Introduction
Product Quality is directly proportional to Analytical Quality Analytical Solutions has been actively engaged in executing projects such as Analytical method development and Method validations for various tests on Pharmaceutical products, since 2003 Pharmaceutical research and development particularly in the field of !on "hromatographic evaluations is a niche activity Analytical Solutions has a great advantage in this field due to more than #0 years experience $ith leading !on "hromatograph Manufacturer S%ill, expertise and regulatory %no$ledge give an edge to Analytical Solutions for conduct of Stability Studies on Pharmaceutical products Analytical Solutions is engaged in &io'analytical research for the benefit and betterment of the healthcare system and pharmacy profession Analytical Solutions delivers (uality in every aspect and is evident from the feather in cap !S) *00#+2000 certification it achieved $ith in years time of establishment ,act is also evident from the various customers from -SA and other parts of the $orld that the ./P systems in the laboratory are $ell accepted by business houses $orld over
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Who are we
!n the highly competitive $orld, Analytical Solutions is all set to prove to be a mar%et innovator by combining traditional "1) services $ith non traditional services and electronically enhanced processes 0he result is a high' energy, flexible organi2ation that can reach globally to support the pharmaceutical industries )ur area of expertise covers a full range of services related to total analytical support, regulatory compliance and documentation for product registration Analytical Solutions is able to deliver customi2ed support to each client depending upon their strategic goals Analytical Solutions provides its personnel $ith up to date %no$ledge and information through training courses time and again 0raining records for each team member is scrupulously maintained in an easily traceable form Analytical Solutions team members are $ell versed $ith $or%ing in regulatory environment 0he t$o 3irectors of Analytical Solutions have over 40 years of combined industry experience 5ith extensive %no$ledge in separation sciences and (uality assurance 3irectors of Analytical Solutions are able to ensure that each customer is $ell satisfied $ith the projects contracted to Analytical Solutions
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Choosing Analytical Solutions
"hoosing one group over another is an important decision Some of the tools mentioned here are important 5e are committed to our clients, regardless of project si2e Analytical Solutions understands that maintaining confidentiality is the greatest $orry of an outsourcer Analytical Solutions firmly assures the outsourcer that at Analytical Solutions this $orry shall turn in to total trust 5e are open for 6"onfidentiality Agreements7 Analytical Solutions strive to create 6$in'$in7 Partnerships Analytical Solutions have forged strategic partnerships $ith experienced niche companies Analytical Solutions team $or%s the project from beginning to end
6Analytical Solutions experience and technology to execute creative solutions for our customers is $hat ma%es this business mutually re$arding 1epeat business of Analytical Solutions is a testimony to the appreciation our customers have for our expertise, resourcefulness and ability, to consistently exceed expectations 7 Analytical Solutions al$ays delivers (uality Analytical Solutions develops (uality solutions !mprove (uality $ith our solutions Solutions for analytical excellence
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List of key Persons
Dr. V. . !hate "#.Sc.$ Ph. D.%
5ith industry experience of about 28 years in the field of Analytical !nstrumentation and Pharmaceutical 1 9 3, he is an inspiration to all staff members :e has $or%ed $ith esteemed pharma companies such as "ipla /td , ;opran /td , Sun Pharma and is associated $ith pioneers in !on "hromatography < 3ionex "orp = of -SA for last #2 years Dr. A. &. Vaidya " #.Sc.$ Ph.D. % >oung and 3ynamic $ith industry experience of about #8 years in the field of Analytical 3evelopment and ?uality Assurance :e has $or%ed $ith esteemed pharma companies such as "ipla /td , 1houne'Poulenc, ,3" /td and Sun Pharma 3r @aidya $ith varied experience of regulatory audits is a %ey person for ?uality Management Systems of the organisation
Analytical Solutions pro'ides a total solution to Phar(aceutical Industry for pro)ects fro( analytical de'elop(ent to *ioe+ui'alence studies and technical dossiers
#ethod De'elop(ent
As per the latest regulatory re(uirements, a stability indicating method for analysis is a must 5e develop methods that are suitable for the intended purpose 3eveloping methods forAssay content$ ,sti(ation of i(purities and degradation products$ In-'itro profiling are Analytical Solutions specialties
#ethod Validation
As per !":, -SPA-S,3A, M"A and 0.A re(uirements or as per customer defined protocol "arrying out ,orced 3egradation to prove specificity is a %ey in this area Analytical Solutions performs this activity to the best possible .LP co(pliance 0he data generated can $ithstand all regulatory re(uirements 5ith attractive, to the point presentation $e ma%e an excellent technical document
Sta*ility Studies
Analytical Solutions has most needed facility to cover product sta*ility as per IC/ guidelines. 0he %no$ledge and understanding our experts have on various aspects of product performance characteristics $ould be an advantage for Pharmaceutical !ndustry
Ion Chro(atography
5ith more and more pharmaceutical products coming under stringent rules for residual ionic i(purities$ this is the field for industry to loo% at Analytical Solutions to provide their experience for product compliance Pharmaceutical manufacturers can avail the Analytical Solutions immense s%ill, expertise and experience in !on "hromatography B1efer solutions already providedC
!io-analytical support
:aving /"'MSAMS 9 :P/" $ith all types of sensitive detection devices e g amperometry, fluorescence, etc and experience we pro'ide un*iased single *linded analysis. 0his is possible as clinical part of &AA&D studies is performed by our associate "linical 1esearch !nstitutes More than 20 methods for estimation of analytes from biological fluids using :P/" already developed
0herapeutic Drug #onitoring
"ritical evaluations of drug levels in patients e g Siroli(us " apa(ycin%, "yclosporine A, Amiodarone, /amotrigine, etc using :P/" is much more accurate, specific and reproducible as compared to conventional techni(ues Dstimation of these as $ell as a "ardiovascular Mar%er such as /o(ocysteine $ould give 3octors confidence to decide on the treatment
egulatory Affairs
Analytical Solutions is engaged in preparation of Drug #aster 1iles in C0D format and 0echnical 3ossiers 5ith focused staff for ma%ing registration documents and analytical expertise Analytical Solutions $ould be an ideal site for Pharmaceutical manufacturers to rely on the registration documents $ith minimum or no (ueries from regulatory bodies
0raining and La*oratory set up
extending our expertise in this field for your benefit
A total solution to development projects from Analytical Method 3evelopment to &ioe(uivalence studies
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,-MD "-P&)A13 S0A&!/!0> ":AM&D1 20G"AH0I 1: S0A&!/!0> ":AM&D1 30G"AH8I 1: S0A&!/!0> ":AM&D1 40G"AJ8I1: 3DDP ,1DDKD1 ")/3 "DE01!,-.D MA":!ED .AS .DED1A0)1 SAMP/D D@AP)1A0)1 AE3 ")E"DE01A0)1 5A0D1 P-1!,!"A0!)E S>S0DM 5!0: )E/!ED 0)" M)E!0)1!E. Analytical area Method development 9 validations B,e$ examples of Products on $hich projects $e have completedC
Products
Dtoposide :ydrocortisone and Pramoxine hydrochloride "ladribine "PM Syrup 1amipril "a Pantothenate ,olic acid, Eiacinamide, 0hiamine :"l Eon'oxynol * @enlafaxine :"l &iotin "yanocobalamine &icalutamide Phenytoin Ea 0olterodine 0artrate &udesonide Paracetamol 0halidomide &ambuterol :"l ?uinapril :"l Methima2ole )mepra2ole 9 3omperidone 0heophylline /isinopril 9 :ydrochlorothia2ide "efuroxine Axetil ,lucloxacillin Ea 0op
!n'vitro profiling "omparative dissolution profiles $ith !nnovator A 1eference listed product Similarity and dissimilarity factors and discriminatory dissolution media are the %ey in this $or% !n' vitro profile did for products e g /isinopril, 1amipril, /isinopril F :ydrochlorothia2ide, etc 0op !on "hromatographic Dvaluations D(uipped to carry out all types of ion "hromatographic evaluations such as+ Dstimation of "ations did in Pharmaceuticals, dyes and chemicals Methods standardi2ed for estimation of Monomethylamine, 3imethylamine, 0riethylamine, E'methylpyrrolidine, etc Dstimation of Anions did in Pharmaceuticals, dyes and chemicals Methods standardi2ed for Acetate, Sulphate 9 Sulphamate, A2ide, Polyphosphates, D30A, "yanide, )xalate, etc
)ther than common cations 9 anions $e also have methods for 0ransition metals, Sugars, :ydra2ine, )rganic acids Stability Studies on AP! 9 3rug Products State of the art .MP models of Stability "hambers are being utili2ed for monitoring Stability of AP!=s 9 3rug Products of various companies !n &io'analytical area Patients are being monitored for 0herapeutic drug monitoring Patients are being monitored for 1apamycin /amotrigine Amiodarone :omocysteine Analytical part of &A A &D studies done for
,exofenadine Drdostein ,ors%olin .ranisetron 0ra2odone :"l 0op Method available for .uaiphenesin Pantopra2ole
1egulatory Affairs
Preparation of ")S A "!3
Products ' Meloxicam ,lucloxacillin Ea 0heophylline "affeine Dtophylline
Aminophylline 0heobromine Phenytoin Ea