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\def\citeauthor{~Prathap~B,
              ~Ananth~K,
              ~Arthi~A,
              ~Arunagiri~A,
              ~Balaji~R}
\def\citetitle{Quality Control Test for Pharmaceutical Dosage Forms: A Review}
\def\copyrightstmt{This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial- ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.}
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\def\RunningAuthor{Prathap B et al.}
\firstPage{227}
\articleType{Review Article}
\receivedDate{15 Nov 2021}
\acceptedDate{03 Dec 2021}
\revisedDate{02 Dec 2021}
\journalVolume{1}
\journalIssue{4}
\journalDoi{fjphs.v1i4.205}
\copyrightYear{2021}
\eISSN{2583-116X}
\journalDoi{fjphs.v1i4.205}
\def\authorCount{5}
\def\affCount{2}

\def\journalTitle{Future Journal of Pharmaceuticals and Health Sciences}

\title{Quality Control Test for Pharmaceutical Dosage Forms: A Review}
\author{Prathap~B\textsuperscript{*}\textsuperscript{1}\textsuperscript{\href{https://orcid.org/0000-0001-9731-6252}{\XeTeXLinkBox{\includegraphics[height=7pt]{orcid-logo-pharmascope.pdf}}}},  
            Ananth~K\textsuperscript{2},  
            Arthi~A\textsuperscript{2},  
            Arunagiri~A\textsuperscript{2}, 
            Balaji~R\textsuperscript{2}~\\[5pt]{\textsuperscript{1}Department of Pharmaceutical Analysis, Dhanalakshmi Srinivasan College of Pharmacy, Thuraiyur Raod, Perambalur, Tamil Nadu {\textendash} 621212, India}~\\{\textsuperscript{2}Dhanalakshmi Srinivasan College of Pharmacy, Thuraiyur Raod, Perambalur, Tamil Nadu {\textendash} 621212, India}}

\begin{abstract}
Drugs as well as poor liquid efficiency and people enduring decadency in the aqueous medium might be in preference to formulated as solid products that include pills, powders, etc. The test that is carried out through the manufacture of impressive product comprises thickness, hardness, friability, dissolution time, disintegration time. The objective consisting of the present report was to document the requirements for the manufacturing of semisolid compounds. Ointments and creams are semisolid compounds given that external application program to the skin. The present report deals with an elaborated overview of comparative study in-process along with the finished product QC test for parenteral preparation. Injectables stay at substantial prominence on the earth market regardless of growing within the pharmaceutical grocery for 2-3 years. 
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}Tablets,\newline Capsules,\newline Solid Dosage Form,\newline Ointments,\newline Creams,\newline Quality Control Test,\newline Injectables
\end{keywords}
\twocolumn[ \maketitle {\printKwdAbsBox}]
\makeatletter{\raggedright{\Large$^\ast$}Corresponding Author\par Name:\ Prathap~B~\\ Phone:\ +91 81259 74910~\\  Email:\ prathapnila@gmail.com
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\section{Introduction}
Formulations have been pharmaceutical drug items in the form in which they will be marketed to be used, using a specific mixture of additives and resistless constituents in a particular form, along with meted out right into a particular dose. 

Indefinite quantity variety is that the manner of distinguishing spectacular drug that in physical variety in deciding variety, FDA explores fixed reasons given that, the form of the drug product before dishing out with the patient how spectacular product is administered \unskip~\cite{1277045:23741697}.

\textbf{Quality Control Test for Solid Dosag}\textbf{e } \textbf{Forms}

Solid formulations are going to be elements giving sure fashioned (shaped) and paperback manufactured the establishment which includes quick paralytic ingredients.

\textbf{Tablets}

Tablets tend to unit honorable medicine in now what usual dose of your drug has been right situated. Such will be popular compounds \unskip~\cite{1277045:23741698}.

\textbf{Unofficial Test}

\textbf{Appearance}

The tablets should be free from crack, depression, pinholes, etc. The color surface roughness polish of the tablets should be uniform on the whole surface \unskip~\cite{1277045:23741701}.

\textbf{Thickness}

The dimension of any tablet is measured by digital vernier calipers or screw gauges. Thickness properties such as its weighting consistency and also with compression force. The thickness of tablets is interrelated with distinctive tablet characteristics such that as its weight, consistency, and also with compression force \unskip~\cite{1277045:23741702}.

\textbf{Size and Shape}

The dimensions and diversity of the tablet could be geometric depicted regulated. It's regulated by the manufacture through the compressing process.

\textbf{Hardness }

It generally measures the tablet suppression intensity. It can be loaded requested to crush the tablet when put on its breaking point. The hardness of the tablet is tested by using Monsanto Tester, Pfizer tester, and eureka tester \unskip~\cite{1277045:23741745}.

\textbf{Pfizer Hardness Tester}

It functions similar to that of a pair of pliers. In the tester, the piston is connected to gauged which enables direct reading of the compression force applied. The readings were obtained in terms of kg or pounds \unskip~\cite{1277045:23741746}. The tablet is filled between the holding anvil and movable piston. The handle of the pliers is pressed until the tablet fracture. The force is read from the scale whose dial indicator returns to zero when the reset button is pressed. It is widely used because it was expensive, simple, and rapid to use.

\textbf{Official Test}

\textbf{Friability}

You will need tablet hardness as well as is planned to judge the facility of the tablet to withstand erosion in packaging, planning, and conveyance. It may be sounded respectively use of the Roche friabilator.

\textbf{Method}

10 Tablets are weighed collectively (W\ensuremath{_{1}}) and situated inside the chamber of friability. Inside the friability, the tablets are going to be exposed to rolling as a result of free fall tablets within the chambers of friability. Following 100 rotations the tablets are taken out from the friability \unskip~\cite{1277045:23741750}. The tablets tend to be weighed collectively (W\ensuremath{_{2}}). \% friability is set using the expression,

Friability = W\ensuremath{_{1}}-W\ensuremath{_{2}}/W\ensuremath{_{1}}*100

\textbf{Disintegration Test}

The disintegration test is carried to use the disintegration examiner which is composed going from a creel rack holding 6 tubes open at the top and bottom the bottom including telly is roofed by a 10 mesh screen \unskip~\cite{1277045:23741752}. To check for decay time, one tablet stretches each tube and therefore the basket rack prevails in the 1L beaker of water, SGF at 37\ensuremath{^{o}}C\ensuremath{\pm}2\ensuremath{^\circ}C, such pills stay 2.5 cm under the sphere of liquid on their upwardly movement.

\textbf{Dissolution Test}

Dissolution is the general appendage in which an excellent substance begins a solution. The flask can be maintained at 37\ensuremath{^{o}}C\ensuremath{\pm}2\ensuremath{^{o}}C by a constant temperature bath. Powerful motorial are often adjusted that one may turn at the given rate as well as sample distribution of the liquid will be withdrawn at intervals as far as determining the general amount of drug in solutions \unskip~\cite{1277045:23741777}.

\textbf{Weight Variation Test}

Weigh 20 tablets separately evaluate the weight as well as comparing of your exclusive tablet weight to the average \unskip~\cite{1277045:23741778}. The worth of your weight variation test is verbalized in percentage. The dissolution storage medium can be held in covered a 1000 ml field-glass vessel as well as keep going at 37\ensuremath{^\circ}C.

\textbf{Capsules}

The particular are unit solid product of medicaments in which the meted out are enveloped that in a soft or hard food-grade shell of an acceptable grade in regard gelatin.

\textbf{Content Uniformity Test}

The present test can be performed only the general content can be laid out in the person treatises. If the weighting of pills is crammed no need to consist of this test. In that 30 Capsules have been selected and 10 of these are tested (assay) separately. At least 9 of these contain 85 - 115\% of the drug and none contain below 75 - 125\% of the drug. If 1-23 of them fall outside of 85 - 115\% limits. The remaining 20 capsules are individually assayed and the requirements are met if no few then 27 contain 85-115\% of the drug and none contain less than 125\% of the drug \unskip~\cite{1277045:23741778}.

\textbf{Weight Uniformity Tes} \textbf{t}

20 capsules are selected and weighed individually, take the average and compare each capsule weight with the average. Then test passes if none of the individual weights are less than 90 \% and not more than 110 \% of average \unskip~\cite{1277045:23741782}.

\textbf{Disintegration Test}

Place 1 capsule each of the 6 tubes as well as add a disc to each tube. Pree on the temperature of your disintegration media at 37\ensuremath{\pm}2\ensuremath{^{o}}C as laid out in the individual discourses. A spectacular end of the point in time specified, lift the fluid and observe the capsules. All of the capsules have disintegrated completely. If 1 or 2 capsules fail to disintegrate completely, repeat the test on 12 additional capsules. No less than 16 out of 18 capsules tested disintegrate completely \unskip~\cite{1277045:23741783}.

\textbf{Dissolution Test}

Generally, USP 1 basket, USP 2 paddle, and IP 1 paddle and 2 basket apparatus will be used. It is all sometimes been used for capsules and floating-containing products capsules or to such that tend to disintegrate gradually. For the floating type of dosage forms, sinkers can be utilized up to prevent the floating containing capsules. It all includes a small wire (size 40) basket, swaying the ground involving a shaft it's well connected to an altitude motor. Other mesh sizes can also be utilized by required data documentation \unskip~\cite{1277045:23741785}. The basket can be decreased to the dissolution vessel containing dissolution medium such that it is at a high of 23 to 27 mm from the undersurface of the vessel.

\textbf{Quality Control Test for }\textbf{Semi-}\textbf{Solid Dosag}\textbf{e } \textbf{Forms}

It is defined as the preparation of drugs having a semisolid consistency that can be applied to the skin surface of the eye, nose, rectum, or vagina.

\textbf{Ointments and Creams}

Ointments are semi-solid coordinate systems of your drugs either or distributed or melted in an appropriate base meant for the application program to the skin and mucous membrane. The cream may be a topical preparation typically for applications programmed to spectacular skin \unskip~\cite{1277045:23742100}.

\textbf{Quality Control Test }

\textbf{In-Process Test}

\textbf{Appearance}

Appearance is considered one of the significant evaluation factors. It also ensures whether a lot of a batch of the preparation produced has maintained uniformity in its elegance which includes color and odor \unskip~\cite{1277045:23741786}.

\textbf{Colour}

These preparations are verified for their color. The color distribution within the preparation should be uniform and not vary from lot to lot.

\textbf{Odor }

Odour is an important criterion for preparation. It tells us if the preparation is deteriorated, thereby indicating the stability of preparation.

\textbf{Particle Size}

The particle size should be something that must be uniformly dispersed throughout the vehicle to ensure homogeneity of the product. Particles less than 74 microns in size are equivalent to the mesh openings in a 200 mesh sieve within the U.S. well known sieve series is non-irritant to most people.

\textbf{Consistency}

The consistency or hardness of warm-up was sounded by a penetrometer.

\textbf{Grittiness}

The particles in the powder should be impalpable to the touch otherwise grittiness results. A small number of preparations was taken on the palm and rubbed with finger to feel for grittiness. It is also inspected for any foreign particle or black particle.

\textbf{Finished Product Test}

\textbf{Test for Non-Irritancy}

Non irritancy containing the preparation can be examined with the aid of a skin (patch) test. During this test 24, human volunteers will be chosen. The absolute value about preparation is often applied daily on though vertebral column (back) or volar forearm (intact skin) given that 21 days. Daily the kind of pharmacologic action at law referred to may be noted. No visible reaction or erythema or intense erythema with edema and vesicular erosion should occur. An excellent ointment base exhibits no viewable chemical reaction.

\textbf{Test for the Rate of Penetration}

Using flow through diffusion cell or micro-dialysis method, the rate of penetration of the preparation can be estimated. Animal or human skin of definite area should be collected and tied to the holder present in the diffusion cell. The diffusion cell is put in the fluid bath. Measured quantity of the preparation is applied over the skin and the amount of drug passed into the fluid is measured at regular intervals by analyzing the aliquots of fluid using a spectrometer.

\textbf{T}\textbf{est for Content Uniformity} \textbf{\space }

Nearly ten ointment tubes are selected at random. The clean spectacular surface of the container and weighing for each one container wipe away subjectively the table of contents from for each one contains. Evaluate every empty container. The overall aggregate weight of one's contents of the 10 packing containers is typically at least the labeled time interval along with the net weight wittiness any single container may be at least 91\% and not more than 109\% of the tagged amount where the labeled time interval is 50gm.

\textbf{Test for Microbial Content}

Microorganisms benefit from \textit{pseudomonas aeruginosa } plus \textit{Staphylococcus aureus } may foul the warm-up and eventually touch the skin \unskip~\cite{1277045:23742158}. So semisolid formulation needs to be tested the absenteeism of such microorganisms.

\textbf{Test for \textit{Pseudomonos aeruginosa}}

\textit{Pseudomonas aeruginosa }is a gram-negative organism and it contains abundant amounts of cytochrome oxidase enzyme. The presence of the enzyme in the preparation is interpreted as the presence of the organism. For each one sampling will be inoculated in a very nutrient broth medium found in the test tube. All the test tubes are incubated at 37\ensuremath{^{o}}C for 18-24 hrs. After incubation 0.2ml of \ensuremath{\alpha }-naphthol and 0.3ml of p-aminodimethylaniline oxalate are added to each tube. Immediately the test tubes were shaken vigorously for thorough oxygenation of the contents. No blue color should appear if the test preparation does not contain the enzyme and the microorganism \textit{Ps}e\textit{udomonas aeruginosa.}

\textbf{Procedure}

Using pour plate technique, the number of microorganisms initially presents in the preparation is determined. The solutions of different samples of the preparation are made and mixed with that broth separately [Figure~\ref{f-d669c943a491}] \unskip~\cite{1277045:23742158}. All cultures containing the microorganisms tend to be further in the direction of through to for each one mixture under aseptic situations all of the combinations are incubated \unskip~\cite{1277045:23741788}. The quantity of microorganism's watch representative sample is going to be counted on the 7\ensuremath{^{th}}, 14\ensuremath{^{th}}, 21\ensuremath{^{st }}and 28\ensuremath{^{th}} days of inoculation\textbf{.}


\bgroup
\fixFloatSize{images/03f5b2ca-3061-4fa4-819b-82c99c025f29-upicture1.png}
\begin{figure}[!htbp]
\centering \makeatletter\IfFileExists{images/03f5b2ca-3061-4fa4-819b-82c99c025f29-upicture1.png}{\includegraphics{images/03f5b2ca-3061-4fa4-819b-82c99c025f29-upicture1.png}}{}
\makeatother 
\caption{\boldmath {Culture Medium of Micro Organisms}}
\label{f-d669c943a491}
\end{figure}
\egroup
\textbf{Microbial Limits}

On the 14\ensuremath{^{th}} day, the variety of vegetative cells shouldn't be over 0.1\% of the initial put concentration. The viable yeasts and molds should be below or equal to initial concentrations. On the 28\ensuremath{^{th}} day, the quantity of microbes has to be below or adequate to the first concentrations.

\textbf{Suppositories}\ensuremath{^{\textbf{\space }}}

The suppository is used to speechify drugs by perfusion into a body orifice wherever it sizzles or melts to exert local or systemic effects.

\textbf{Evaluation of Suppositories}

\textbf{Test for Physical Strength}

The overall apparatus used the reason that the reason being referred to as breakage test apparatus, which includes a dual walled chamber by which water serves as pumped to preserve 37\ensuremath{^\circ}C temperature in between the two walls consisting of the overall chamber. The inner chamber contains a disc since holding the general suppositories \unskip~\cite{1277045:23741920}. To the present disc, a rod is hooked up. All the weights victimized will be adding which supplies the tensile strength.

\textbf{Melting Range Test}

It serves as the time taken over through an intact suppository to melt during a humidity levels water bath. The general suppository is mixed upon a constant water bath, ultimately the melting range is recorded.

\textbf{Uniformity of Drug Content}

This will be administered by way of acting tests for various suppositories. All the suppositories ought to suppress the same reported quantity.

\textbf{Test for Softening Time}

The present test studies the softening or liquefaction time regarding suppository that displays the hardness involving the general groundwork (base). The apparatus includes a cellophane tube tied at the two ends of the capacitor. The couple comes to an end with the cellophane tube that has been opened \unskip~\cite{1277045:23741928}. Water is often circulated through the overall condenser at a certain rate. As a result after some time, the higher half of the box grows along with the lower half collapses. The period by which the suppository melts entirely is thought of as for softening time.

\textbf{Quality Control Test for Liquid Dosage Forms}

Dosage forms are essentially pharmaceutical products in the form which involves a mixture of active drug components and excipients. Liquid form of a dose of a drug used as a drug or medication intended for administration or consumption.

\textbf{Parenterals}

These are the sterile formulations that are administered to the vaccine by a route anyways of the alimentary canal.

\textbf{Quality Control Test} \textbf{Parental\ensuremath{^{}}}

\textbf{Sterility Tests}

Sterility trying out attempts to reveal the ubiety or omission of viable micro-organisms \unskip~\cite{1277045:23741931}.

\textbf{Membrane Filtration Method}

Washing up the filters alongside fluids to take away repressive properties, diluting the overall membranes aseptically inside equal parts together with shifting one among the general portions separately style of culture medium used. The media have been afterward conceived under prescribed conditions.

\textbf{Pyrogen Test}

\textbf{Lal Test}

The \textit{in-vitro} assay wont to detect and put concentration concerning bacterial endotoxins in medicine as well as biologic products [Figure~\ref{f-4b262a5cbd37}]. The whole rate involving reaction is determined by the put concentration of endotoxins, pH, and low temperature along with the presence of a clotting enzyme system as well as citable proteins from the lysate \unskip~\cite{1277045:23741972}.


\bgroup
\fixFloatSize{images/5b5c1156-10e8-4995-a35c-64eef1308f82-upicture2.png}
\begin{figure}[!htbp]
\centering \makeatletter\IfFileExists{images/5b5c1156-10e8-4995-a35c-64eef1308f82-upicture2.png}{\includegraphics{images/5b5c1156-10e8-4995-a35c-64eef1308f82-upicture2.png}}{}
\makeatother 
\caption{\boldmath {Diagram of LAL Test}}
\label{f-4b262a5cbd37}
\end{figure}
\egroup
\textbf{Pyrogen Test or Fever Response of Rabbit}

Rabbits experience pyrogen disposition to humans, and by viewing a transformation simultaneously coldness in rabbits you can plan to inhibit the ubiquity simultaneously coldness in rabbits you can inhibit the ubiquity of pyrogens [Figure~\ref{f-eae7f3f1e1ab}].


\bgroup
\fixFloatSize{images/44c1781c-3385-4a2f-98db-7c89be481de2-upicture3.png}
\begin{figure}[!htbp]
\centering \makeatletter\IfFileExists{images/44c1781c-3385-4a2f-98db-7c89be481de2-upicture3.png}{\includegraphics[width=\linewidth]{images/44c1781c-3385-4a2f-98db-7c89be481de2-upicture3.png}}{}
\makeatother 
\caption{\boldmath {Diagram of Rabbit Test}}
\label{f-eae7f3f1e1ab}
\end{figure}
\egroup
\textbf{Procedure}

Track record the primary temperature of the rabbits, some rabbit showing up a room temperature way over 39\ensuremath{^{o}}C needs to be exempted. Immunize the representative sample into the ear vein of each rabbit. Check the temperature after 30 mins, 1, 2, and 3 hours.

\textbf{Result}

The current test serves as +ve every rabbit demonstrate an increase in temperature. Therefore, 2 of three rabbits demonstrate temperature increases; rephrase the test employing a grouping of the five tests might be positive if the four of the five rabbit. Shrew temperature increases.

\textbf{Weight Variation Test}

The weight about of 10 individual sterile units is often renowned and the content serves as is removed from them and the empty individual sterile unit will be weighting intern. Subsequently, net weight serves as calculated by subtracting empty sterile unit weight from the gross weight \unskip~\cite{1277045:23741977}. The overall dose uniformity is often met if the general amount of active ingredients can be within the range of 85 {\textendash} 115 \% consisting of the label assertion weight variation method.
    
\section{CONCLUSION}
Every sort of dosage form is exclusive in physical and pharmaceutical properties. The best pattern and formulation about a dosage form needs deliberation involving the physical, chemical as well as biological features involving all the drug supplies and pharmaceutical ingredients for use in fabricating the product.
    
\section{ACKNOWLEDGEMENT\textbf{\space }}
I would like to thank Chairman (Dhanalakshmi Srinivasan Garu) Dhanalakshmi Srinivasan College of Pharmacy, Thuraiyur Raod, Perambalur, Tamil Nadu {\textendash} 621212, India.

\textbf{Conflict of Interest} \textbf{\space }

The authors attest that they have no conflict of interest in this study. 

\textbf{Funding Support} \textbf{\space }

The authors declare that there is no financial support for the current study.
    

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