INTRODUCTION:

Since quality is a wide concept, it should be incorporated into the product rather than tested.^1,2 Pharmaceutical production quality has become a sensitive and important topic. The Food and Drug Administration's (FDA) adoption of current good manufacturing practices (cGMP) for the twenty-first century, along with the global community's efforts to integrate its practices and guidelines, has increased awareness of the impact of pharmaceutical quality. Only after the manufactured goods meet their defined quality traits and criteria are they deemed "fit for use".³

GMP refers to manufacturing procedures that produce high-quality final goods while taking employee safety into sufficient account. GMP addresses quality control (QC) as well as production.⁵ In order to eradicate errors at every level of production, QC staff evaluates the quality of all production-related components as part of GMP. By preventing or removing faults at every stage of manufacturing, quality control aims to create a flawless final product. The physical plant design, space, ventilation, cleanliness, and sanitation throughout regular manufacturing all have an impact on quality control, which is a team effort. It is important to keep in mind that quality must be incorporated into drug products during product and process design.⁶

It is necessary to carry out the quality control test as directed by different pharmacopoeias and guidelines in order to verify the quality of pharmaceutical dosage forms.^7-9 "The operational techniques and activities that are useful to fulfill requirements for quality" is how the International Standard of Organization (ISO) defines quality control. According to this definition, the quality control test may be used for any task pertaining to quality assurance, management, improvement, or control.⁷ In order to ensure that the starting materials, intermediates, packaging materials, and final pharmaceutical products meet approved specifications or standards for identity, strength, purity, and other attributes, quality control of medicinal products encompasses all actions taken, including the establishment of specifications, sampling, pertinent testing, and analytical clearance.^10,11 Quality control emphasizes checking products for flaws, which makes it easier for the manufacturer to reject product releases or conduct any necessary research to ensure that items are completely flawless before going on sale.^12,13

IPQC testing are conducted before the production process is finished at regular intervals. IPQC's role is to monitor and, if required, modify the manufacturing process in order to conform to pharmacopoeias. Materials used in manufacturing should undergo adequate identification, strength, quality, and purity testing before being accepted or rejected by the QC unit throughout production.^14-19 Quality control emphasizes checking products for flaws, which makes it easier for the manufacturer to reject product releases or conduct any necessary research to ensure that items are completely flawless before going on sale.¹³

IPQC testing are conducted before the production process is finished at regular intervals. IPQC's role is to monitor and, if required, modify the manufacturing process in order to conform to pharmacopoeias. While the production process is underway During the production process, materials should be authorized or rejected by the QC unit after being tested for identity, strength, quality, and purity as needed.^14-19 In order to stop their use in manufacturing, rejected in-process materials should be recognized and managed under a quarantine system.²⁰ Tests known as finished product controls (FPCs) are carried out after the manufacturing process is finished to verify both qualitative and quantitative attributes, as well as test protocols and their acceptable limits, which the final product must adhere to for the duration of its legal shelf life.¹³

Drug standards are pharmacopoeias.^21,22 Different pharmacopoeia around the world, including the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), and United States Pharmacopoeia (USP), have established the precise ranges that a value must lie within to meet the criteria. Showing the quality metrics for pharmaceutical tablets in accordance with pharmacopoeias that are a component of in-process and final product quality control testing is the aim of this study.

Standard tests for pharmaceutical tablet:^23-25

Tablets make up almost half of the market's dosage. The standard tests for pharmaceutical tablets are listed below. There are four tests.

Description:

This test contains a description of the tablet based on its outside look. Such a tablet may be spherical, white, biconvex, film-coated, and have the word "Rx" imprinted on one side. The description is qualitative.

Identification:

Verifying the identity of the active pharmaceutical ingredient (API) in a pharmaceutical tablet is the goal of an identification or identity test. It is anticipated that this test will be able to distinguish between molecules with roughly comparable structures.²⁶

Assay:

This test, often known as a content test, ascertains the potency or composition of the API in the medication tablet.

Impurities:

This test, which detects the presence of components other than API or excipients, is frequently referred to as a purity test and a stability-indicating test. Related substances that result from a chemical change in the drug substance that occurs during manufacturing and/or storage of the new drug product are the most common type of impurities that are calculated.^27,28

In-process and finished product quality control test for the tablet dosage form:

IPQC tests regulate the following physical characteristics of pharmaceutical tablets: temperature, pressure, moisture content, time, weight, particle size, hardness, drying loss, disintegration time, color, compactness, integrity, etc. Pharmaceutical tablet FPQC tests include assay, mass and content uniformity, weight fluctuation, friability, active component content, hardness, disintegration, and dissolution tests, among others. Pharmacopoeia-recommended IPQC and FPQC tests for pharmaceutical tablets are as follows:

Size and Shape:

The size and shape of the tablet should be according to need of the dose requirement and can be dimensionally described monitored and controlled. It is determined by the tooling during the compression processes.

Colour and odour:

Many medicinal tablets use color for identification purposes, and it also helps with consumer acceptance. However, it must be consistent from batch to batch, from tablet to tablet, and inside a single tablet. An odor in tablet batches, such as that of vitamins, may be a sign of a stability issue. The taste of the chewable tablet is a crucial component in determining consumer acceptance.

Unique Identification Markings:

In addition to color, pharmaceutical companies frequently add distinctive markings to tablets. These markings, which enable quick product identification, sometimes involve printing, engraving, or embossing the company name, symbol, or product code.²³

Thickness:

Thickness measurement is used to assess consistency in production processes such as granulation, particle size, size distribution, and powder mixing, among others.²³ It depends on the tooling used during the compression process (e.g., die diameter, die internal volume, powder compressibility, force or pressure, etc.). It is possible to use a micrometer or other automated equipment to determine the thickness of entity tablets.²⁶ The thickness of the tablet, which is measured in millimeters (mm), should be kept within a range of ± 5% departure of a standard to facilitate the packing process.²³

The moisture content of granules:

Granules in wet granulation are held together by bonds of a specific strength, primarily because of the moisture content of the particulate matter powder. Additionally, a certain percentage of moisture content affects the powder's flowability, compressibility, and size reduction. Granules that are overly dry, for instance, have a tendency to cap or laminate when tablets are compressed.⁹

Hardness:

Fig. 1: Monsanto Tester

Hardness influences the friability, solubility, and disintegration of tablets, making it a potentially important criterion. For tablets to survive abrasion during handling, packing, and transit, they must have a specific level of hardness and resistance to friability. The hardness of tablets is influenced by the granulation characteristic, which is the amount of pressure applied during compression. It is crucial to regulate pressure in order to regulate the hardness of a tablet. A multifunctional system, the Monsanto, Pfizer, Erweka, and Schleuniger hardness testers, or others are used to measure hardness.^23,26 In most cases, the tablets are placed between two platens, one of which is stationary while other movements exert sufficient force to shatter a tablet. Conventional and round tablets are loaded throughout their diameter (a diametrical loading) at the point where breakage occurs.³⁰ Crushing strength, which should be greater than 4kg, is typically measured by hardness (in kilograms, pounds, or other arbitrary units).²⁶

Content uniformity test:^31-33

A physically sound tablet may not produce the desired effects. To evaluate a tablet potential for efficacy, the amount of drug per tablet needs to be monitored from tablet to tablet and batch to batch. Content uniformity test is performed randomly on 10 individual tablet.

IP: Active less than 10mg or 10%

BP: Active less than 2mg or 2%

USP: Active less than 25mg or 25%

10 tablets limits NMT 1 tablet deviate 85 – 115% and none outside 75 – 125% of the average Value IP /BP/ USP (Relative standard deviation less than or equal to 6%) If 2 or 3 individual values are outside the limits 85 115% of the average value, and none outside 75 – 125% repeat for 20 tablet Complies when 30 tablets NMT 3 of the individual values are outside the limits 85 – 115% of the average values and none outside 75 – 125%.

Uniformity of Mass:

This test applies to concrete and uncoated panels. 20 tablets will be selected at random and individually weighted according to BP; to determine the average weight. To meet the requirements described in table 1, especially in the second quarter, the collective must adhere to one of the concessions and send the maximum measurement of two individual books from the average volume.

Table 1: BP limits for uniformity of mass:

Average Mass (mg)	Average Mass (mg)
80 or less	10
More then 80 or less then 250	7.5
250 or more	5

Weight Variation Test:

According to the USP this tablet is performed on 20 tablets by calculating the average weights and comparing with the individual tablet. The value of weight variation test is expressed in percentage. Formula for weight variation test

Weight Variation = (Iw - Aw)/Aw X 100%

Where,

Iw = Individual weight of tablet

Aw = Average weight of tablet.

As per USP the tablet complies with the test if not more than 2 of the individual masses deviate from the average mass by more than the percentage deviation as shown in Table 2 and none deviates by more than twice that percentage.

Table 2: limits for weight variation test as per IP, BP, USP^31-33

Average mass(mg)		Percent Deviation (%)
IP/BP	USP	Percent Deviation (%)
80mg or less	130mg or less	±10 %
More than 80mg or less than 250mg	130mg to 324mg	±7.5%
250mg or More	More than 324mg or More	± 5%

Content of Active Ingredients:

The purpose of carrying out these tests according to the International Pharmacopeia IP is to determine the amount of active substance using the described measurement method and to estimate the dose of the active substance. It's on every bill. Products must conform to the specified range of active ingredient content as indicated in the relevant literature. This range is determined by the need to use 20 tablets during use or other quantities specified in the monograph. If you don't have 20 frames, you can use as little as 5 or more frames. However, to account for possible sampling error, the allowed difference is extended as shown in Table 3.

Table 3: IP limits for content of active ingredients.

Weight of Active Ingredients in Each Tablet	Subtract from Lower Limit for Samples of			Add to the Upper Limit for Samples of
	15	10	5	15	10	5
0.12g or less	0.2	0.7	1.6	0.3	0.8	1.8
More than 0.12g but less than 0.3g	0.2	0.5	1.2	0.3	0.6	1.5
0.3g or more	0.1	0.2	0.8	0.2	0.4	0.8

As specified by the IP requirements Table 3 apply when the stated limits are between 90 and 110 %. For limits other than 90 to 110 percent, proportionately smaller or larger allowances should be made.

Assay:

An active ingredient, often known as an API, is found in tablets. Using an appropriate analytical technique, this test calculates the strength or content of the API that should be present in the pharmaceutical tablet based on the strength listed on the label.^28,29 The average of each individual's content uniformity—which adheres to the comparable analytical process outlined in the assay test with appropriate adjustments made for variations in sample preparation—is frequently used to compute the assay value.²⁷

Friability Test:

Friability of a tablet can determine in laboratory by Roche friabilator. For this test twenty tablets are weighed and placed in the friabilator and then operated at 25rpm for 4 minutes. The tablets are then dedusted and weighed. The difference in the two weights is used to calculate friability and the value of friability is expressed in percentage. It is calculated by the following formula:

Friability = (Iw – Fw)/ Iw x 100%

Where,

Iw = Total Initial weight of tablets

Fw = Total final weight of tablets.

Fig. 2: Friabilator

Disintegration Test:

Six three-inch-long glass tubes that are open at the top and supported by a 10-mesh screen at the basket rack assembly's bottom make up the USP disintegration equipment. One tablet is put in each tube to test the disintegration time, and the basket rack is set up in a specific medium at 37±2°C so that the tablet stays 2.5 cm below the liquid's surface as it rises and descends no closer than 2.5cm from the beaker's bottom. The basket assembly holding the tablets is moved up and down at a frequency of 28 to 32 cycles per minute using a typical motor-driven device over a distance of 5 to 6cm. The exam may also make use of perforated plastic discs. When placed on top of tablets, these give the tablets an abrasive effect. The discs work well for floating tablets. Unless otherwise permitted and justified, run the device for the allotted amount of time (15minutes for an uncoated tablet).²² If the tablets break apart and every particle makes it past the 10-mesh screen within the allotted time, the tablet passes the test. Any residue that is left over must have a soft bulk and no discernible rigid core. If all of the tablets have completely dissolved, the tablet passes the USP test. Do the test again with 12 more tablets if 1 or 2 don't dissolve fully. The requirement is met if not less than 16 of the total of 18 tablets tested are disintegrated.

Fig. 3: Disintegration Apparatus

The BP and IP limits for disintegration times of tablets are given in Table 4.³²

Table 4: Limits for disintegration times of tablets as per IP, BP, USP^31,32

Categories of tablets	Disintegration time (min)
Categories of tablets	IP (min)	BP (min)	USP
Uncoated tablets	15	15	5-30 min.
Coated tablets	60	60	1 – 2 hrs.
Enteric-coated tablets	60	-	1 hr or as per individual monograph
Film-coated tablets	30	-	30 min or as per individual monograph
Effervescent tablets	5	5	Less than 3 min or as per individual monograph
Soluble tablets	3	3	-
Dispersible tablets	3	3	Less than 3 min or as per individual monograph
Orodispersible tablets	-	3	-
Gastro-resistant tablets	-	60	-
Oral lyophilisates	-	3	-

DISSOLUTION:

The BP, USP dissolving apparatus I (Basket apparatus) and apparatus II (Paddle apparatus) are 1L transparent cylindrical vessels made of glass or plastic that have a hemispherical bottom that can be covered. The stirring element, where the paddle is utilized in apparatus II and the basket is used in apparatus I, is the only assembly difference between the two devices. This setup, however, is inverted in IP, where apparatus I uses a paddle, while apparatus II uses a basket. The temperature of the partially submerged vessel in a water bath is kept at 37±0.5°C during the test.^23,27,29 The specified volume of dissolving medium (±1%) is put in the vessel of the specific device to test dissolution, and the temperature is maintained at 37±0.5°C for the duration of the test. A single tablet is inserted into the apparatus, and after a predetermined amount of time, a sample is taken from halfway between the surface of the dissolving medium and the top of a spinning basket or paddle, at least 1 centimeter from the vessel wall, taking care to prevent air bubbles from forming on the tablet surface. Fresh dissolving media is used to replace the aliquots that were removed for the designated number of sampling periods. As specified in the individual monograph, the analysis was carried out using an appropriate dissolving media and assay technique, and the test was repeated using extra tablets. When using a buffered solution as a dissolving medium, the pH of the solution is adjusted to within 0.05 units of the specified pH.

In respective of time, the specimens are withdrawn within a tolerance of ±2% of the stated time

Fig. 4: Dissolution Apparatus

According to BP, IP, and USP, unless otherwise specified, the requirements are met if the quantities of active substance dissolved from the dosage units conform to table 5, 6, 7, and 8.^31-33

Table 5: Acceptance criteria for dissolution test of a tablet for immediate release tablets as per IP, BP, USP.

Stage	Number of tablets tested	Acceptance Criteria
S1	6	Each unit is not less than Q + 5 %.
S2	6	Average of 12 units (S1 + S2) is equal to or greater than Q, and no unit is less than Q – 15 %.
S3	12	Average of 24 units (S1 + S2 + S3) is equal to or greater than Q, not more than 2 units are less than Q – 15 % and no unit is less than Q – 25 %.

Table 6: Acceptance criteria for dissolution test (pooled sample) of a tablet for immediate release tablets as per USP.

Stage	Number of tablets tested	Acceptance Criteria
S1	6	Average amount dissolved is not less than Q + 10 %.
S2	6	Average amount dissolved of 12 units (S1 + S2) is equal to or greater than Q + 5 %.
S3	12	Average amount dissolved of 24 units (S1 + S2 + S3) is equal to or greater than Q.

Unless the results conform at either S1 orS2, continue testing through the 3 stages. The value Q (D in IP), is the specified quantity of dissolved active substance, expressed as a percentage of the labelled content.^31-33

Table 7: Acceptance criteria for dissolution test of a tablet for Extended or Prolonged-release tablets as per USP, BP, IP.

Stage	Number of tablets tested	Acceptance Criteria
L1	6	No individual value lies outside each of the stated ranges and no individual value is less than the stated amount at the final test time.
L2	6	The average value of the 12 units (L1 + L2) lies within each of the stated ranges and is not less than the stated amount at the final test time; none is more than 10 per cent of labelled content outside each of the stated ranges; none is more than 10 per cent of the labelled amount below the stated amount at the final test time.
L3	12	The average value of the 24 units (L1 + L2 + L3) lies within each of the stated ranges, and is not less than the stated amount at the final test time; not more than 2 of the 24 units are more than 10 per cent of labelled content outside each of the stated ranges; not more than 2 of the 24 units are more than 10 per cent of labelled content below the stated amount at the final test time, and none of the units is more than 20 per cent of labelled content outside each of the stated ranges or more than 20 per cent of labelled content below the stated amount at the final test time

Unless the results conform at either L1 or L2, continue testing through the three stages. Limits on the amounts of active substance dissolved are expressed in terms of the percentage of the labelled content. The limits embrace each value of Qi (D in IP), the amount dissolved at each specified partial dosing interval. Where more than one range is specified, the acceptance criteria apply individually to each range.^30,32

Table 8: Acceptance criteria for dissolution test of delayed-release or modified release tablet as per USP, BP and IP.

Acid Stage	Number of tablets tested	Acceptance Criteria
A1	6	No individual value exceeds 10% dissolved.
A2	6	Average value of 12 units (A1 + A2) is not greater than 10% dissolved, and no unit is greater than 25% dissolved.
A3	12	Average value of 24 units (A1 + A2 + A3) is not greater than 10% dissolved, and no unit is greater than 25% dissolved.
Buffer Stage	Number of tablets tested	Acceptance Criteria
B1	6	Each unit is not less than Q + 5 %.
B2	6	Average of 12 units (B1 + B2) is equal to or greater than Q, and no unit is less than Q – 15 %.
B3	12	Average of 24 units (B1 + B2 + B3) is equal to or greater than Q, not more than 2 units are less than Q – 15 %, and no unit is less than Q – 25 %.

Note: Unless otherwise specified, proceed the acid stage test and buffer stage test separately.

Unless the results conform at either A1 or A2 and B1 or B2, continue testing through the three stages. According to JP, when the value of Q or D is not specified in individual monograph and if 1 or 2 tablets fail to comply within the requirements as in both acid and buffer stage, repeat the test on additional six tablets. To conform to the test, not less than 10 tablets out of 12 should meet the requirements

CONCLUSION:

High-quality medications must meet the standards defined by the Pharmacopoeia. These guidelines are followed by around 140 sovereign nations, including national authorities and medical professionals from Africa, Europe, and other continents, according to the World Health Organization's (WHO) statistics. According to the review, there are minor variations between the British and United States pharmacopoeias, as well as between the IPQC and FPQC of the Indian pharmacopoeia. Certain pharmacopoeia do not give access to certain testing. The product's formulation must adhere to the specifications given in the relevant pharmacopoeia. For IPQC and FPQC testing, different pharmacopoeia establish different restrictions. The production of high-quality pharmaceuticals for human health is, nevertheless, the primary goal of all pharmacopoeias.

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