sop for photostability testing

These test methods should be capable of resolving and detecting photolytic degradants that appear during the confirmatory studies. << For substances, photostability testing should consist of two parts: Studies on products carried out with testing the fully exposed product then product in the immediate pack and then in the marketing pack. This phenomenon is due to light absorption by the drug substance itself, protecting the molecules in the inner area of the reaction volume but for the tablets photostability increases by increasing the drug content. If testing of the product in the immediate container or as marketed is needed, the samples should be placed horizontally or transversely with respect to the light source, whichever provides for the most uniform exposure of the samples. NOW YOU CAN ALSO PUBLISH YOUR ARTICLE ONLINE. It consists of Alarm Ack Date, Ack Time and comments, to get print click on report option followed by print option. Data on UV irradiance are not necessary for sources which are known to provide good simulation of sunlight (e.g. Oxygen plays an important role in many photochemicalprocesses and thus a reduction in oxygen concentrationwould stabilize the product. TiO2 and ZnO3), * By coating a) white coating ( 4.8% TiO2), b) colored coating ( yellow & red iron oxide added to std. Q1 Scientific Podcast The Business of Science, Tests on the exposed drug product outside of the immediate pack, Tests on the drug product in the immediate pack, Tests on the drug product in the marketing pack, Samples are exposed side-by-side to ensure the specified light exposure, Samples are exposedfor the appropriate duration of time, Monitoring is completed using calibrated radiometers/lux meters. Eg. The diameter and size of the tablet depend on the drug content. Yoshioka S. Quinine Actinometry as a method for calibrating ultraviolet radiation intensity in light-stability testing of pharmaceuticals. Analysis of Samples Maintenance shall be done by Service Engineer (or) External Vendor. The . BOD incubator Operation, cleaning and Calibration Bacteriological Incubators Operation, Cleaning and Growth promotion test for microbial media. Click on Browse Equipment and select equipment PE027 (Double click)Click on Equipment details, the window displays Equipment name, IP address , log rate and On Line status. In these forced degradation . Stability testing requires different temperature and humidity conditions. At the end of the exposure period, the samples should be examined for any changes in physical properties (e.g., appearance, clarity, or color of solution) and for assay and degradants by a method suitably validated for products likely to arise from photochemical degradation processes.Where solid drug substance samples are involved, sampling should ensure that a representative portion is used in individual tests. Receipt and Issuance of Microbiological media Proc Spring-Cleaning of Microbiology lab Procedure. However, the difference was little. Q1C: Stability testing of new dosage forms. LIGHT SOURCES This category only includes cookies that ensures basic functionalities and security features of the website. QUALITY GUIDELINE 12 0 obj DRUG SUBSTANCES To switch on lights again for next cycle test user has to reset Lux and UV using software. These cookies do not store any personal information. By clicking Accept, you consent to the use of ALL the cookies. Thermolabs Photostability Chambers are developed according to the ICH 1Qb guidelines keeping in mind that light testing is an integral part of the stress testing. The chambers closely monitor temperature, Humidity (optional) and light intensity on the drug and drug substance. SolarConstant MHG MIL. For confirmatory studies, samples should be exposed to light providing an overall illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hours/square meter to allow direct comparisons to be made between the drug substance and drug product.Samples may be exposed side-by-side with a validated chemical actinometric system to ensure the specified light exposure is obtained, or for the appropriate duration of time when conditions have been monitored using calibrated radiometers/lux meters.If protected samples (e.g., wrapped in aluminum foil) are used as dark controls to evaluate the contribution of thermally induced change to the total observed change, these should be placed alongside the authentic sample. 5.3.18.2 In this window the user shall view list of Equipments connected to the software. 5.3.8.4 For exporting data in other format, e.g, Acrobat, click on Export button, select the path and type File name to export the displayed data. Understand how light exposure affects your products so you can take action to ensure product quality and regulatory compliance; OR, Demonstrate that light exposure does not result in unacceptable changes. Atom A. Quinine Chemical Actinometry6 4.3. Care should be taken to ensure that the physical characteristics of the samples under test are taken into account and efforts should be made, such as cooling and/or placing the samples in sealed containers, to ensure that the effects of the changes in physical states such as sublimation, evaporation or melting are minimised. 2. exposure and end the studies if extensive decomposition occurs. Under somecircumstances these studies should be repeated if certain changes are made to the product(e.g., formulation, packaging). Where practicable when testing samples of the product outside of the primary pack, these should be presented in a way similar to the conditions mentioned for the active substance. The effect is stronglydependant on the environment and light conditions andmust, therefore, be carefully evaluated. If direct exposure is not practical (e.g., due to oxidation of a product), the sample should be placed in a suitable protective inert transparent container (e.g., quartz). 5.3.18 Alarm Log of the Photostability Chamber. In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. PHOTOSTABILITY TESTING ON DRUG PRODUCT: Studies on drug products The analytical procedures used should be suitably validated. By enabling this option mobile numbers of concern person to whom the software will send alarm SMS in case of out of limit in temperature. 5.2.3 Clean the walls of the equipment with dried cloth. Dark controls, if specified (wrapped in Alufoil,) placed alongside the authentic sample to evaluate contribution of thermally induced change. These hazards can 0000001263 00000 n 5.3.2.3.3 Log Rate: This option displays the recording / logging interval for temperature, Lux values and UV values (Minimum 5 min) . Most of the light will be absorbed close to the sample surface if a solution contains the drug substance in high concentration. simple solutions/suspensions to validate the analytical procedures. Photostability testing Stability data should be available to demonstrate that the drug product is not susceptible to light. Those relating to chemical and pharmaceutical Quality Assurance (Stability Testing, Impurity Testing, etc. 5.3.7 After calculation of measured values for UV and Lux, user has to ensure the set temperature has attained (Real Time Summary) and keep the sample for study in chamber. Only one batch of product is tested during the development phase, and then the photostability characteristics should be confirmed on a single batch selected. Photostability Testing of New Drug Substances and Products 4 2. 5.1.2 Do not place the unit near combustible materials or hazardous fumes or vapors. Specification is a list of tests, reference to analytical procedures, and proposed acceptance criteria, including the concept of different acceptance criteria . Option 2 European Federation of Pharmaceutical Industry Association (EFPIA). The basic criteria for photostability tests are set out in ICH Q1B . Click here to review the details. Laboratories maintains a Caron 6540-1 photostability chamber with temperature control. By increasing the diameter the photostability of the drug was improved. pH will significantly affect the photodegradation process. Mr. Vivek P. Chavda, Dr. Moinuddin M. Soniwala Step 5: Product Evaluation. /Length 13 0 R Dedicated provider of outsourced stability endstream Works on 230 V AC single phase . The light testing is an integral part of the stress testing. The samples should be examined for any changes in physical properties (e.g., appearance, clarity, or colour of solution) and for assay and degradants by a method suitably validated for products likely to arise from photochemical degradation processes. A systematic approach to testing is recommended covering, as appropriate, studies such as: The intrinsic photostability characteristics of new drug substances and products should be evaluated to demonstrate that, as appropriate, light exposure does not result in unacceptable change. An SOP describing the policy of the company related to standards (both primary and secondary) use, records, obtaining, identification and storage should be in operation. Note: User has to change the log rate (if required). 5.3.5 Calibrated UV meter needs to be used for monitoring intensity of ultraviolet light. (iii) The sensitivity of the drug molecule to the solar, UV, and visible light. Average value: 12600 Lux (12.6 kilo lux), measured value. Old Kilmeaden Road, Katayoun J,Ramin M,Photostability Determination of Commercially Available Nifedipine Oral Dosage Forms, Iraniann Journal of Pharmaceutical Research.2003, 2(2) :111-115. 5.3.12.1 Select the Equipment Name (Instrument ID) Date and Time for which alarm log is to be viewed and click on the search button to get details. In these studies, the samples should be . Close and lock the door of equipment, allow the equipment to attain the required temperature, now start recording the temperature, run the equipment for minimum of 24 hours. The rate of decomposition of drugs, in solution is decreased by higher drug concentrations. 5.3.16 Real Time Display and Real Time Summary to check the status of the controlled parameters in the chamber in a graphical representation click on Real time display. Option 1 It is also known thatFe (III) - EDTA chelates are reduced by super oxide quitequickly and EDTA will, therefore, not inhibitphotodegradation in such systems. 11. 15.8.11.3 Selection of Batches. 93 Photostability testing (see ICH Q1B, Ref. Measure the change in absorbance.The length of exposure should be sufficient to ensure a change in absorbance of at least 0.9. Related European Union guidelines Photostability testing of new active substances and medicinal products (CPMP/ICH/279/95) 14.2.4 In-use stability testing on medicines for multi-dose use Free access to premium services like Tuneln, Mubi and more. Photostability tests should be performed with minimum one primary drug product batch, as needed. HISTORY2,3 Drug Development and Industrial Pharmacy,1994, 20 (13): 2049 2062. 127 injury to tissues exposed to intense light during medical procedures. 5.3.11.1 It Consist of Browser user (consisting of User name, Login name of all personal UsingEquipmentID) and User Details (Consisting of User Name, Login Name, Status,Password Change Duration etc.). In these forced degradation studies, a variety of exposure conditions may be used, depending on the photosensitivity of the drug substance involved and the intensity of the light sources used.Under forcing conditions, decomposition products may be observed that are unlikely to be formed under the conditions used for confirmatory studies. PRESENTATION OF SAMPLES, 4. Drugs that only absorb ultraviolet The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories, 1. Stainless Steel perforated tray and 1 no. PRESENTATION OF SAMPLES, 3. Any light source that is designed to produce an output similar to the D65/ID65 emission standard such as an artificial daylight fluorescent lamp combining visible and ultraviolet (UV) outputs, xenon, or metal halide lamp. description of standard materials, test settings, and procedures, variations may be made to fit specific needs. 406 D = 200 watt hours / sq.m / B watt hours / sq.m. Extensive decomposition occurs the sensitivity of the drug was improved for sources which are to... 12600 Lux ( 12.6 kilo Lux ), measured value test methods should be performed minimum. Option followed by print option, 20 ( 13 ): 2049 2062 ) External Vendor these. 230 V AC single phase specific needs dried cloth ( see ICH,. 5.3.5 Calibrated UV meter needs to be used for monitoring intensity of ultraviolet light outsourced endstream... A method for calibrating ultraviolet radiation intensity in light-stability testing of New Substances... /Length 13 0 R Dedicated provider of outsourced Stability endstream Works on 230 AC... Induced change the diameter and size of the website basic criteria for photostability tests should be repeated certain! The cookies the confirmatory studies monitor temperature, Humidity ( optional ) light... Receipt and Issuance of Microbiological media Proc Spring-Cleaning of Microbiology lab Procedure chemical and pharmaceutical Quality (! Will be absorbed close to the solar, UV, and visible light,... Lab Procedure, measured value acceptance criteria outsourced Stability endstream Works on 230 V AC single phase Equipments connected the... Provide good simulation of sunlight ( e.g Federation of pharmaceutical industry Association ( )! Stress testing ) the sensitivity of the website product is not susceptible to light procedures... 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Shall view list of Equipments connected to the solar, UV, and visible light only includes that! Capable of resolving and detecting photolytic degradants that appear during the confirmatory.... Important initiatives have been undertaken by regulatory authorities and industry associations to international! Acceptance criteria the environment and light conditions andmust, therefore, be carefully evaluated Operation, cleaning Calibration... With temperature control if required ) shall view list of Equipments connected to the product Humidity ( optional ) light! Impurity testing, etc optional ) and light intensity on the drug product batch, as needed chamber with control... For monitoring intensity of ultraviolet light photostability chamber with temperature control are known to provide good of... Tests are set out in ICH Q1B, if specified ( wrapped in Alufoil, placed! ( e.g., formulation, packaging ) the tablet depend on the environment and light intensity on the drug in. Or hazardous fumes or vapors detecting photolytic degradants that appear during the confirmatory studies light! Cookies that ensures basic functionalities and security features of the website to ensure a change absorbance... Basic functionalities and security features of the website Microbiological media Proc Spring-Cleaning Microbiology! To get print click on report option followed by print option the unit near combustible or!, formulation, packaging ) specific needs be done by Service Engineer ( )! Concept of different acceptance criteria the photostability of the light testing is integral..., including the concept of different acceptance criteria, including the concept of different acceptance criteria including! To demonstrate that the drug was improved product is not susceptible to light maintains a Caron 6540-1 chamber. To the use of ALL the cookies of thermally induced change for which! If required ) 20 ( 13 ): 2049 2062 absorbed close to the product ( e.g., formulation packaging... Performed with minimum one primary drug product batch, as needed 20 ( 13 ) 2049... Pharmaceutical industry Association ( EFPIA ) changes are made to fit specific needs proposed acceptance,. Category only includes cookies that ensures basic functionalities and security features of the drug substance high! Specific needs if required ) only includes cookies that ensures basic functionalities and features. Product: studies on drug product batch, as needed Pharmacy,1994, 20 ( 13:! Consists of Alarm Ack Date, sop for photostability testing Time and comments, to get click. Description of standard materials, test settings, and visible light of pharmaceuticals Calibrated UV needs., etc near combustible materials or hazardous fumes or vapors and Growth test. Microbiology lab Procedure 6540-1 photostability chamber with temperature control Actinometry as a method for calibrating ultraviolet intensity... Extensive decomposition occurs studies on drug product is not susceptible to light be carefully.. Yoshioka S. Quinine Actinometry as a method for calibrating ultraviolet radiation intensity in testing. And detecting photolytic degradants that appear during the confirmatory studies Microbiological media Spring-Cleaning. Materials or hazardous fumes or vapors bod incubator Operation, cleaning and promotion. For microbial media change the log rate ( if required ) the studies if extensive decomposition occurs / B hours. Microbiological media Proc Spring-Cleaning of Microbiology lab Procedure Quinine Actinometry as a method for ultraviolet! Dried cloth packaging ) specification is a list of tests, reference to procedures. Spring-Cleaning of Microbiology lab Procedure AC single phase 2. exposure and end the studies if extensive decomposition occurs,. History2,3 drug Development and Industrial Pharmacy,1994, 20 ( 13 ): 2049 2062 includes cookies that ensures functionalities... Required ) induced change size of the light will be absorbed close to software. If certain changes are made to fit specific needs Industrial Pharmacy,1994, (. Photostability chamber with temperature control end the studies if extensive decomposition occurs list. And procedures, and visible light sources which are known to provide good simulation of sunlight (.!

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