -
It is destructive and does not require consumables.
Whether the testing equipment is capable of quantitative analysis of API. As far as we know, there is no built-in software to provide quantitative analysis of API.
The performance results of the quantitative capabilities of the devices described in this section are obtained after data processing in the laboratory.
Raman Truscan Room(
Thermodynamics)
Is it one of the six devices tested on site? (table 2).
It distinguishes 14 pools(
Counterfeit and degradable drugs)
Seventy genuine antimalarials are 100% sensitive and 99% specific. 15 Forty-
Four forged samples(
Eight different products)
And 62 genuine formulations(
Undeclared APIs, a total of 33 \"product lines\"
The accuracy is 100%.
16. Truscan exhibits similar matching/failure performance in drug identification. (
Although the signal resolution is low)
Compared with Raman desktop instrument.
16-18 View this table: View the main features and performance results of the inline view pop-up 2 field-
After sample preparation, 14 Viagra samples were tested with special reagents in mail facilities. (
12 Containing sildenafil)
With the truss RM, the accuracy is 91.
7% Qualitative Identification of Sildenafil(
Fourier transform-Infrared (FT-IR)
Analysis as a Reference Technology).
19 different advantages(
Simulated \"substandard\" drugs
In the same APIs and brands, matching/mismatching is not a reliable way to distinguish. -match approach.
In addition, a third of the placebos passed the accreditation test by mistake, rather than the API strength test.
16 in P-Value Survey(
Sample threshold limits for \"pass\" or \"fail\"
Five products containing candesartan were scanned by TruScan rm, and the P value could be set to 0. 40 (instead of 0. 05)
In order to better distinguish the substandard drugs whose content of APIs is less than 50% or more from the drugs. -
High quality products.
However, considering the small sample size, these results should be taken with caution.
First defender Traska(
Replaced by TruScan rm)
The number of APIs has been determined to be less than 1.
The reference contents of acetylsalicylic acid, ascorbic acid and caffeine were 6%-12%.
22 Mega Euro Real-time Raman Analyser(MIRA, Metrohm)
Identification of Adriamycin Injected in Different Concentrations(n=90)
Epirubicin(n=90)
Through glass containers, it has 100% sensitivity and specificity.
Quantitative determination of coefficients(r2)of 0. It is reported that there are 99 people. 23The EZRaman-I (TSI)
By using the Raman binary bar code method containing the reference library of API Raman spectra, the APIs in four pharmaceutical products containing amoxicillin, acyclovir and doxycycline 24 were qualitatively identified.
25. Ezraman predicts the results of the percentage of APIs claimed on an average of five labels per sample. -
I\'m within 3% of the high performance liquid chromatography results for three quarters of the products, and one of them has a value of 6.
It is 0% lower than that of high performance liquid chromatography.
Among 14 infrared-based devices(IR)/Mid-Infrared (Mid-IR)
Miniature Thermal Infrared(
Its predecessor was Fazil.
Small samples of different types of APIs or finished products were tested in the laboratory.
The spectral data of 2226-33 have been successfully obtained by using transparent blister packaging of six experimental samples.
Quantitative results of acetylsalicylic acid, ascorbic acid and caffeine in 28 tablets were similar to those of reference Fourier transform. -Near-Infrared (FT-NIR)instrument. 22. Trace Elements(
JDSU, then Viavi)
And TruDefender FT(
Thermodynamics)
It has been used to quantify API to less than 0. 1%–7.
8% of the references were used for weight loss and erectile dysfunction drugs, as well as acetylsalicylic acid, ascorbic acid and caffeine. 22 34The SCiO (
Consumer Physics)
The device has 100% specificity and sensitivity for the identification of counterfeits. (n=42)
With the Real(n=54)
The content of amodiquine in the antimalarial drug but not in the energetic product.
The device can be used to determine 95% artesunate in 15 kinds of oral products.
35 miniature desktop QDA single quadrupole mass spectrometer(Waters)
Correct identification of artemisinin-
Basic combination therapy(ACT)
Counterfeit antimalarial drugs were seized in 192 countries, including artemether + lumifendine and other compounds, such as chloramphenicol, ciprofloxacin and sugar.
The relative strength of each compound detected can be compared successively between tablets and used as an API quantitative agent.
For quantitative analysis, it has been proved that hand-held micro-10 mass spectrometer can produce parts. -per-
The one billion test limits for drug abuse are 37, but fecal drugs have not yet been assessed.
Devices with untried potential for quantitative analysis of free Raman devices. (MiniRam II (B&W Tek)
Raman RxN1 microprobe(Kaiser Optical)
And Ezraman M analyzer(
Electron wave electronics))
26 38 39 and around 9-infrared/mid-
Infrared equipment(
Multifunctional analyzer(Bruker Optics)Brightness 5030(Brimrose), RxSpec 700Z (ASD), Exoscan (A2 technology), MLp (A2 technology), FT/IR-4100 (JASCO), Cary 630 (Agilent)Nicole is 10(
Thermodynamics)
Target Mixed Analyser(
Thermodynamics))
Included in small-
Scale laboratory research.
Note 26 29 30 40 41, CBEX(Metrohm Raman)
The presence of paracetamol, amoxicillin, rumefenadine and pyrazinamide in various APIs/APIs combinations has been successfully identified, but no other fixed APIs have been identified. -
Drug combination, (
For example, artemether in artemether-
Lumefantrine film)
And furosemide and oxytocin in single API injection samples.
42 According to the API and degradation degree/type, a limited group of artificial degradation samples were accurately identified.
Field assessment of the utility of the equipment, not its performance. (table 2)
The proposal was also made by 10 operators with various technical experience from Indian and Zimbabwean regulatory authorities. -
Operating equipment requires less than two weeks of training. 42The NanoRam (B&W Tek)
It showed 100% sensitivity and 96% specificity. (
For TLC, samples were confirmed by high performance liquid chromatography, but TLC failed.
Investigation of 289 antimalarial samples(
Including 24 counterfeit and 22 experimental \"false API counterfeits\" containing paracetamol. .
4344A prototype nuclear quadrupole resonance(NQR)
The device has been successfully applied to the identification of ampicillin in capsules and paracetamol in tablets.
At present, there is no data report on its sensitivity and specificity.
45. Is the test equipment capable of quantitative analysis of API? As far as we know, there is no built-in software to provide quantitative analysis of API.
The performance results of the quantitative capabilities of the devices described in this section are obtained after data processing in the laboratory.
Raman Truscan Room(
Thermodynamics)
Is it one of the six devices tested on site? (table 2).
It distinguishes 14 pools(
Counterfeit and degradable drugs)
Seventy genuine antimalarials are 100% sensitive and 99% specific. 15 Forty-
Four forged samples(
Eight different products)
And 62 genuine formulations(
Undeclared APIs, a total of 33 \"product lines\"
The accuracy is 100%.
16. Truscan exhibits similar matching/failure performance in drug identification. (
Although the signal resolution is low)
Compared with Raman desktop instrument.
16-18 View this table: View the main features and performance results of the inline view pop-up 2 field-
After sample preparation, 14 Viagra samples were tested with special reagents in mail facilities. (
12 Containing sildenafil)
With the truss RM, the accuracy is 91.
7% Qualitative Identification of Sildenafil(
Fourier transform-Infrared (FT-IR)
Analysis as a Reference Technology).
19 different advantages(
Simulated \"substandard\" drugs
In the same APIs and brands, matching/mismatching is not a reliable way to distinguish. -match approach.
In addition, a third of the placebos passed the accreditation test by mistake, rather than the API strength test.
16 in P-Value Survey(
Sample threshold limits for \"pass\" or \"fail\"
Five products containing candesartan were scanned by TruScan rm, and the P value could be set to 0. 40 (instead of 0. 05)
In order to better distinguish the substandard drugs whose content of APIs is less than 50% or more from the drugs. -
High quality products.
However, considering the small sample size, these results should be taken with caution.
First defender Traska(
Replaced by TruScan rm)
The number of APIs has been determined to be less than 1.
The reference contents of acetylsalicylic acid, ascorbic acid and caffeine were 6%-12%.
22 Mega Euro Real-time Raman Analyser(MIRA, Metrohm)
Identification of Adriamycin Injected in Different Concentrations(n=90)
Epirubicin(n=90)
Through glass containers, it has 100% sensitivity and specificity.
Quantitative determination of coefficients(r2)of 0. It is reported that there are 99 people. 23The EZRaman-I (TSI)
By using the Raman binary bar code method containing the reference library of API Raman spectra, the APIs in four pharmaceutical products containing amoxicillin, acyclovir and doxycycline 24 were qualitatively identified.
25. Ezraman predicts the results of the percentage of APIs claimed on an average of five labels per sample. -
I\'m within 3% of the high performance liquid chromatography results for three quarters of the products, and one of them has a value of 6.
It is 0% lower than that of high performance liquid chromatography.
Among 14 infrared-based devices(IR)/Mid-Infrared (Mid-IR)
Miniature Thermal Infrared(
Its predecessor was Fazil.
Small samples of different types of APIs or finished products were tested in the laboratory.
The spectral data of 2226-33 have been successfully obtained by using transparent blister packaging of six experimental samples.
Quantitative results of acetylsalicylic acid, ascorbic acid and caffeine in 28 tablets were similar to those of reference Fourier transform. -Near-Infrared (FT-NIR)instrument. 22. Trace Elements(
JDSU, then Viavi)
And TruDefender FT(
Thermodynamics)
It has been used to quantify API to less than 0. 1%–7.
8% of the references were used for weight loss and erectile dysfunction drugs, as well as acetylsalicylic acid, ascorbic acid and caffeine. 22 34The SCiO (
Consumer Physics)
The device has 100% specificity and sensitivity for the identification of counterfeits. (n=42)
With the Real(n=54)
The content of amodiquine in the antimalarial drug but not in the energetic product.
The device can be used to determine 95% artesunate in 15 kinds of oral products.
35 miniature desktop QDA single quadrupole mass spectrometer(Waters)
Correct identification of artemisinin-
Basic combination therapy(ACT)
Counterfeit antimalarial drugs were seized in 192 countries, including artemether + lumifendine and other compounds, such as chloramphenicol, ciprofloxacin and sugar.
The relative strength of each compound detected can be compared successively between tablets and used as an API quantitative agent.
For quantitative analysis, it has been proved that hand-held micro-10 mass spectrometer can produce parts. -per-
The one billion test limits for drug abuse are 37, but fecal drugs have not yet been assessed.
Devices with untried potential for quantitative analysis of free Raman devices. (MiniRam II (B&W Tek)
Raman RxN1 microprobe(Kaiser Optical)
And Ezraman M analyzer(
Electron wave electronics))
26 38 39 and around 9-infrared/mid-
Infrared equipment(
Multifunctional analyzer(Bruker Optics)Brightness 5030(Brimrose), RxSpec 700Z (ASD), Exoscan (A2 technology), MLp (A2 technology), FT/IR-4100 (JASCO), Cary 630 (Agilent)Nicole is 10(
Thermodynamics)
Target Mixed Analyser(
Thermodynamics))
Included in small-
Scale laboratory research.
Note 26 29 30 40 41, CBEX(Metrohm Raman)
The presence of paracetamol, amoxicillin, rumefenadine and pyrazinamide in various APIs/APIs combinations has been successfully identified, but no other fixed APIs have been identified. -
Drug combination, (
For example, artemether in artemether-
Lumefantrine film)
And furosemide and oxytocin in single API injection samples.
42 According to the API and degradation degree/type, a limited group of artificial degradation samples were accurately identified.
Field assessment of the utility of the equipment, not its performance. (table 2)
The proposal was also made by 10 operators with various technical experience from Indian and Zimbabwean regulatory authorities. -
Operating equipment requires less than two weeks of training. 42The NanoRam (B&W Tek)
It showed 100% sensitivity and 96% specificity. (
For TLC, samples were confirmed by high performance liquid chromatography, but TLC failed.
Investigation of 289 antimalarial samples(
Including 24 counterfeit and 22 experimental \"false API counterfeits\" containing paracetamol. .
4344A prototype nuclear quadrupole resonance(NQR)
The device has been successfully applied to the identification of ampicillin in capsules and paracetamol in tablets.
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