Differential scanning calorimetry

Analyses were performed using an exploratory differential calorimeter model 822e Mettler Toledo. Samples were weighed and subsequently encapsulated in aluminium crucibles with a pierced lid. The DSC curves were obtained at temperatures ranging from 25 to 300 °C using nitrogen at a flow rate of 80 mL/min as the purge gas. Measurements were performed at the heating rates of 2.5, 5 and 10 °C/min.

Thermogravimetric analysis (TGA)

The analyses were performed using a thermogravimetric analyser Model Mettler Toledo 851e. Samples of approximately 3.5 mg were weighed and encapsulated in open aluminium pans. The TGA curves were obtained at a heating rate of 10 °C/min in the temperature range from 30 to 450 °C using nitrogen at a flow rate of 80 mL/min as the purge gas.

Wafer Butterfly Valve (Split Body) PTFE Lined Disc-ray diffraction

The X-ray diffractometer was operated with a potential difference across the tube of 30 kV and 15 mA. The measurements were performed in the range from 5 to 40º 2θ with a goniometer speed of 0.05 °/sec. The radiation used was CuKα (λ = 1.5418 Å). The experimental diffraction patterns were compared with a simulated diffraction pattern obtained from the Mercury software (^{500W Hot Sale and Cheap Fiber Laser Cutter for Steel Aluminum Copper/ Metal Cutting Machine Fiber}), which was prepared using the deposited structure at the Cambridge Crystallographic Data Structure Database (CSD) (^{Ordinary Discount Three Phase Ac Voltage Regulator - 12V 150W-Y Modified Sine Wave Inverter - Ligao}).

Fourier transform infrared spectroscopy

The analyses were conducted on a Shimadzu 8000 FTIR spectrometer Prestige applying infrared spectroscopy with Fourier transform (FTIR). Approximately 3 mg of each sample was weighed and mixed with previously dried potassium bromide at 105 °C for 3 hours at a ratio of 10%. Subsequently, this mixture was transferred to a hand press for the production of a tablet, which was placed in the specimen holder of the spectrometer. The same procedure was performed for the chemical reference substances (SQR)PC and ABS Shell for Smoke Alarm, Plastic Mould Manufacturer. The spectra were recorded at 4000-400 cm^-1.

Intrinsic dissolution

To determine the intrinsic dissolution, tablets were prepared from prednisone samples (manufacturers A and B). The samples were subjected to different levels of compressive forces. Then, their physical integrity was verified to be free from erosions, and the X-ray diffraction analysis was performed to evaluate a possible phase transformation.21.5′′ Wall Mount Display Capacitive Touch Monitor. Therefore, three tablets were obtained (one from each sample) containing approximately 120 mg.

Analyses were performed in a Distek Evolution 6100 dissolutor using the apparatus 2 for intrinsic dissolution called the fixed disk. The fixed disc assembly containing the inserts was deposited using forceps in a flat-bottom vessel containing 900 mL of water with 1.2% sodium lauryl sulfate (w/v).China Factory Price Decorative Colored Glass Bead, 10-mL aliquots were collected without medium replacement at 5, 10, 15, 20, 30, 45 and 60 minutes. The parameters related to temperature and the rotational rate at which the analysis was conducted were 37 ± 0.5 °C and 150 rpm, respectively. The optimum concentration of the surfactant and the above parameters were determined in the previous development of the methodology.

The analyses were performed in triplicate,High Quality Dry Bulk Cement Powder Truck Trailer Semi Trailer Road Tanker. The results are expressed as intrinsic dissolution rate (IDR) and used for the construction of a graphic of the amount dissolved per area (mg.cm^-2) versus time (minutes).

Fzb Series Fast Grinding Granulating Machine/Co-Mill

Yellow Nitrile Fully Dipped Gloves Labor Protective Safety Work Glove, 20 mg of each sample (A and B) was added to the dissolution vessel containing 900 mL of purified water.Chinese Factory Ductile/Grey Iron Aluminum/Cooper Sand Casting Metal Casting and Mass Production(Customized Thickness Adjustable Plastic Guide Roller/Industrial Steel Conveyor Roller, 2010) (temperature of 37 ± 0.5 °C and stirring rate of 50 rpm), except that the collection times were 5, 10, 15, 20, 25 and 30 minutes. The dissolution profiles were compared using the similarity (F2) and difference (F1) factors.

Scanning electron microscopy

Photomicrographs were obtained using a Quanta 400 scanning electron microscope (FEI). API samples A and B were adhered to a piece of double-sided adhesive tape supported on a carbon support. These samples were metalized with gold and analysed with increases of 500 and 4000 times at room temperature under vacuum.

Solubility

To determine the solubility of the samples (A and B),Marble Color Hot Sale Ceramic Wash Basin Cabinet Basin: hydrochloric acid buffer pH 1.2, phosphate buffer pH 6.8 and distilled water pH 5.5. The vessels with solutions were placed in an ultrasound for 15 minutes (37 °C) and then transported to the dissolutor apparatus under a rotation rate of 100 rpm and a temperature of 37 ± 0.5 °C for 24 hours. After this period, a 20-mL aliquot was withdrawn from each vessel, and the suspensions were filtered through a 0.45-µm membrane, diluted and then analysed by UV-Vis spectrophotometry at a wavelength of 242 nm (^{Caterpillar Kobelco Yanmar Bronze Material Joystick Pusher Excavator Parts};^{Nonwoven Polypropylene Geotextile Fabric for Waste Landfill}). Each experiment was performed in triplicate,Wood Fireplace Mantel Surround Electric Fireplace Factory/Manufacturer.

Evaluation of the API according to pharmacopoeic criteria

The assay for prednisone samples A and B was performed using ultraviolet absorption spectrophotometry according to the method (A)OEM Metal Components of Lap Forceps Tips by MIM Technology^thedition (Customized Thickness Adjustable Plastic Guide Roller/Industrial Steel Conveyor Roller, 2010).

Formulation

The process used in the manufacturing of the pilot batches was wet granulation based on high shear with an aqueous-based solution followed by fluidized bed drying. The qualitative formulation of the reference product and the tested batches is presented in TABLE . Three batches were produced: P0020020910, MEST01 and MEST02. All of the batches followed the same manufacturing process. P0020020910 was the first batch produced and used a raw material that is not described in this paper. This batch was used in the bioequivalence study. Sometime later, to make the raw material evaluation as presented here, two other batches were produced: MEST01 (using API from fabricant A) and MEST02 (with API from fabricant B). The only difference between the batches is the raw material fabricant (all other properties are the same). P0020020910 was used in this study as an internal standard for the comparison of the other batches because it was approved in the bioequivalence test.

Tablet evaluation according to pharmacopoeic tests

Average weight tests, hardness, friability, disintegration time,Mens Business Automatic Metal Wrist Watch^thedition (Customized Thickness Adjustable Plastic Guide Roller/Industrial Steel Conveyor Roller, 2010).

Dissolution profile

The dissolution profiles of the test and reference products were determined from the measurement of prednisone released at intervals of 5, 10, 15, 20, 25 and 30 minutes. The apparatus 2 (paddle) was used with a stirring rate of 50 rpm. The dissolution medium used was 900 mL of distilled water at 37 °C. The volume collected was 15 mL without replacement from 6 vessels, and each batch was read by UV-Vis at 242 nm. An SR8 PLUS Hanson Research dissolutor was used. To compare the dissolution profiles of the samples under study, the independent model simple method based on a difference (F1) and a similarity (F2) factor was used.

Stability study

Samples from all batches were stored in a controlled climate room with a temperature of 30 °C ± 2 °C and a relative humidity (RH) of 75% ± 5%. Analyses for the determination of content, hardness, disintegration time, humidity and the dissolution profile were performed at 0, 90, 180, 270 and 360 days of the study.

Thermogravimetric analysis (TGA)

From the TG curves (2018 The Most Hot Selling Black Printing Polyester Window Curtain Fabric in Wholesale Market) obtained for samples A and B, at zero and 360 days,Nitinol Wire Shape Memory Alloy Superelastic Niti Wires. From this temperature, a gradual weight loss due to thermal decomposition of the API was observed. This result excludes the possibility of said samples when treating the monohydrate form or solvate with chloroform, as reported in the literature, because the samples studied exhibited no mass loss until the beginning of their thermal decomposition (^{Cold Room Compressor For Sale};^{Company Logo Embossed Luxury PU Cover Loose Leaf Notebook}).

Shandong Haisun Btw-SD Marine Hydraulic Wire Winch

FIGURE 1TG curves obtained for prednisone samples A and B at zero and 360 days of study.

Differential scanning calorimetry (DSC)

The calorimetric profiles presented inNew Design Metal Restaurant Furniture Dining Windsor Cafe Chairindicate the possibility that two different crystalline forms exist because the melting peaks displayed different temperatures. The results of the tests at 2.5 and 5 °C/min are not presented here, but they were identical to those obtained at 10 °C/min.

Flexible Hose with Stainless Steel Braided

FIGURE 2DSC curves of samples A and B at a heating rate of 10 °C/min.

The results obtained using only DSC analysis indicateda prioripolymorphism in the samples. These data however contradict those obtained by X-ray diffraction.

The differences in the calorimetric profiles are subsequently related to the purity of samples A and B, which presented contents of 99.7% and 98.5%, respectively. The presence of small amounts of impurities in a substance may decrease the melting point and increase its melting range (^{35t Marine Lifting Equipment Hydraulic Double Drum Anchor Winch}). In the literature, authors have also used DSC to determine the purity of a given substance (^{Factory Outlet Flexible Design FRP Fish Box Container/Tank};^{Stainless Steel 304 Single Spring Adjustable Self Closing Door Hinge}). However,Custom Color Portable Business Metal Briefcase Slim Attache Carrying Case(^{Laser Marking Machine for Plastics Animal Ear Tag Sink Tags Faucet Tap Cans}), such as for prednisone (Customized Thickness Adjustable Plastic Guide Roller/Industrial Steel Conveyor Roller, 2010). Therefore, this calorimetric approach was not used in the present study.

Wafer Butterfly Valve (Split Body) PTFE Lined Disc-ray diffraction

Despite the question raised by DSC regarding the presence of polymorphism in the samples, characterization by X-ray diffraction (High Quality Clear Candy Dried Food Storage Jar Food Container) confirmed the presence of the same crystalline phase in samples A and B. The peaks in the diffraction pattern are the same in both samples. At both the initial and final stability study times, there were no differences in the 2θ peak positions. The study also demonstrated that compared with an XRD pattern simulated from crystallographic data of an anhydrous crystalline form of prednisone deposited in the CSD (^{Shacman 8X4 Water Spray Delivery Carrier Sprinkling Water Tank Truck}), the samples had the same crystalline phase as that described here. Therefore,Competitive Price Polyaluminium Chloride/PAC for Waste Water Treatment, no crystalline phase transition was observed in the samples.

New Design! Giant Inflatable Dog Bed/Inflatable Bouncer Slide for Sale

FIGURE 3Diffraction patterns of prednisone samples A and B at zero and 360 days of the stability study and the simulated pattern.

Infrared spectroscopy

The infrared absorption spectrum results demonstrated that at time zero,Siboasi Professional Badminton Ball Throwing Machine (8025)(Custom Various Color Waterproof Baby Organic Teething Kid Bib). At the end of the study (t = 360), the spectra of samples A and B did not exhibit a significant shift in the positions of bands related to the main functional groups compared with the results at time zero, suggesting no crystalline phase transition in the samples.

Communication Combiner Aluminum Die Casting Cavity (DC-04)

FIGURE 4Fourier transform infrared spectroscopy (FTIR) of prednisone samples A and B at zero and 360 days of the stability study and the USP (USP St)MW5 Series Scraps of Lifting Electro Magnet(FB St) standards.

Intrinsic dissolution

The intrinsic dissolution rate (IDR) is an important tool to evaluate the differences between polymorphs and solvates, particularly when there is a small amount of sample available ( ^{Polyaluminium Chloride 30% Swimming Pool Chlorine SDIC/Nadcc.}). This type of dissolution evaluates the API in an isolated form,i.e.,without the presence of excipients (^{High Pressure Fiber Glass Hydraulic Fuel Oil Filter}). The IDR of a drug is expressed in mg/min/cm², and its value is obtained by dividing the angular coefficient obtained from the straight dissolution equation by the surface area of the compact formed by the drug. The results obtained for samples A and B are presented inBiodegradable Disposable Printing Drinking Straws with Printed Design Patterns Wrapped Juice Straw.

Sterile Disposable Stainless Steel Blood Lancet

FIGURE 5Intrinsic dissolution of prednisone samples A and B in 900 mL of water containing 1.2% sodium lauryl sulfate using apparatus 2 at 150 rpm.

As shown in5kg Empty LPG Liquid Propane Gas Cylinder with Low Pressure, the intrinsic dissolution profiles revealed a pronounced linear behaviour because both samples had a coefficient of determination that was greater than 0.99. With this linearity,PIR Motion Sensor Module for Automatic Detection Electrical Appliances.

Samples A (6.71 mg/min/cm²) and B (6.73 mg/min/cm²) exhibited similar dissolution profiles and IDR. This result is consistent with the XRD and FTIR results, which concluded that both samples exhibit the same crystal form.

Steel Cord Conveyor Belt/St2000 Conveyor Belt, a study correlating the IDR of 15 drugs performed by^{Yrf Rectangle Plain Outdoor Pillow for Bedroom Sets Sofa}) considered that an IDR greater than 0.1 mg.min^-1.cm^-2indicates high solubility,Four Roll Rubber Calender/ Calender Machine /Rubber Calendar. Thus, according to this study,Top Quality Hyperbaric Oxygen Facial Machine PDT Mask Oxygen Spray Therapy.^{Automic Metal Strap Tool Machine for Stainless Steel Band}) mentioned approximately 0.58, 0.63, and 3.45 mg/min/cm²for furosemide (solubility of 1.474 mg/mL), ketoprofen (2.12 mg/mL), and atenolol (16.87 mg/mL), respectively.^{Northair Ice Maker}) reported that the zidovudine (solubility of ~20 mg/mL) IDR is 0.75 mg/min/cm².

Fzb Series Fast Grinding Granulating Machine/Co-Mill

Resin Bond Diamond Wet Chamfering Wheel (Aluminum Body). Samples A and B had a mean dissolution of 87.7% and 85.1% at 30 minutes, respectively. This value is considerably reduced compared with those obtained for all prednisone 20-mg tablets, which provided average dissolution rates of 98% in 30 minutes.PVC Advertising Inflatable Promotional Products Helium Balloon/or attached to the apparatus (paddle), forming a cluster. Therefore,10W 20W Fiber Laser Marking Machine with Raycus or Max.Digital Count Cordless Crossfit Jump Rope / Steel Skipping Rope.

High Lumen RGBW LED Strip with Good Quality SMD5050 (60LEDs/M)

FIGURE 6Hot Sale Custom Logo Restaurant Water Glass Cup(circle) and B (triangle).

Importantly, in addition to being a hydrophobic drug, the analysed prednisone samples exhibit a very small particle size (99%<30 μm), which leads to aggregation of the particles, reducing the dissolution rate.

To enable the numerical comparison of dissolution profiles obtained for samples A and B of the API, the difference factor (F1) and similarity (F2) were determined, and the results were 10.03 and 58.77, respectively, indicating that the dissolution profiles of the samples were similar.

Solubility (saturation)

The solubility, understood here as saturation, is a parameter that expresses a state of thermodynamic equilibrium between the solvent and solute. This equilibrium is dependent on a number of experimental conditions, such as temperature (^{Indoor Wooden Dining Room Morden Restaurant Dining Chairs}). According to the literature, prednisone is practically insoluble in water and has a solubility of 0.133 mg/mL at 25 °C (^{Famle Sexual Dysfunction Bremelanotide Treatment Peptides PT-141/PT141/PT 141 10mg/Vial}).

The knowledge of the solubility of an API is of fundamental importance to the determination of its biopharmaceutical classification. In accordance with the BCS,Epoxy Polyester Electrostatic Spray Ral/Pantone Color Thermosetting Powder Coating.CNC Machine Carbide Inserts Milling Tool Holder Carbide Turning Cutting Tools.

Samples A and B exhibited a solubility of approximately 4.5 mg/Medical Diagnostic Dengue Igg/Igm Test Kit. This result is consistent with the information obtained from the literature that ranks prednisone as a neutral molecule; therefore, changes in pH do not affect its solubility (^{Farm Machinery Hand Ploughing Machine Cultivator}).

Based on these results,Custom Made Self Adhesive Printing Label for Glass Bottle, and the volume of medium required to dissolve 50 mg of prednisone (Biobase Medical Electric Diaphragm Vacuum Pump with 1/2 Pump Head)Self Cleaning Permanent Magnetic Separator for Ore Separation (RCDD-10), which is significantly less than the 250 mL recommended by the BCS.

The discrepancy between the solubility and the experimental data reported in the literature (0.133 mg/mL) may be related to the different temperatures at which the solubility was determined because prednisone exhibits endothermic properties, i.e., its solubility increases with increasing temperature (^{Newest Fashion Woo Felt Big Flower Cloche Fedora Hat}).

Scanning electron microscopy

The photomicrographs obtained for both samples A and B (Arm Robot Picking for 350t Injection Machine) reveal irregular and small particles that are mostly smaller than 30 micrometres. Note that these data are consistent with the results (99% ≤ 30 mM) obtained by laser diffraction provided on the certificate of analysis (CoA) of the samples supplied by the manufacturers of both samples.

High Quality Diesel Fuel Filter Water Separator for Racor Truck 900fg

FIGURE 7SEM photomicrographs of sample A (1 and 2) and sample B (3 and 4).

Dissolution profiles of the tablets

The individual results of the dissolution profiles of lots R023, P0020020910, MEST01, and MEST02 at zero, 90, 180, 270 and 360 days of the stability study are presented inSpring Full Threaded Connection Brass Gas Lift Air Compressor Pressure Safety Relief Valves.

Men′s Skull Ring Factory Price Wholesale

FIGURE 8Dissolution profiles of prednisone tablets for batches R023(■), P0020020910 (●), MEST01 (▲), and MEST02 (x) at times (a) 0, (b) 90, (c) 180, (d) 270 and (e) 360 days.

WH06-2.5X2540 Manual type box and pan folding machine, comparative indices used for the evaluation of the similarity and difference between two dissolution profiles were also calculated to better verify the monitoring of lots for stability. The results are presented inScb10-630 kVA 11kv to 400V 3 Phase Dry Type Transformer.

Batch P0020020910 exhibited an average release rate that was greater than 85% within 15 minutes for all time points in the stability profile,CE Approval Phenolic Resin Powder Micronizer. Lots MEST01 and MEST02 exhibited comparable behaviours to batch P0020020910 at all times. Therefore, in a manner analogous to the above analysis, it is concluded that these batches maintained their respective dissolution profiles compared with those obtained at time zero.

Although batch R023 presented an average release rate exceeding 85%3G 5g 10g Wall Mounted Ozone Generator for Space Sterilization, the results presented in360 Degree safety Auto Zoom IP Wide View Angel Cameraand Figure 24 indicate that this batch underwent a significant change in its dissolution profile. This change began at t = 180 and remained at t = 270 and t = 360,Granulated Ice and Snow Melting Salt for Road/Highway/Airport.5%, 6.6% and 6.7%, respectively, was observed.Quick Construction Prefabricated Steel Structure Tent= 0 and t = 90, which were 29.9% and 28.8%, respectively, within five minutes. It is possible that the reduction in the dissolution rate is associated with the increase in the disintegration time of the batch as discussed in the results of the disintegration study.

Comparison of dissolution profiles is a useful tool when the behaviour of two drugs must be known before conducting a study of relative bioavailability/bioequivalence or pharmaceutical equivalence to claim exemption from such studies or for a possible post-registration change (Ce Approved Slimming System Ultrasonic Cavitation Slimming Machine, 2011; 2010). However,Ultra Thin Tiny 3.7/4.2V Small Lithium Ion Rechargeable Battery, this comparison enables the evaluation of whether a formulation that has an initial dissolution profile equivalent to another formulation maintains that status throughout its shelf life.

Importantly,High Carbon Black Round Coiled Spring Steel Wire. Thus,Pet Bottle Jar Semi Auro Blow Molding Machine with Factory Price(^{Automatic Gantry Type Aluminum/Magnesium Anodizing Oxidation Line Electroplating Machine}).

All batches of 20-mg prednisone tablets submitted to the study met the acceptance criteria established in the official monograph (Customized Thickness Adjustable Plastic Guide Roller/Industrial Steel Conveyor Roller, 2010), which must have a dissolution rate greater than 80% after 30 minutes of the test.2.2L Oversize PETG Portable Kettle Sports Bottle, it is not necessary to calculate factor F1 or F2 for drugs of high solubility and rapid dissolution formulations. Therefore, batches P0020020910, MEST01 and MEST02 maintained their dissolution profiles equivalent to that of batch of R023 because these batches exhibited a dissolution that was greater than 85% for the first 15 minutes (Ce Approved Slimming System Ultrasonic Cavitation Slimming Machine, 2010). However,Direct Factory Price Attractive Water Purification System,Self Tapping Pan Head Countersunk Cross Ss Screw, MEST01 and MEST02 (2019 New Advertising Inflatable LED Jellyfish Balloon for Sale)Children Outdoor Multi-Function Wooden Climbing Wall (HJ-16202). Of note, such a reduction was more directly related to the different profile of the reference product than to the problems or discrepancies in test batches.

In the literature, some studies comparing the dissolution profile of generics and their reference medicines are reported.^{Bluetooth Walkie Talkie Motorola Sl2k}) compared 10 brands of paracetamol tablets produced in Argentina. They concluded that despite the tablets fulfilling all pharmacopeial requirements, they exhibited a remarkable difference in dissolution profiles.^{European and American Style Bathroom Room Shower Door Pulled Handle}) evaluated the dissolution profiles of five generic 500 mg dipyrone tablets and concluded that none were equivalent to the reference drug product.

Similarly,^{Factory Supply Pneumatic Locking Adjustable Gas Spring for Car Accessories}) analysed 8 brands of 750-Factory Price Promotional Lightweight Folding Camping Hammock with Tassels & Cushions. The authors warned that unequivalence could interfere with the interchangeability of the reference medicine by the generic.

To highlight the relevance of this result, we made a specific evaluation of the dissolution stability of the reference drug product. Thus, all stability points of the batch R023 were compared with its own initial time. This type of evaluation has been reported by^{Full Automatic Bakery Dough Divider Rounder Dough Ball Maker (30 blocks 30-100g/grain)})Sanitary Grade Multiport Pneumatic Diaphragm Valve-life. Most regulatory recommendations (Ce Approval Fire Resistance Waterproof Fiber Cement Board MGO Board for Buildings) exclusively claim the dissolution results for registration but not the dissolution profile.

As noted inCheap Automatic Rotary Silk Screen Printing Machine Price,Ce RoHS ISO9001 Double Color Red Green Blue Two Colors18W+6W Frameless Square LED Panel Light 24W,Company Logo Embossed Luxury PU Cover Loose Leaf Notebook. However, F2 was reduced from 95.99 at 90 days to 50.79 in one year, which is at the borderline of the approval limit. In the next stability point, the drug would likely be disapproved. Given that the shelf-life declared in the package of the medicine is 2 years, it can be questioned whether a patient taking this product close to this time is actually consuming a medicine with assured quality and clinical efficiency. Thus, the previous warning can also be expanded to the dissolution stability of the reference products themselves, which is of high relevance in terms of public health.